lead_sponsor: Celgene

summary: The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.

ReferenceCitation: Santini V, Almeida A, Giagounidis A, Gropper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Canizo C, Gattermann N, Ozawa K, Risueno A, MacBeth KJ, Zhong J, Seguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized Phase III Study of Lenalidomide Versus Placebo in RBC Transfusion-Dependent Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes and Ineligible for or Refractory to Erythropoiesis-Stimulating Agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. doi: 10.1200/JCO.2015.66.0118. Epub 2016 Jun 27.

ReferenceCitation: Santini V, Almeida A, Giagounidis A, Skikne B, Beach CL, Weaver J, Tu N, Fenaux P. Achievement of red blood cell transfusion independence in red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes correlates with serum erythropoietin levels. Leuk Lymphoma. 2020 Jun;61(6):1475-1483. doi: 10.1080/10428194.2020.1719088. Epub 2020 Feb 17.

repository_institution: University of Florence - Florence Research

ReferenceCitation: Almeida A, Fenaux P, Garcia-Manero G, Goldberg SL, Gropper S, Jonasova A, Vey N, Castaneda C, Zhong J, Beach CL, Santini V. Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial. Leuk Lymphoma. 2018 Sep;59(9):2135-2143. doi: 10.1080/10428194.2017.1421758. Epub 2018 Jan 11.

location_facility: Policlinico Agostino Gemelli - Istituto di Ematologia

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Princess Margaret Hospital and University of Toronto

location_facility: Klinikum Mannheim der Universitat Heidelberg

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Royal Adelaide Hospital Institute of Medical and Veterinary Science

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Center Hospitalier Universitaire Ambroise Pare

location_facility: Katedra i Klinika Hematologii i Transplantacji Szpiku - SLASKIEGO UNIWERSYTETU MEDYCZNEGO

location_facility: McGill University, Dept. Oncology Clinical Research Program

location_facility: Universitatsklinik fur Innere Medizin Salzburg

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: P.O. Ospedale Roberto Binaghi (UNI CA/ASL 8)

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Az. Osp. SS.Antonio e Biagio - SC Ematologia

location_facility: Groupe hospitalier Cochin Saint-Vincent de Paul

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: BAG Freiberg-Richter, Jacobash, Illmer, Wolf

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare The Efficacy And Safety of Lenalidomide (Revlimid®) Versus Placebo In Subjects With Transufsion-Dependent Anemia Due to IPSS Low Or Imtermidate-1 Risk Myelodysplastic Syndromes Without Deletion 5Q(31) And Unresponsive Or Refractory To Erthropoiesis-Stimulating Agents

location_country:
Germany
Italy
Poland
Portugal
Israel
United Kingdom
Australia
Japan
Austria
Belgium
United States
Spain
Turkey
Czechia
Canada
France


type: Other Identifier

title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy

acronym: REACTT

summary: The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Montorsi F, Oelke M, Henneges C, Brock G, Salonia A, d'Anzeo G, Rossi A, Mulhall JP, Buttner H. Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy. Eur Urol. 2016 Sep;70(3):529-37. doi: 10.1016/j.eururo.2016.02.036. Epub 2016 Mar 3.

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Patel HR, Ilo D, Shah N, Cuzin B, Chadwick D, Andrianne R, Henneges C, Barry J, Hell-Momeni K, Branicka J, Buttner H. Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study. BMC Urol. 2015 Apr 12;15:31. doi: 10.1186/s12894-015-0022-9.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Montorsi F, Brock G, Stolzenburg JU, Mulhall J, Moncada I, Patel HR, Chevallier D, Krajka K, Henneges C, Dickson R, Buttner H. Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Eur Urol. 2014 Mar;65(3):587-96. doi: 10.1016/j.eururo.2013.09.051. Epub 2013 Oct 13.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Switzerland
Belgium
Spain
Canada
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study of the Safety and Response Rate of 3 Subcutaneously Administered Doses of 5 X 10^7 PFU RO5217790 in Patients With High Grade Cervical Intraepithelial Neoplasia Grade 2 or 3 Associated With High Risk HPV Infection

summary: This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Belgium
United States
Spain
Puerto Rico
France


study_start_date_type: Actual

acronym: Neptune II

lead_sponsor: Astellas Pharma Europe B.V.

summary: Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

title: An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

source: euctr

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Germany
Belarus
Italy
Poland
Slovakia
United Kingdom
Netherlands
Austria
Belgium
Czechia
France

ipd_sharing: Yes


title: Efficacy and Safety Comparison of Epiduo Gel Associated With Lymecycline 300 mg Capsules Versus Epiduo Vehicle Gel Associated With Lymecycline 300 mg Capsules in the Treatment of Moderate to Severe Acne Vulgaris

acronym: TEAM

summary:
Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.

The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.

The safety of the two treatment regimens will also be evaluated.

lead_sponsor: Galderma R&D

location_country: Germany Italy Poland Australia Brazil Sweden Mexico Belgium France


acronym: GALILEO

intervention_type: Other

lead_sponsor: Bayer

summary: To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

ReferenceType: result

ReferenceCitation: Holz FG, Roider J, Ogura Y, Korobelnik JF, Simader C, Groetzbach G, Vitti R, Berliner AJ, Hiemeyer F, Beckmann K, Zeitz O, Sandbrink R. VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study. Br J Ophthalmol. 2013 Mar;97(3):278-84. doi: 10.1136/bjophthalmol-2012-301504. Epub 2013 Jan 7. Erratum In: Br J Ophthalmol. 2015 Dec;99(12):1746.

publisher_dissemination: British Medical Journal

ReferenceCitation: Korobelnik JF, Holz FG, Roider J, Ogura Y, Simader C, Schmidt-Erfurth U, Lorenz K, Honda M, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal Aflibercept Injection for Macular Edema Resulting from Central Retinal Vein Occlusion: One-Year Results of the Phase 3 GALILEO Study. Ophthalmology. 2014 Jan;121(1):202-208. doi: 10.1016/j.ophtha.2013.08.012. Epub 2013 Sep 29.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - SHS

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repositories_concat: HAL

sponsor_collaborators:
Bayer
Regeneron Pharmaceuticals

title: A Randomized, Double-masked, Sham-controlled Phase 3 Study of the Efficacy, Safety and Tolerability of Repeated Intravitreal Administration of VEGF Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

location_country:
Germany
Italy
Hungary
Singapore
Australia
Japan
Austria
Korea, Republic of
Latvia
France


acronym: POINT

summary:
A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common [25], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

status: Terminated

ReferenceType: background

ReferenceCitation: Ovbiagele B. Antiplatelet therapy in management of transient ischemic attack: overview and evidence-based rationale. J Emerg Med. 2008 May;34(4):389-96. doi: 10.1016/j.jemermed.2007.08.056. Epub 2008 Jan 18.

ReferenceCitation: Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. doi: 10.1016/S1474-4422(07)70274-0. Epub 2007 Nov 13.

ReferenceCitation: Kernan WN, Schindler JL. Rapid intervention for TIA: a new standard emerges. Lancet Neurol. 2007 Nov;6(11):940-1. doi: 10.1016/S1474-4422(07)70249-1. No abstract available.

ReferenceCitation: Rothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4. doi: 10.1136/hrt.2007.121111.

ReferenceCitation: Streifler JY. Early stroke risk after a transient ischemic attack: can it be minimized? Stroke. 2008 Jun;39(6):1655-6. doi: 10.1161/STROKEAHA.107.510248. Epub 2008 Mar 27. No abstract available.

ReferenceCitation: Dean N, Shuaib A. Transient ischaemic attacks: unstable, treatable, neglected. Lancet. 2007 Oct 20;370(9596):1398-400. doi: 10.1016/S0140-6736(07)61449-4. No abstract available.

ReferenceCitation: Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. doi: 10.1016/S1474-4422(07)70250-8. Epub 2007 Oct 10.

ReferenceCitation: Geisler T, Zurn C, Paterok M, Gohring-Frischholz K, Bigalke B, Stellos K, Seizer P, Kraemer BF, Dippon J, May AE, Herdeg C, Gawaz M. Statins do not adversely affect post-interventional residual platelet aggregation and outcomes in patients undergoing coronary stenting treated by dual antiplatelet therapy. Eur Heart J. 2008 Jul;29(13):1635-43. doi: 10.1093/eurheartj/ehn212. Epub 2008 May 24.

ReferenceCitation: Lotfi A, Schweiger MJ, Giugliano GR, Murphy SA, Cannon CP; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients--a Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J. 2008 May;155(5):954-8. doi: 10.1016/j.ahj.2007.12.009. Epub 2008 Feb 19.

ReferenceCitation: Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. doi: 10.1161/01.CIR.0000124581.18191.15. Epub 2004 Mar 15.

ReferenceCitation: Riondino S, Petrini N, Donato L, Torromeo C, Tanzilli G, Pulcinelli FM, Barilla F. Effects of rosuvastatin on platelet inhibition by clopidogrel in cardiovascular patients. J Thromb Thrombolysis. 2009 Aug;28(2):151-5. doi: 10.1007/s11239-008-0254-6. Epub 2008 Jul 18.

ReferenceCitation: Saw J, Brennan DM, Steinhubl SR, Bhatt DL, Mak KH, Fox K, Topol EJ; CHARISMA Investigators. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007 Jul 24;50(4):291-5. doi: 10.1016/j.jacc.2007.01.097. Epub 2007 Jul 10.

ReferenceCitation: Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003 Aug 26;108(8):921-4. doi: 10.1161/01.CIR.0000088780.57432.43. Epub 2003 Aug 18.

ReferenceCitation: Trenk D, Hochholzer W, Frundi D, Stratz C, Valina CM, Bestehorn HP, Buttner HJ, Neumann FJ. Impact of cytochrome P450 3A4-metabolized statins on the antiplatelet effect of a 600-mg loading dose clopidogrel and on clinical outcome in patients undergoing elective coronary stent placement. Thromb Haemost. 2008 Jan;99(1):174-81. doi: 10.1160/TH07-08-0503.

ReferenceCitation: Johnston SC, Gress DR, Browner WS, Sidney S. Short-term prognosis after emergency department diagnosis of TIA. JAMA. 2000 Dec 13;284(22):2901-6. doi: 10.1001/jama.284.22.2901.

ReferenceCitation: Coutts SB, Eliasziw M, Hill MD, Scott JN, Subramaniam S, Buchan AM, Demchuk AM; VISION study group. An improved scoring system for identifying patients at high early risk of stroke and functional impairment after an acute transient ischemic attack or minor stroke. Int J Stroke. 2008 Feb;3(1):3-10. doi: 10.1111/j.1747-4949.2008.00182.x.

ReferenceCitation: Coutts SB, Simon JE, Eliasziw M, Sohn CH, Hill MD, Barber PA, Palumbo V, Kennedy J, Roy J, Gagnon A, Scott JN, Buchan AM, Demchuk AM. Triaging transient ischemic attack and minor stroke patients using acute magnetic resonance imaging. Ann Neurol. 2005 Jun;57(6):848-54. doi: 10.1002/ana.20497.

ReferenceCitation: Algra A, van Gijn J, Halkes PH, Kappelle LJ, Koudstaal PJ; ESPRIT Study Group. Interpretation of ESPRIT in the FASTER trial. Lancet Neurol. 2008 Mar;7(3):198-9; author reply 199. doi: 10.1016/S1474-4422(08)70030-9. No abstract available.

ReferenceCitation: Lavallee PC, Meseguer E, Abboud H, Cabrejo L, Olivot JM, Simon O, Mazighi M, Nifle C, Niclot P, Lapergue B, Klein IF, Brochet E, Steg PG, Leseche G, Labreuche J, Touboul PJ, Amarenco P. A transient ischaemic attack clinic with round-the-clock access (SOS-TIA): feasibility and effects. Lancet Neurol. 2007 Nov;6(11):953-60. doi: 10.1016/S1474-4422(07)70248-X.

ReferenceCitation: Luengo-Fernandez R, Gray AM, Rothwell PM. Effect of urgent treatment for transient ischaemic attack and minor stroke on disability and hospital costs (EXPRESS study): a prospective population-based sequential comparison. Lancet Neurol. 2009 Mar;8(3):235-43. doi: 10.1016/S1474-4422(09)70019-5. Epub 2009 Feb 4.

ReferenceCitation: Yusuf S, Diener HC, Sacco RL, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, VanderMaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Telmisartan to prevent recurrent stroke and cardiovascular events. N Engl J Med. 2008 Sep 18;359(12):1225-37. doi: 10.1056/NEJMoa0804593. Epub 2008 Aug 27.

ReferenceCitation: Sacco RL, Diener HC, Yusuf S, Cotton D, Ounpuu S, Lawton WA, Palesch Y, Martin RH, Albers GW, Bath P, Bornstein N, Chan BP, Chen ST, Cunha L, Dahlof B, De Keyser J, Donnan GA, Estol C, Gorelick P, Gu V, Hermansson K, Hilbrich L, Kaste M, Lu C, Machnig T, Pais P, Roberts R, Skvortsova V, Teal P, Toni D, Vandermaelen C, Voigt T, Weber M, Yoon BW; PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51. doi: 10.1056/NEJMoa0805002. Epub 2008 Aug 27.

ReferenceCitation: Brown RD Jr, Petty GW, O'Fallon WM, Wiebers DO, Whisnant JP. Incidence of transient ischemic attack in Rochester, Minnesota, 1985-1989. Stroke. 1998 Oct;29(10):2109-13. doi: 10.1161/01.str.29.10.2109.

ReferenceCitation: Kissela B, Broderick J, Woo D, Kothari R, Miller R, Khoury J, Brott T, Pancioli A, Jauch E, Gebel J, Shukla R, Alwell K, Tomsick T. Greater Cincinnati/Northern Kentucky Stroke Study: volume of first-ever ischemic stroke among blacks in a population-based study. Stroke. 2001 Jun;32(6):1285-90. doi: 10.1161/01.str.32.6.1285.

ReferenceCitation: Williams GR, Jiang JG, Matchar DB, Samsa GP. Incidence and occurrence of total (first-ever and recurrent) stroke. Stroke. 1999 Dec;30(12):2523-8. doi: 10.1161/01.str.30.12.2523.

ReferenceCitation: Kleindorfer D, Panagos P, Pancioli A, Khoury J, Kissela B, Woo D, Schneider A, Alwell K, Jauch E, Miller R, Moomaw C, Shukla R, Broderick JP. Incidence and short-term prognosis of transient ischemic attack in a population-based study. Stroke. 2005 Apr;36(4):720-3. doi: 10.1161/01.STR.0000158917.59233.b7. Epub 2005 Feb 24.

ReferenceCitation: Edlow JA, Kim S, Pelletier AJ, Camargo CA Jr. National study on emergency department visits for transient ischemic attack, 1992-2001. Acad Emerg Med. 2006 Jun;13(6):666-72. doi: 10.1197/j.aem.2006.01.014. Epub 2006 Apr 11.

ReferenceCitation: Howard G, Toole JF, Frye-Pierson J, Hinshelwood LC. Factors influencing the survival of 451 transient ischemic attack patients. Stroke. 1987 May-Jun;18(3):552-7. doi: 10.1161/01.str.18.3.552.

ReferenceCitation: Shah KH, Kleckner K, Edlow JA. Short-term prognosis of stroke among patients diagnosed in the emergency department with a transient ischemic attack. Ann Emerg Med. 2008 Mar;51(3):316-23. doi: 10.1016/j.annemergmed.2007.08.016. Epub 2007 Oct 25. Erratum In: Ann Emerg Med. 2008 Jun;51(6):774.

ReferenceCitation: Wu CM, McLaughlin K, Lorenzetti DL, Hill MD, Manns BJ, Ghali WA. Early risk of stroke after transient ischemic attack: a systematic review and meta-analysis. Arch Intern Med. 2007 Dec 10;167(22):2417-22. doi: 10.1001/archinte.167.22.2417.

ReferenceCitation: Gladstone DJ, Kapral MK, Fang J, Laupacis A, Tu JV. Management and outcomes of transient ischemic attacks in Ontario. CMAJ. 2004 Mar 30;170(7):1099-104. doi: 10.1503/cmaj.1031349.

ReferenceCitation: Lisabeth LD, Ireland JK, Risser JM, Brown DL, Smith MA, Garcia NM, Morgenstern LB. Stroke risk after transient ischemic attack in a population-based setting. Stroke. 2004 Aug;35(8):1842-6. doi: 10.1161/01.STR.0000134416.89389.9d. Epub 2004 Jun 10.

ReferenceCitation: Eliasziw M, Kennedy J, Hill MD, Buchan AM, Barnett HJ; North American Symptomatic Carotid Endarterectomy Trial Group. Early risk of stroke after a transient ischemic attack in patients with internal carotid artery disease. CMAJ. 2004 Mar 30;170(7):1105-9. doi: 10.1503/cmaj.1030460.

ReferenceCitation: Hill MD, Yiannakoulias N, Jeerakathil T, Tu JV, Svenson LW, Schopflocher DP. The high risk of stroke immediately after transient ischemic attack: a population-based study. Neurology. 2004 Jun 8;62(11):2015-20. doi: 10.1212/01.wnl.0000129482.70315.2f.

ReferenceCitation: Rothwell PM, Giles MF, Flossmann E, Lovelock CE, Redgrave JN, Warlow CP, Mehta Z. A simple score (ABCD) to identify individuals at high early risk of stroke after transient ischaemic attack. Lancet. 2005 Jul 2-8;366(9479):29-36. doi: 10.1016/S0140-6736(05)66702-5.

ReferenceCitation: Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. doi: 10.1161/01.STR.0000080935.01264.91. Epub 2003 Jul 10.

ReferenceCitation: Rao SV, Ohman EM, Granger CB, Armstrong PW, Gibler WB, Christenson RH, Hasselblad V, Stebbins A, McNulty S, Newby LK. Prognostic value of isolated troponin elevation across the spectrum of chest pain syndromes. Am J Cardiol. 2003 Apr 15;91(8):936-40. doi: 10.1016/s0002-9149(03)00107-3.

ReferenceCitation: Whisnant JP, Matsumoto N, Elveback LR. Transient cerebral ischemic attacks in a community. Rochester, Minnesota, 1955 through 1969. Mayo Clin Proc. 1973 Mar;48(3):194-8. No abstract available.

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ReferenceCitation: Putman SF, Adams HP Jr. Usefulness of heparin in initial management of patients with recent transient ischemic attacks. Arch Neurol. 1985 Oct;42(10):960-2. doi: 10.1001/archneur.1985.04060090042011.

ReferenceCitation: Biller J, Bruno A, Adams HP Jr, Godersky JC, Loftus CM, Mitchell VL, Banwart KJ, Jones MP. A randomized trial of aspirin or heparin in hospitalized patients with recent transient ischemic attacks. A pilot study. Stroke. 1989 Apr;20(4):441-7. doi: 10.1161/01.str.20.4.441.

ReferenceCitation: Dennis M, Bamford J, Sandercock P, Warlow C. Prognosis of transient ischemic attacks in the Oxfordshire Community Stroke Project. Stroke. 1990 Jun;21(6):848-53. doi: 10.1161/01.str.21.6.848.

ReferenceCitation: Coull AJ, Lovett JK, Rothwell PM; Oxford Vascular Study. Population based study of early risk of stroke after transient ischaemic attack or minor stroke: implications for public education and organisation of services. BMJ. 2004 Feb 7;328(7435):326. doi: 10.1136/bmj.37991.635266.44. Epub 2004 Jan 26.

ReferenceCitation: Daffertshofer M, Mielke O, Pullwitt A, Felsenstein M, Hennerici M. Transient ischemic attacks are more than "ministrokes". Stroke. 2004 Nov;35(11):2453-8. doi: 10.1161/01.STR.0000144050.90132.8e. Epub 2004 Oct 14.

ReferenceCitation: Whitehead MA, McManus J, McAlpine C, Langhorne P. Early recurrence of cerebrovascular events after transient ischaemic attack. Stroke. 2005 Jan;36(1):1; author reply 1. doi: 10.1161/01.str.0000149929.92356.f1. No abstract available.

ReferenceCitation: Correia M, Silva MR, Magalhaes R, Guimaraes L, Silva MC. Transient ischemic attacks in rural and urban northern Portugal: incidence and short-term prognosis. Stroke. 2006 Jan;37(1):50-5. doi: 10.1161/01.STR.0000195209.26543.8f. Epub 2005 Dec 1.

ReferenceCitation: Purroy F, Molina CA, Montaner J, Alvarez-Sabin J. Absence of usefulness of ABCD score in the early risk of stroke of transient ischemic attack patients. Stroke. 2007 Mar;38(3):855-6; author reply 857. doi: 10.1161/01.STR.0000257306.00512.d3. Epub 2007 Jan 18. No abstract available.

ReferenceCitation: Wang Y, Johnston SC; CHANCE Investigators. Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event. Am Heart J. 2010 Sep;160(3):380-386.e1. doi: 10.1016/j.ahj.2010.05.017.

ReferenceCitation: Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.

ReferenceCitation: Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.

ReferenceCitation: Mac Grory B, Piccini JP, Yaghi S, Poli S, De Havenon A, Rostanski SK, Weiss M, Xian Y, Johnston SC, Feng W. Hyperglycemia, Risk of Subsequent Stroke, and Efficacy of Dual Antiplatelet Therapy: A Post Hoc Analysis of the POINT Trial. J Am Heart Assoc. 2022 Feb;11(3):e023223. doi: 10.1161/JAHA.121.023223. Epub 2022 Jan 19.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Meschia JF, Walton RL, Farrugia LP, Ross OA, Elm JJ, Farrant M, Meurer WJ, Lindblad AS, Barsan W, Ching M, Gentile N, Ross M, Nahab F, Easton JD, Kim AS, Zurita KG, Cucchiara B, Johnston SC. Efficacy of Clopidogrel for Prevention of Stroke Based on CYP2C19 Allele Status in the POINT Trial. Stroke. 2020 Jul;51(7):2058-2065. doi: 10.1161/STROKEAHA.119.028713. Epub 2020 Jun 17.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

repositories_institution: California Digital Library - eScholarship

unpaywall_oa_status: bronze

ReferenceCitation: Kamel H, Zhang C, Kleindorfer DO, Levitan EB, Howard VJ, Howard G, Soliman EZ, Johnston SC. Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack: Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):601-605. doi: 10.1001/jamaneurol.2020.0010.

ReferenceCitation: Cucchiara B, Elm J, Easton JD, Coutts SB, Willey JZ, Biros MH, Ross MA, Johnston SC. Disability After Minor Stroke and Transient Ischemic Attack in the POINT Trial. Stroke. 2020 Mar;51(3):792-799. doi: 10.1161/STROKEAHA.119.027465. Epub 2020 Feb 12.

ReferenceCitation: Farrant M, Easton JD, Adelman EE, Cucchiara BL, Barsan WG, Tillman HJ, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Zhao W, Pauls K, Walsh KB, Marti-Fabregas J, Bernstein RA, Johnston SC. Assessment of the End Point Adjudication Process on the Results of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: A Secondary Analysis. JAMA Netw Open. 2019 Sep 4;2(9):e1910769. doi: 10.1001/jamanetworkopen.2019.10769.

ReferenceCitation: Johnston SC, Elm JJ, Easton JD, Farrant M, Barsan WG, Kim AS, Lindblad AS, Palesch YY, Zurita KG, Albers GW, Cucchiara BL, Kleindorfer DO, Lutsep HL, Pearson C, Sethi P, Vora N; POINT and Neurological Emergencies Treatment Trials Network Investigators. Time Course for Benefit and Risk of Clopidogrel and Aspirin After Acute Transient Ischemic Attack and Minor Ischemic Stroke. Circulation. 2019 Aug 20;140(8):658-664. doi: 10.1161/CIRCULATIONAHA.119.040713. Epub 2019 Jun 26.

ReferenceCitation: Tillman H, Johnston SC, Farrant M, Barsan W, Elm JJ, Kim AS, Lindblad AS, Palesch YY, Easton JD. Risk for Major Hemorrhages in Patients Receiving Clopidogrel and Aspirin Compared With Aspirin Alone After Transient Ischemic Attack or Minor Ischemic Stroke: A Secondary Analysis of the POINT Randomized Clinical Trial. JAMA Neurol. 2019 Jul 1;76(7):774-782. doi: 10.1001/jamaneurol.2019.0932.

ReferenceCitation: Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.

repository_institution: West Virginia University - The Research Repository @ WVU

repositories_institution: West Virginia University - The Research Repository @ WVU

ReferenceCitation: Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.

ReferenceCitation: Johnston SC, Easton JD, Farrant M, Barsan W, Battenhouse H, Conwit R, Dillon C, Elm J, Lindblad A, Morgenstern L, Poisson SN, Palesch Y. Platelet-oriented inhibition in new TIA and minor ischemic stroke (POINT) trial: rationale and design. Int J Stroke. 2013 Aug;8(6):479-83. doi: 10.1111/ijs.12129.

repositories_institution:
PubMed Central - Europe PMC
University of Michigan - Deep Blue

collaborators: Neurological Emergencies Treatment Trials Network (NETT)

sponsor_collaborators: Neurological Emergencies Treatment Trials Network (NETT)

location_country:
Finland
Germany
New Zealand
United Kingdom
Australia
Mexico
United States
Spain
Canada
France

location_facility: University of Minnesota Medical Center Hospital

location_facility: Henrico Doctors' Hospital - Forest Campus

location_facility: Pennsylvania State Hershey Medical Center

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Valley Baptist Medical Center - Harlingen

location_facility: Oregon Health and Science University Hospital

location_facility: Lincoln Medical and Mental Health Center

location_facility: Southern Illinois University Memorial Medical Center

location_facility: University of Calgary - Foothills Campus

location_facility: Adolphe de Rothschild Ophthalmologic Foundation

location_facility: Mexican Association for Clinical Research

location_facility: Henrico Doctors' Hospital - Parham Campus

location_facility: Great Falls Clinic Hospital, Great Falls

location_facility: Banner University Medical Center - Tucson Campus

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital of the University of Pennsylvania

location_facility: UCSD Medical Center - Hillcrest Hospital

location_facility: Texas Health Presbyterian Hospital - Dallas

location_facility: Central Hospital Dr. Ignacio Morones Prieto

location_facility: University of Texas Health Science Center San Antonio

location_facility: New York Presbyterian / Columbia University Medical Center

location_facility: Medical University of South Carolina University Hospital

location_facility: University Hospital Schleswig-Holstein Kiel Campus


summary: This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients < 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.

ReferenceCitation: Malattia C, Ruperto N, Pederzoli S, Palmisani E, Pistorio A, Wouters C, Dolezalova P, Flato B, Garay S, Giancane G, Wells C, Douglass W, Brunner HI, De Benedetti F, Ravelli A; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Tocilizumab may slow radiographic progression in patients with systemic or polyarticular-course juvenile idiopathic arthritis: post hoc radiographic analysis from two randomized controlled trials. Arthritis Res Ther. 2020 Sep 10;22(1):211. doi: 10.1186/s13075-020-02303-y.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Oslo - Duo Research Archive

repositories:
LIRIAS (KU Leuven)
PubMed Central
www.duo.uio.no

repositories_concat: LIRIAS (KU Leuven);PubMed Central;www.duo.uio.no

ReferenceCitation: Pardeo M, Wang J, Ruperto N, Alexeeva E, Chasnyk V, Schneider R, Horneff G, Huppertz HI, Minden K, Onel K, Zemel L, Martin A, Kone-Paut I, Siamopoulou-Mavridou A, Silva CA, Porter-Brown B, Bharucha KN, Brunner HI, De Benedetti F; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Neutropenia During Tocilizumab Treatment Is Not Associated with Infection Risk in Systemic or Polyarticular-course Juvenile Idiopathic Arthritis. J Rheumatol. 2019 Sep;46(9):1117-1126. doi: 10.3899/jrheum.180795. Epub 2019 Mar 1.

oa_host_type: publisher

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Brunner HI, Ruperto N, Zuber Z, Keane C, Harari O, Kenwright A, Lu P, Cuttica R, Keltsev V, Xavier RM, Calvo I, Nikishina I, Rubio-Perez N, Alexeeva E, Chasnyk V, Horneff G, Opoka-Winiarska V, Quartier P, Silva CA, Silverman E, Spindler A, Baildam E, Gamir ML, Martin A, Rietschel C, Siri D, Smolewska E, Lovell D, Martini A, De Benedetti F; Paediatric Rheumatology International Trials Organisation PRINTO; Pediatric Rheumatology Collaborative Study Group (PRCSG). Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial. Ann Rheum Dis. 2015 Jun;74(6):1110-7. doi: 10.1136/annrheumdis-2014-205351. Epub 2014 May 16.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

endpoint_id: ebkqzhfrceygztdsjokh

repository_institution: University of Padua - Padua Research Archive

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: AECID Library - Americanae

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repositories_concat: LIRIAS (KU Leuven);PubMed Central;americanae.aecid.es;dnet;www.research.unipd.it

unpaywall_oa_status: hybrid

location_facility: Hospital Universitario Pedro Ernesto; Nucleo de Estudos da Saude do Adolescente

location_facility: Cincinnati Children'S Hospital Medical Center; Division of Rheumatology

location_facility: Clinica San Borja; Servicio De Reumatologia

location_facility: Asklepios Klinik; Zentrum fuer Allgemeine Paediatrie und Neonatologie

location_facility: Wojewodzki Specjalistyczny Szpital Dzieciecy Sw Ludwika; Oddzial Dzieci Starszych

location_facility: Clinica San Felipe; Consultorio de Reumatología

location_facility: Nuovo Ospedale Pediatrico Meyer; Reumatologia - Clinica Pediatrica 1°

location_facility: Centrum Pediatrii im Jana Pawla II; Oddzial Reumatologiczny

location_facility: Royal Liverpool Childrens Hospital; Rheumatology

location_facility: Children's National Medical Center; Pediatric Rheumatology

location_facility: University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit

location_facility: Princess Margaret Children'S Hospital; Department of Immunology

location_facility: Klinik Bremen-Mitte; Prof. Hess-Kinderklinik

location_facility: Hopitaux De Brabois; Medecine Infantile II

location_facility: Hospital Universitario Virgen Macarena; Servicio de Reumatologia

location_facility: Univ. Di Padova - Dip. Di Pediatria - Unita' Reumatol. Pediatrica

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: ASST CENTRO SPECIALISTICO ORTOPEDICO TRAUMATO-LOGICO GAETANO PINI/CTO; Reumatol. Pediatrica

location_facility: Instituto de Puericultura E Pediatria Martagão Gesteira

location_facility: Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Reumatologia

location_facility: Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

location_facility: Centro Medico Privado de Reumatologia; Reumathology

location_facility: Saint-Petersburg State; Pediatrics Medical Academy

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: Connecticut Children's Medical Center; 5E Clinical Trials Unit

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher

location_facility: I. M. Sechenov Moscow State Medical University; The Ministry of Health and Social Development of RF

location_facility: Samara Regional Clinical Cardiology Dispensary

location_facility: Uniwersytecki Szpital Kliniczny Nr 4 im. M. Konopnickiej; Oddz. Kardiolog. i Reumatolog. dla Dzieci

location_facility: Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina

location_facility: Hackensack University Medical Center; Pediatric Rheumatology

location_facility: Great Ormond Street Hospital for Sick Children; Institute of Child Health

location_facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

location_facility: British Columbia Children's Hospital; Rheumatology

location_facility: Southern District Medical Center of Roszdrav

location_facility: Dzieciecy Szpital Kliniczny IM. Prof. A. Gebali; Oddzial Pediatrii Chorob Pluc I Reumatologii

location_facility: Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen

location_facility: The University of Chicago;Department of Pediatrics

location_facility: Hôpital Pellegrin; Urgences Pédiatriques

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: Clementine Hospital; Kinder- und Jugendrheumatologie

location_facility: Wojewodzki Szpital Dzieciecy Im. J. Brudzinskiego

location_facility: SI Sceintific children health center RAMS

location_facility: Royal Children'S Hospital; Paediatric Rheumatology

location_facility: Westmead Hospital; Paediatric Rheumatology

title: A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Brazil
Mexico
Belgium
United States
Spain
Peru
Canada
Russian Federation
France


lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

summary: The purpose of this study is to make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.

location_facility:
Teva Investigational Site 3138
Teva Investigational Site 5900
Teva Investigational Site 1085
Teva Investigational Site 3144
Teva Investigational Site 5023
Teva Investigational Site 3038
Teva Investigational Site 5705
Teva Investigational Site 6100
Teva Investigational Site 3248
Teva Investigational Site 3424
Teva Investigational Site 3809
Teva Investigational Site 5022
Teva Investigational Site 5901
Teva Investigational Site 1075
Teva Investigational Site 3140
Teva Investigational Site 5704
Teva Investigational Site 1131
Teva Investigational Site 8033
Teva Investigational Site 3146
Teva Investigational Site 3241
Teva Investigational Site 1134
Teva Investigational Site 5319
Teva Investigational Site 5802
Teva Investigational Site 5026
Teva Investigational Site 5211
Teva Investigational Site 1097
Teva Investigational Site 1102
Teva Investigational Site 5317
Teva Investigational Site 3526
Teva Investigational Site 3046
Teva Investigational Site 1092
Teva Investigational Site 5114
Teva Investigational Site 1076
Teva Investigational Site 5208
Teva Investigational Site 3132
Teva Investigational Site 3525
Teva Investigational Site 1078
Teva Investigational Site 3238
Teva Investigational Site 5416
Teva Investigational Site 1098
Teva Investigational Site 3243
Teva Investigational Site 5320
Teva Investigational Site 3237
Teva Investigational Site 5209
Teva Investigational Site 5504
Teva Investigational Site 5027
Teva Investigational Site 3143
Teva Investigational Site 3303
Teva Investigational Site 3246
Teva Investigational Site 1088
Teva Investigational Site 3249
Teva Investigational Site 3044
Teva Investigational Site 8030
Teva Investigational Site 3139
Teva Investigational Site 1090
Teva Investigational Site 1130
Teva Investigational Site 5030
Teva Investigational Site 1083
Teva Investigational Site 8032
Teva Investigational Site 3524
Teva Investigational Site 8031
Teva Investigational Site 5505
Teva Investigational Site 3142
Teva Investigational Site 5315
Teva Investigational Site 3136
Teva Investigational Site 6102
Teva Investigational Site 3528
Teva Investigational Site 5212
Teva Investigational Site 1073
Teva Investigational Site 1093
Teva Investigational Site 3425
Teva Investigational Site 5316
Teva Investigational Site 3137
Teva Investigational Site 5024
Teva Investigational Site 1126
Teva Investigational Site 3134
Teva Investigational Site 3236
Teva Investigational Site 5318
Teva Investigational Site 3135
Teva Investigational Site 5116
Teva Investigational Site 5801
Teva Investigational Site 1086
Teva Investigational Site 5210
Teva Investigational Site 3300
Teva Investigational Site 5903
Teva Investigational Site 1096
Teva Investigational Site 5325
Teva Investigational Site 3242
Teva Investigational Site 5417
Teva Investigational Site 4204
Teva Investigational Site 5804
Teva Investigational Site 4206
Teva Investigational Site 3041
Teva Investigational Site 5904
Teva Investigational Site 5021
Teva Investigational Site 5905
Teva Investigational Site 5803
Teva Investigational Site 5117
Teva Investigational Site 5322
Teva Investigational Site 4205
Teva Investigational Site 8100
Teva Investigational Site 1100
Teva Investigational Site 3302
Teva Investigational Site 5029
Teva Investigational Site 3250
Teva Investigational Site 8201
Teva Investigational Site 5800
Teva Investigational Site 1132
Teva Investigational Site 3040
Teva Investigational Site 8101
Teva Investigational Site 3251
Teva Investigational Site 3042
Teva Investigational Site 1101
Teva Investigational Site 3039
Teva Investigational Site 1082
Teva Investigational Site 1084
Teva Investigational Site 3245
Teva Investigational Site 3133
Teva Investigational Site 3810
Teva Investigational Site 3045
Teva Investigational Site 3247
Teva Investigational Site 1129
Teva Investigational Site 3527
Teva Investigational Site 1081
Teva Investigational Site 3422
Teva Investigational Site 555
Teva Investigational Site 5902
Teva Investigational Site 5115
Teva Investigational Site 5028
Teva Investigational Site 3240
Teva Investigational Site 3239
Teva Investigational Site 1128
Teva Investigational Site 5025
Teva Investigational Site 3244
Teva Investigational Site 3529

title: A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MS

location_country:
Germany
Poland
Turkey
Czechia
Canada
Serbia
France
Lithuania
Hungary
United States
Ukraine
Romania
Estonia
Italy
United Kingdom
Sweden
Netherlands
Austria
Spain
Bulgaria
Georgia
Russian Federation
Israel

status_simplified: Unknown


lead_sponsor: Boehringer Ingelheim

summary: To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1

ReferenceCitation: Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Bocher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon alpha-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7.

publisher_dissemination: American Society for Microbiology

location_facility: 1220.40.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4909 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1001 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3305A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4001 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3302A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1005 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3303A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.004 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1004 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3306A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4303 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.002 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.40.006 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.007 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.4003 Boehringer Ingelheim Investigational Site

location_facility: 1220.40.005 Boehringer Ingelheim Investigational Site

title: Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)

location_country:
Germany
Romania
Austria
United States
Canada
France


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

summary: The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)

ReferenceCitation: Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.

evidence: oa journal (via publisher name)

publisher_dissemination: Hindawi

ReferenceCitation: Giuliano F, Oelke M, Jungwirth A, Hatzimouratidis K, Watts S, Cox D, Viktrup L. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med. 2013 Mar;10(3):857-65. doi: 10.1111/jsm.12039. Epub 2013 Jan 24.

publisher_dissemination: Oxford University Press

ReferenceCitation: Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol. 2012 May;61(5):917-25. doi: 10.1016/j.eururo.2012.01.013. Epub 2012 Jan 20.

location_country: Germany Italy Poland Australia Netherlands Austria Belgium Mexico Greece France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

summary: This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

ReferenceCitation: Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.

ReferenceCitation: Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

ReferenceCitation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.

ReferenceCitation: Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

evidence: open (via crossref license)

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.

ReferenceCitation: Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.

ReferenceCitation: Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

ReferenceCitation: Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum In: Ann Rheum Dis. 2017 Mar;76(3):611.

ReferenceCitation: Strand V, Burmester GR, Zerbini CA, Mebus CA, Zwillich SH, Gruben D, Wallenstein GV. Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial. Arthritis Care Res (Hoboken). 2015 Apr;67(4):475-83. doi: 10.1002/acr.22453.

ReferenceCitation: Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

ReferenceCitation: Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C; ORAL Step investigators. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. 2013 Feb 9;381(9865):451-60. doi: 10.1016/S0140-6736(12)61424-X. Epub 2013 Jan 5.

location_country:
Germany
Ireland
Italy
Australia
Brazil
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Puerto Rico
France


title: A Randomised, Open-label, Multi-centre, 2-stage, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC) in Comparison With LDAC Alone in Patients Aged ≥ 60 With Newly Diagnosed Acute Myeloid Leukaemia (AML)

summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

ReferenceCitation: Quintas-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
United Kingdom
Romania
Australia
Japan
United States
Spain
France


title: A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

ReferenceCitation: van Lunzen J, Maggiolo F, Arribas JR, Rakhmanova A, Yeni P, Young B, Rockstroh JK, Almond S, Song I, Brothers C, Min S. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial. Lancet Infect Dis. 2012 Feb;12(2):111-8. doi: 10.1016/S1473-3099(11)70290-0. Epub 2011 Oct 20.

lead_sponsor: ViiV Healthcare

collaborators: Shionogi GlaxoSmithKline

sponsor_collaborators:
ViiV Healthcare
Shionogi
GlaxoSmithKline

location_country:
Germany
Italy
United States
Spain
Russian Federation
France


title: Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled

acronym: LANCELOT

summary:
Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

Plasma glucose (fasting, nocturnal) over time,
Changes from baseline in HbA1c over time,
Percentage of patients who reach the target of HbA1c <7 and <6.5,
Use of prandial insulin as rescue medication at month 6,
Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
Daily dose of insulin,
Change in body weight from baseline,
Evolution of 8-point plasma-glucose (PG) profiles,
Overall safety,
Patient reported outcomes (treatment satisfaction).

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

publisher_dissemination: Wiley

ReferenceCitation: Home PD, Bolli GB, Mathieu C, Deerochanawong C, Landgraf W, Candelas C, Pilorget V, Dain MP, Riddle MC. Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naive people with type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):15-22. doi: 10.1111/dom.12329. Epub 2014 Jul 12.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

lead_sponsor: Sanofi

location_country:
Italy
Poland
Russian Federation
Slovakia
Romania
Kuwait
Brazil
Netherlands
Mexico
Sweden
Switzerland
Korea, Republic of
Thailand
United Arab Emirates
Czech Republic
Egypt
France

location_facility:
Investigational Site Number 410004
Investigational Site Number 764004
Investigational Site Number 410006
Investigational Site Number 703002
Investigational Site Number 764002
Investigational Site Number 250-003
Investigational Site Number 203008
Investigational Site Number 528005
Investigational Site Number 250-006
Investigational Site Number 642003
Investigational Site Number 250-005
Investigational Site Number 703006
Investigational Site Number 203002
Investigational Site Number 642009
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Investigational Site Number 818001
Investigational Site Number 616003
Investigational Site Number 643-005
Investigational Site Number 703007
Investigational Site Number 756001
Investigational Site Number 784-001
Investigational Site Number 703008
Investigational Site Number 484005
Investigational Site Number 203005
Investigational Site Number 484001
Investigational Site Number 250-004
Investigational Site Number 076-007
Investigational Site Number 076-003
Investigational Site Number 410002
Investigational Site Number 703005
Investigational Site Number 410005
Investigational Site Number 410003
Investigational Site Number 643-003
Investigational Site Number 703001
Investigational Site Number 642007
Investigational Site Number 616002
Investigational Site Number 642011
Investigational Site Number 752004
Investigational Site Number 642002
Investigational Site Number 203007
Investigational Site Number 642001
Investigational Site Number 642012
Investigational Site Number 203004
Investigational Site Number 764006
Investigational Site Number 203006
Investigational Site Number 414001
Investigational Site Number 076-005
Investigational Site Number 484009
Investigational Site Number 484003
Investigational Site Number 642005
Investigational Site Number 764003
Investigational Site Number 642004
Investigational Site Number 528004
Investigational Site Number 203011
Investigational Site Number 528001
Investigational Site Number 752003
Investigational Site Number 752002
Investigational Site Number 703004
Investigational Site Number 703003
Investigational Site Number 484008
Investigational Site Number 643-002
Investigational Site Number 643-004
Investigational Site Number 484002
Investigational Site Number 076-006
Investigational Site Number 203010
Investigational Site Number 203001
Investigational Site Number 203009
Investigational Site Number 616004
Investigational Site Number 616001
Investigational Site Number 250-001
Investigational Site Number 076-004
Investigational Site Number 642008
Investigational Site Number 380001
Investigational Site Number 250-002
Investigational Site Number 528002
Investigational Site Number 528003
Investigational Site Number 643-006
Investigational Site Number 076-001
Investigational Site Number 764001
Investigational Site Number 076-002
Investigational Site Number 642010
Investigational Site Number 643-007
Investigational Site Number 643-001
Investigational Site Number 752001
Investigational Site Number 410001


title: A Multi-center, Randomized, Open Label, Controlled Study to Compare the Sustained Virological Response During Treatment With Neoral or Tacrolimus in Maintenance Liver Transplant Recipients Treated With Pegylated Interferon and Ribavirin for Recurrent Hepatitis C

acronym: SUSTAIN

summary: This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Colombia
United Kingdom
Brazil
Switzerland
Belgium
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


acronym: GALACCTIC

lead_sponsor: Astellas Pharma Inc

summary: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens

ReferenceCitation: Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. doi: 10.1016/S1470-2045(15)70081-1. Epub 2015 Mar 18.

repository_institution: University of Turin - Institutional Research Information System University of Turin

location_facility: Royal North Shore Hospital Department of Endocrinology

location_facility: CHRU Lille, Clinique Endocrinologique Marc Linquette

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach

location_facility: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: University of Colorado Denver Cancer Center

location_facility: TGen Clinical Research Service at Scottsdale Healthcare

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Netherlands
United States
Canada
France


title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

summary: The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

ipd_sharing: No

lead_sponsor: MacroGenics

sponsor_collaborators:
MacroGenics
Eli Lilly and Company

location_country:
Finland
Germany
Italy
Poland
India
Israel
United Kingdom
Romania
Netherlands
Mexico
Belgium
United States
Spain
Czechia
Ukraine
France

location_facility: Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism

location_facility: The Safra Children's Hospital, The Chaim Sheba Medical Center

location_facility: Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4

location_facility: Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd.

location_facility: Institutul National De Diabet, Nutritie si Boli Metabolice

location_facility: Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Diabetes and Glandular Disease Research Associates, PA

location_facility: CHU de Brest Hôpital de la Cavale Blanche

location_facility: Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: Klinika deti a dorostu FN Kralovske Vinohrady

location_facility: Hospital y Clinica OCA / Monterrey International Research Center

location_facility: John H Stoger Jr. Hospital of Cook County, Cook County Hospital

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital Civil

location_facility: Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia

location_facility: B. P. Poddar Hospital & Medical Research Limited

location_facility: Children's Hospitals and Clinics of Minnesota

location_facility: Ukrainian Children Specialized Clinical Hospital

location_facility: Regional Clinical Endocrinology Dispensary of MoH Ukraine

location_facility: Donetsk Regional Children Clinical Hospital

location_facility: Herz und Diabeteszentrum Nordrhein-Westfallen

location_facility: Maulana Azad Medical College and Associated Hospitals

location_facility: Queens Medical Centre, Diabetes and Endocrinology Unit

location_facility: East Carolina University, Brody School of Medicine

location_facility: Clinical Innovations Inc. Research Facility

location_facility: Sheffield Children's Hospital NHS Foundation Trust

location_facility: U.O. di Malattie Metaboliche e Diabetologia

location_facility: Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu

location_facility: Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.

location_facility: University Diabetes & Endocrine Consultants

location_facility: University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology

location_facility: Kharkiv Regional Clinical Children Hospital, Department of Endocrinology

location_facility: Centrum diabetologie, Institut klinicke a experimentalni mediciny

location_facility: Ivano-Frankivsk State Regional Pediatric Clinical Hospital

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Maryland Diabetes & Endocrine Associates

location_facility: Wojewódzki Specjalistyczny Szpital Dzieciecy

location_facility: University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Hospital Universitario Principe de Asturias

location_facility: I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice


title: A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.

summary: The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

enrollment_type: Anticipated

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

ReferenceCitation: Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

ReferenceCitation: Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Kirson ED, Schneiderman RS, Dbaly V, Tovarys F, Vymazal J, Itzhaki A, Mordechovich D, Gurvich Z, Shmueli E, Goldsher D, Wasserman Y, Palti Y. Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). BMC Med Phys. 2009 Jan 8;9:1. doi: 10.1186/1756-6649-9-1.

ReferenceCitation: Ram Z, Kim CY, Hottinger AF, Idbaih A, Nicholas G, Zhu JJ. Efficacy and Safety of Tumor Treating Fields (TTFields) in Elderly Patients with Newly Diagnosed Glioblastoma: Subgroup Analysis of the Phase 3 EF-14 Clinical Trial. Front Oncol. 2021 Sep 27;11:671972. doi: 10.3389/fonc.2021.671972. eCollection 2021. Erratum In: Front Oncol. 2022 Apr 12;12:902929.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Université de Lausanne - SERVAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories:
HAL
PubMed Central
serval.unil.ch

repositories_concat: HAL;PubMed Central;serval.unil.ch

publisher_dissemination: Frontiers

ReferenceCitation: Kim CY, Paek SH, Nam DH, Chang JH, Hong YK, Kim JH, Kim OL, Kim SH. Tumor treating fields plus temozolomide for newly diagnosed glioblastoma: a sub-group analysis of Korean patients in the EF-14 phase 3 trial. J Neurooncol. 2020 Feb;146(3):399-406. doi: 10.1007/s11060-019-03361-2. Epub 2020 Feb 4.

ReferenceCitation: Ballo MT, Urman N, Lavy-Shahaf G, Grewal J, Bomzon Z, Toms S. Correlation of Tumor Treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1106-1113. doi: 10.1016/j.ijrobp.2019.04.008. Epub 2019 Apr 23.

ReferenceCitation: Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019 Jan;141(2):467-473. doi: 10.1007/s11060-018-03057-z. Epub 2018 Dec 1.

ReferenceCitation: Taphoorn MJB, Dirven L, Kanner AA, Lavy-Shahaf G, Weinberg U, Taillibert S, Toms SA, Honnorat J, Chen TC, Sroubek J, David C, Idbaih A, Easaw JC, Kim CY, Bruna J, Hottinger AF, Kew Y, Roth P, Desai R, Villano JL, Kirson ED, Ram Z, Stupp R. Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):495-504. doi: 10.1001/jamaoncol.2017.5082.

ReferenceCitation: Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum In: JAMA. 2018 May 1;319(17):1824.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Kesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.

ReferenceCitation: Meletath SK, Pavlick D, Brennan T, Hamilton R, Chmielecki J, Elvin JA, Palma N, Ross JS, Miller VA, Stephens PJ, Snipes G, Rajaram V, Ali SM, Melguizo-Gavilanes I. Personalized Treatment for a Patient With a BRAF V600E Mutation Using Dabrafenib and a Tumor Treatment Fields Device in a High-Grade Glioma Arising From Ganglioglioma. J Natl Compr Canc Netw. 2016 Nov;14(11):1345-1350. doi: 10.6004/jnccn.2016.0145.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

location_country:
Germany
Italy
Israel
Sweden
Switzerland
Austria
United States
Korea, Republic of
Spain
Canada
Czech Republic
France

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Az. Ospedaliero-Universitaria - Ospedali Riuniti

location_facility: Hôpital Saint André Centre Hospitalier Universitaire (CHU) des Hôpitaux de Bordeaux

location_facility: Seoul National University Hospital (SNUH)

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University Hospital of Schleswig-Holstein

location_facility: Hospital 12 de Octubre, Servicio de Oncología Médica

location_facility: The University of Texas Health Science Center at Houston (UTHSC)

location_facility: Centre Hospitalo-Universitaire de Toulouse Purpan

location_facility: Washington University School of Medicine, Division of Oncology

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute

location_facility: New Jersey Neuroscience Center - JFK Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of California San Diego Moores Cancer Center (UCSD)

location_facility: Mount Sinai Medical Center, Department of Neurosurgery

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Seoul National University Bundang Hospital (SNUBH)

location_facility: Emory University, Winship Cancer Institute

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: McGill - Gerald Bronfman Centre for Clinical Research in Oncology -

location_facility: Hospital Universitari de Bellvitge-ICO Duran i Reynals

location_facility: Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Yonsei University Severance Hospital (YUHS)

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital (CMC Seoul)

location_facility: UF Health Cancer Center at Orlando Health

location_facility: (CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie

location_facility: Hospital of the University of Pennsylvania

location_facility: Chungnam National University Hospital (CNUH)

location_facility: University of Kentucky, Markey Cancer Center


acronym: ORIGIN

summary: The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.

ReferenceCitation: Chanan-Khan A, Egyed M, Robak T, Martinelli de Oliveira FA, Echeveste MA, Dolan S, Desjardins P, Blonski JZ, Mei J, Golany N, Zhang J, Gribben JG. Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial). Leukemia. 2017 May;31(5):1240-1243. doi: 10.1038/leu.2017.47. Epub 2017 Jan 31. No abstract available.

repository_institution: PubMed Central - Europe PMC

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Pro Onco Centro de Tratamento Oncologico

location_facility: GUZ Nizhegorodskaya Regional Clinical Hospital

location_facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: Herlev University Hospital Dep of hematology

location_facility: Instituto Clinico Oncologico del Sur ICOS

location_facility: BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A

location_facility: University hospital Sveti Georgi Hematology Clinic

location_facility: Fundação Antonio Prudente - AC Camargo Câncer center

location_facility: GUS Leningrad Regional Clinical Hospital

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Central Texas Veterans Health Care System

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Russian Academy of Medical Sciences Institution

location_facility: National Specialized Hospital for Active Treatment of Hematology Diseases

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: MHAT Georgi Stranski PlevenHematology Clinic

location_facility: St. Bartholomew's and The Royal London Hospital

location_facility: Hospital General Universitario Morales Messeguer

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Klinika Chorob wewnetrznych i Hematologii

location_facility: Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Instituto de Ensino e Pesquisa Sao Lucas

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

location_facility: Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

location_facility: Szegedi TudomanyegyetemII Belgyogyaszati Klinika

location_facility: Specjalistyczny Szpital miejski im. Kopernika

location_facility: Regional Health Authority B-Saint John Regional Hospital

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Medical University of Vienna Internalmedicine 1, Hematology

location_facility: Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju

location_facility: Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC

location_facility: Instituto Portugues Oncologia do Porto Francisco Gentil EPE

location_facility: Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO

title: A Phase 3, Multicenter, Randomized, Openlabel, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) Versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia (The Origin Trial)

location_country:
Poland
New Zealand
Australia
Brazil
Croatia
Chile
Czechia
Canada
Serbia
France
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
South Africa
Bulgaria
Russian Federation
Israel


title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

summary: A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

ReferenceCitation: Wolpin BM, O'Reilly EM, Ko YJ, Blaszkowsky LS, Rarick M, Rocha-Lima CM, Ritch P, Chan E, Spratlin J, Macarulla T, McWhirter E, Pezet D, Lichinitser M, Roman L, Hartford A, Morrison K, Jackson L, Vincent M, Reyno L, Hidalgo M. Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. Ann Oncol. 2013 Jul;24(7):1792-1801. doi: 10.1093/annonc/mdt066. Epub 2013 Feb 28.

sponsor_collaborators:
Astellas Pharma Inc
Agensys, Inc.

location_country:
United States
Spain
Canada
Russian Federation
France

location_facility: State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"

location_facility: University of California San Diego Medical Center

location_facility: State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"

location_facility: Kaiser Permanente Northwest Region Oncology Hematology

location_facility: Centre Régional de Lutte Contre le Cancer-Centre Oscar Lambret

location_facility: Clinical Oncology Dispensary of Republic of Tatarstan

location_facility: Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia

location_facility: Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic

location_facility: Vanderbilt University Medical Center, Div. of Medical Oncology

location_facility: State Healthcare Institution "Leningrad Regional Oncologic Dispensary"

location_facility: Medical Radiology Research Center of Russian Medical Academy

location_facility: Hôpital du Haut Lèvêque, Service d'Hepato Gastroentérologie

location_facility: Palm Beach Institute of Hematology and Oncology

location_facility: Hospital Virgen de la Salud, Servicio Oncologia

location_facility: Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway"

location_facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Saint Petersburg State Healthcare Institution "Municipal Clinical Oncology Dispensary"

location_facility: Centre Hospitalier Universitaire de Poitiers

intervention_type: Biological


title: Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic NSCLC

summary: The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.

ReferenceCitation: Janne PA, Smith I, McWalter G, Mann H, Dougherty B, Walker J, Orr MC, Hodgson DR, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios CH, Franke FA, Crino L, Smith P. Impact of KRAS codon subtypes from a randomised phase II trial of selumetinib plus docetaxel in KRAS mutant advanced non-small-cell lung cancer. Br J Cancer. 2015 Jul 14;113(2):199-203. doi: 10.1038/bjc.2015.215. Epub 2015 Jun 30.

ReferenceCitation: Janne PA, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios C, Franke FA, Grinsted L, Zazulina V, Smith P, Smith I, Crino L. Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: a randomised, multicentre, placebo-controlled, phase 2 study. Lancet Oncol. 2013 Jan;14(1):38-47. doi: 10.1016/S1470-2045(12)70489-8. Epub 2012 Nov 28.

location_country:
Italy
Bulgaria
Hungary
Brazil
Mexico
Belgium
United States
Spain
Czechia
Canada
Peru
France


summary: The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.

ReferenceCitation: Farkkila M, Diener HC, Geraud G, Lainez M, Schoenen J, Harner N, Pilgrim A, Reuter U; COL MIG-202 study group. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012 May;11(5):405-13. doi: 10.1016/S1474-4422(12)70047-9. Epub 2012 Mar 28.

sponsor_collaborators:
Eli Lilly and Company
CoLucid Pharmaceuticals

title: A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country: Finland Germany Belgium Spain France


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone

ReferenceCitation: Trump D. Commentary on: "Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): A multicentre, randomised, double-blind, phase 3 trial." Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengelov L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR, CA184-043 Investigators. Departments of Urology and Immunology and Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, MN, USA, Electronic address: kwon.eugene@mayo.edu; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Brady Urological Institute, Baltimore, MD, USA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA; Institut Gustave Roussy, University of Paris-Sud, Villejuif, France; Institut Gustave Roussy, Villejuif, France; VU University Medical Centre, Amsterdam, Netherlands; Vienna General Hospital, Medical University Vienna, Vienna, Austria; Institut Bergonie, Bordeaux, France; CHU Caremeau, Nimes, France; Centro Medico Austral, Buenos Aires, Argentina; Centre Jean Perrin, Clermont-Ferrand, France; St John of God Hospital, Subiaco, WA, Australia; University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy; Hospital de Caridade de Ijui, Ijui, Brazil; Nottingham University Hospital, Nottingham, UK; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA; Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania; Hospital Britanico de Buenos Aires, Buenos Aires, Argentina; Herlev Hospital, Herlev, Denmark; Odense University Hospital, Odense, Denmark; University of Texas MD Anderson Cancer Center, Houston, Urol Oncol. 2016 May;34(5):249-50. doi: 10.1016/j.urolonc.2015.03.013. Epub 2015 Apr 20.

ReferenceCitation: Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengelov L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. doi: 10.1016/S1470-2045(14)70189-5. Epub 2014 May 13.

repositories_concat: PubMed Central;usiena-air.unisi.it

ReferenceCitation: Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13.

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: Associates In Hematology & Oncology, P.C.

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: St Johns Medical Research Institute, Inc.

location_facility: The Center For Cancer And Blood Disorders

location_facility: Mid-Illinois Hematology & Oncology Associates, Ltd

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: St. Luke'S Hospital & Health Network Laboratory

location_facility: Siouxland Hematology-Oncology Assoc., Llp

location_facility: Suburban Hematology-Oncology Associates, Pc

location_facility: The Bunting-Blaustein Cancer Research Building

location_facility: University Of Iowa Hospitals And Clinics

title: A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Czech Republic
Colombia
Hungary
Denmark
United States
Romania
Belgium
Peru
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Russian Federation
Israel


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia

acronym: COMORBID©

summary: Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

ReferenceCitation: Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.

ReferenceCitation: Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.

location_country:
Germany
Italy
Portugal
Mexico
United States
Greece
Canada
Russian Federation
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.