title: A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

summary: This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

ReferenceCitation: Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.

publisher_dissemination: Becaris Publishing Limited

ReferenceCitation: Chapple C, Schneider T, Haab F, Sun F, Whelan L, Scholfield D, Dragon E, Mangan E. Superiority of fesoterodine 8 mg vs 4 mg in reducing urgency urinary incontinence episodes in patients with overactive bladder: results of the randomised, double-blind, placebo-controlled EIGHT trial. BJU Int. 2014 Sep;114(3):418-26. doi: 10.1111/bju.12678. Epub 2014 Jul 1.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Poland
Argentina
Chile
Canada
France
Czech Republic
Lithuania
Colombia
Slovakia
Hungary
Denmark
United States
Ukraine
Philippines
Egypt
Italy
Norway
United Kingdom
Mexico
Korea, Republic of
Greece
South Africa
Taiwan
Russian Federation
Sweden

location_facility: Stanley Flax Medical Professional Corporation

location_facility: Hôpital CAREMEAU - Service Urologie/Andrologie

location_facility: MTPI "Central City Clinical Hospital #1"/Donetsk National Medical University n.a. M. Gorkiy,

location_facility: Taipei Veterans General Hospital/Division of Urology

location_facility: Klinische Forschung Hannover - Mitte GmbH

location_facility: ACRC Trials (Administrative/Mailing Site)

location_facility: Columbus Center for Women's Health Research

location_facility: Clinical Research Center of Cape Cod, Inc.

location_facility: Research Institute of Obstetrics and Gynaecology D.O. Otta of North-west Department of RAMS

location_facility: Jacksonville Center for Clinical Research

location_facility: Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education

location_facility: Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group

location_facility: Hospital Lomas de San Luis Internacional

location_facility: CRS Clinical Research Service Moenchengladbach GmbH

location_facility: Central Kentucky Research Associates, Inc.

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Department of Urology of Donetsk National Medical University at Central City Clinical Hospital #1

location_facility: Florida Sleep Disorder Center of Brandon

location_facility: Centrum urologie Povazska Bystrica, s.r.o. urologicka ambulancia

location_facility: Fleming Island Center for Clinical Research

location_facility: Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates

location_facility: GYNPOR SK, s.r.o. Urogynekologicka ambulancia

location_facility: Rostov State Medical University, Chair of Urology

location_facility: Department of Urology, Korea University Anam Hospital

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Montgomery Women's Health Associates, P.C.

location_facility: Roskilde sygehus, Gynaekologisk/obstetrisk afdeling

location_facility: Women's Healthcare Associates dba Rosemark WomenCare Specialists

location_facility: Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku

location_facility: Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly

location_facility: Women's and Family Care dba GTC Research

location_facility: Toronto Western Hospital, University Health Network

location_facility: Non-governmental Healthcare Institution Departmental Clinical Hospital at Barnaul station OAO RZD

location_facility: RMI "Chernivtsi Regional Clinical Hosp.", Dep. of Urology, BSMU, Chair of Surgery and Urology

location_facility: Vinnitsa Regional Clinical Dispensary of Endocrinology

location_facility: Cambridge University Hospital Trials NHS Trust

location_facility: Adams Patterson Gynocology and Obstetrics, PLLC

location_facility: City Hospital #4 of Donetsk, Woman Consultative Department

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Norsk Helseklinikk AS, c/o Heiaklinikken

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika

location_facility: Severance Hospital, Yonsei University College of Medicine, Department of Urology

location_facility: Medical Affiliated Research Center, Inc.

location_facility: Memorial Clinical Associates dba MCA Research

location_facility: The Office of Dr. Myron I. Murdock, MD, LLC

location_facility: Solano Y Terront Servicios Medicos Ltda / Unidad Integral de Endocrinologia Uniendo

location_facility: Asan Medical Center, Department of Urology

location_facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly

location_facility: Clinica Urologica Centro Trapianti di rene

location_facility: Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: FN a LFUK Hradec Kralove/Urologicka klinika

location_facility: Kvinnokliniken Karolinska Universitetssjukhuset Huddinge

location_facility: Nemocnica s Poliklinikou Svateho Lukasa Galanta

location_facility: Internal Medicine and Pediatric Associates of Bristol, PC

location_facility: Forusakutten AS, Avdeling for oppdragsforskning

location_facility: Wake Internal Medicine Consultants, Inc.

location_facility: University General Hospital of Larisa/ Urology Department

location_facility: Uzhorod City Outpatient Clinic, Prophylaxis Department

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital, Department of Urology

location_facility: Fundacion Centro de Investigacion Clinica CIC

location_facility: McMaster Institute of Urology, St Joseph's Healthcare Hamilton


type: EudraCT Number

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection

summary: Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Shaw M, Pediconi C, McVey D, Mondou E, Quinn J, Chamblin B, Rousseau F. Safety and efficacy of ulimorelin administered postoperatively to accelerate recovery of gastrointestinal motility following partial bowel resection: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2013 Jul;56(7):888-97. doi: 10.1097/DCR.0b013e31829196d0.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Tranzyme, Inc.

sponsor_collaborators:
Tranzyme, Inc.
Norgine

location_country:
Lithuania
Romania
United States
Bulgaria
Czech Republic
France

location_facility: Institute of Oncology at Vilnius University, Clinic of Surgery

location_facility: Institute regional de Gastroenterologie si Hepatologie

location_facility: Vilnius City Univ. Hospital Clinic of Surgery

location_facility: University of Iowa Hospitals and Clinics

location_facility: Texas Tech University Health Sciences Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A 6-month, Randomised, Double-blind, Parallel-group, Risperidone-controlled, Fixed-dose Study Evaluating the Safety and Efficacy of Zicronapine in Patients With Schizophrenia

summary: To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment.

lead_sponsor: H. Lundbeck A/S

location_country:
Finland
Poland
Estonia
Czech Republic
France


title: A Phase II, Single-arm Study of Orally Administered BKM120 as Second-line Therapy in Patients With Advanced Endometrial Carcinoma

summary: This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Poland
Singapore
Australia
Brazil
Japan
Belgium
United States
Spain
Canada
Russian Federation
France

location_facility: South Texas Oncology and Hematology, PA South Tex Onc

location_facility: University of Oklahoma Health Sciences Center OU Health

location_facility: Cancer Care Northwest CC Northwest- Spokane South(3)

location_facility: St. Joseph's Hospital & Medical Center St Joseph's

location_facility: Sarah Cannon Research Institute SCRI (2)

location_facility: Carolinas HealthCare Systems Blumenthal Cancer Center

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp


acronym: VISADO

lead_sponsor: Bayer

summary: A clinical trial which was designed to demonstrate the safety and efficacy of Visanne (approved in endometriosis for adults) in the adolescent population.

title: A Multi-center, Open Label, Single-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of 2 mg Dienogest Tablets for the Treatment of Endometriosis in Adolescents Over a Treatment Period of 52 Weeks

source: euctr

location_country:
Finland
Germany
Austria
Spain
Czech Republic
France


title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

summary: To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Khamashta M, Merrill JT, Werth VP, Furie R, Kalunian K, Illei GG, Drappa J, Wang L, Greth W; CD1067 study investigators. Sifalimumab, an anti-interferon-alpha monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Nov;75(11):1909-1916. doi: 10.1136/annrheumdis-2015-208562. Epub 2016 Mar 23.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.

publisher_dissemination: SAGE Publications

lead_sponsor: MedImmune LLC

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Chile
Canada
France
Hungary
United States
India
Romania
Peru
Philippines
Italy
Jamaica
United Kingdom
Netherlands
Mexico
Spain
South Africa
Bulgaria

intervention_type: Other


title: A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents

acronym: DELTA

summary:
The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy.

Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.

ReferenceType: result

ReferenceCitation: Salles GA, Kahl, BS, Wagner-Johnston ND, et al. Interim results from a phase 2 study of PI3Kδ inhibitor idelalisib in patients with relapsed indolent non-Hodgki lymphoma (iNHL) refractory to both rituximab and an alkylating agent. 12th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, June 19-22, 2013 Abstract No: 064bis.

ReferenceCitation: Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kdelta inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014 Mar 13;370(11):1008-18. doi: 10.1056/NEJMoa1314583. Epub 2014 Jan 22.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

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

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Ma S, Chan RJ, Gu L, Xing G, Rajakumaraswamy N, Ruzicka BB, Wagner-Johnston ND. Retrospective Analysis of the Impact of Adverse Event-Triggered Idelalisib Interruption and Dose Reduction on Clinical Outcomes in Patients With Relapsed/Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 May;21(5):e432-e448. doi: 10.1016/j.clml.2020.12.016. Epub 2020 Dec 24.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.

oa_colors: green hybrid

publisher_dissemination: Informa

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
Poland
United Kingdom
United States
France

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: John Theurer Cancer Center Hackensack University Medical Center

location_facility: Weill Cornell -New York Presbyterian Hospital

location_facility: Klinikum der Universität München-Großhadern

location_facility: University of Medicine and Dentistry of NJ

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: Fondazione Centro San Raffaele del Monte Tabor


acronym: GRID

summary:
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period.

Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery.

Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor progression is seen in a central radiology review.

Subjects receiving placebo who experience disease progression may be offered active treatment.

Subjects who experience progression during regorafenib treatment may continue open label treatment.

All subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.

ReferenceCitation: Demetri GD, Reichardt P, Kang YK, Blay JY, Rutkowski P, Gelderblom H, Hohenberger P, Leahy M, von Mehren M, Joensuu H, Badalamenti G, Blackstein M, Le Cesne A, Schoffski P, Maki RG, Bauer S, Nguyen BB, Xu J, Nishida T, Chung J, Kappeler C, Kuss I, Laurent D, Casali PG; GRID study investigators. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):295-302. doi: 10.1016/S0140-6736(12)61857-1. Epub 2012 Nov 22.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

version: submittedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central
iris.unipa.it

repositories_concat: LIRIAS (KU Leuven);PubMed Central;iris.unipa.it

ReferenceCitation: Poole CD, Connolly MP, Chang J, Currie CJ. Health utility of patients with advanced gastrointestinal stromal tumors (GIST) after failure of imatinib and sunitinib: findings from GRID, a randomized, double-blind, placebo-controlled phase III study of regorafenib versus placebo. Gastric Cancer. 2015 Jul;18(3):627-34. doi: 10.1007/s10120-014-0391-x. Epub 2014 Jun 24.

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer

ReferenceCitation: Komatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6.

publisher_dissemination: Springer-Nature

ReferenceCitation: Mross K, Frost A, Steinbild S, Hedbom S, Buchert M, Fasol U, Unger C, Kratzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.

title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care for Subjects With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) Whose Disease Has Progressed Despite Prior Treatment With at Least Imatinib and Sunitinib

location_country:
Finland
Germany
Italy
Poland
Israel
Singapore
United Kingdom
Japan
Netherlands
Austria
Belgium
United States
China
Korea, Republic of
Spain
Canada
France


title: BRF113929: An Open-Label, Two-Cohort, Multicentre Study of GSK2118436 as a Single Agent in Treatment Naïve and Previously Treated Subjects With BRAF Mutation-Positive Metastatic Melanoma to the Brain

acronym: Break MB

summary: This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have received any local brain therapy, and subjects in Cohort B will have received prior local therapy for brain metastases. Subjects will continue on treatment until disease progression, death, or unacceptable adverse event.

design_allocation: Non-Randomized

ReferenceCitation: Long GV, Trefzer U, Davies MA, Kefford RF, Ascierto PA, Chapman PB, Puzanov I, Hauschild A, Robert C, Algazi A, Mortier L, Tawbi H, Wilhelm T, Zimmer L, Switzky J, Swann S, Martin AM, Guckert M, Goodman V, Streit M, Kirkwood JM, Schadendorf D. Dabrafenib in patients with Val600Glu or Val600Lys BRAF-mutant melanoma metastatic to the brain (BREAK-MB): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Nov;13(11):1087-95. doi: 10.1016/S1470-2045(12)70431-X. Epub 2012 Oct 8.

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Ouellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Australia
United States
Canada
France


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

summary: The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

ReferenceCitation: Gottenberg JE, Dorner T, Bootsma H, Devauchelle-Pensec V, Bowman SJ, Mariette X, Bartz H, Oortgiesen M, Shock A, Koetse W, Galateanu C, Bongardt S, Wegener WA, Goldenberg DM, Meno-Tetang G, Kosutic G, Gordon C. Efficacy of Epratuzumab, an Anti-CD22 Monoclonal IgG Antibody, in Systemic Lupus Erythematosus Patients With Associated Sjogren's Syndrome: Post Hoc Analyses From the EMBODY Trials. Arthritis Rheumatol. 2018 May;70(5):763-773. doi: 10.1002/art.40425. Epub 2018 Apr 12.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories:
PubMed Central
Pure (Denmark)
pure.rug.nl

ReferenceCitation: Clowse ME, Wallace DJ, Furie RA, Petri MA, Pike MC, Leszczynski P, Neuwelt CM, Hobbs K, Keiserman M, Duca L, Kalunian KC, Galateanu C, Bongardt S, Stach C, Beaudot C, Kilgallen B, Gordon C; EMBODY Investigator Group. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double-Blind, Placebo-Controlled Trials. Arthritis Rheumatol. 2017 Feb;69(2):362-375. doi: 10.1002/art.39856.

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

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: University of California - eScholarship University of California

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

repositories_concat: LIRIAS (KU Leuven);PubMed Central;escholarship.org;ganymedesd.lib.unideb.hu;iris.unife.it;publicatio.bibl.u-szeged.hu

lead_sponsor: UCB Pharma

location_country:
Germany
Australia
Brazil
Czechia
France
Lithuania
United States
India
Romania
Belgium
Estonia
Puerto Rico
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


type: Other Identifier

title: A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study Of Etanercept On A Background Nsaid In The Treatment Of Adult Subjects With Non Radiographic Axial Spondyloarthritis With A 92 Week Open Label Extension

acronym: EMBARK

summary: This is a two part study. During period one there will be a comparison of Etanercept (ETN) against a placebo with both arms maintaining the background anti inflammatory drug prescribed by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory drug(NSAID).

ReferenceCitation: Schneeberger EE, Citera G, de Leon DP, Szumski AE, Kwok K, Cutri M, Dougados M. Simplified Ankylosing Spondylitis Disease Activity Score (SASDAS) Versus ASDAS: A Post Hoc Analysis of a Randomized Controlled Trial. J Rheumatol. 2022 Oct;49(10):1100-1108. doi: 10.3899/jrheum.211075. Epub 2022 Jul 15.

evidence: open (via free pdf)

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Maksymowych WP, Claudepierre P, de Hooge M, Lambert RG, Landewe R, Molto A, van der Heijde D, Bukowski JF, Jones H, Pedersen R, Szumski A, Vlahos B, Dougados M. Structural changes in the sacroiliac joint on MRI and relationship to ASDAS inactive disease in axial spondyloarthritis: a 2-year study comparing treatment with etanercept in EMBARK to a contemporary control cohort in DESIR. Arthritis Res Ther. 2021 Jan 29;23(1):43. doi: 10.1186/s13075-021-02428-8.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Leiden University - Leiden Repository

unpaywall_oa_status: gold

ReferenceCitation: Dougados M, van der Heijde D, Tsai WC, Saaibi D, Marshall L, Jones H, Pedersen R, Vlahos B, Tarallo M. Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study. Health Qual Life Outcomes. 2020 Jan 3;18(1):4. doi: 10.1186/s12955-019-1260-4.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Dougados M, Maksymowych WP, Landewe RBM, Molto A, Claudepierre P, de Hooge M, Lambert RG, Bonin R, Bukowski JF, Jones HE, Logeart I, Pedersen R, Szumski A, Vlahos B, van der Heijde D. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis. Ann Rheum Dis. 2018 Feb;77(2):221-227. doi: 10.1136/annrheumdis-2017-212008. Epub 2017 Sep 29.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Maksymowych WP, Wichuk S, Dougados M, Jones HE, Pedersen R, Szumski A, Marshall L, Bukowski JF, Lambert RG. Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2018 Jan;77(1):78-84. doi: 10.1136/annrheumdis-2017-211605. Epub 2017 Sep 29.

ReferenceCitation: Brown MA, Bird PA, Robinson PC, Mease PJ, Bosch FVD, Surian C, Jones H, Szumski A, Marshall L, Wiid Z, Dougados M. Evaluation of the effect of baseline MRI sacroiliitis and C reactive protein status on etanercept treatment response in non-radiographic axial spondyloarthritis: a post hoc analysis of the EMBARK study. Ann Rheum Dis. 2018 Jul;77(7):1091-1093. doi: 10.1136/annrheumdis-2017-211313. Epub 2017 Jul 3. No abstract available.

repository_institution: Queensland University of Technology - QUT ePrints

ReferenceCitation: Maksymowych WP, Wichuk S, Dougados M, Jones H, Szumski A, Bukowski JF, Marshall L, Lambert RG. MRI evidence of structural changes in the sacroiliac joints of patients with non-radiographic axial spondyloarthritis even in the absence of MRI inflammation. Arthritis Res Ther. 2017 Jun 6;19(1):126. doi: 10.1186/s13075-017-1342-9.

ReferenceCitation: Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Lenaerts J, van den Bosch F, Wei JC, Pedersen R, Bonin R, Jones H, Marshall L, Logeart I, Vlahos B, Bukowski JF, Maksymowych WP. Effects of Long-Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104-Week Results From a Randomized, Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1590-1598. doi: 10.1002/acr.23276. Epub 2017 Aug 31.

ReferenceCitation: Maksymowych WP, Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Van den Bosch F, Logeart I, Wajdula J, Jones H, Marshall L, Bonin R, Pedersen R, Vlahos B, Kotak S, Bukowski JF. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study. Ann Rheum Dis. 2016 Jul;75(7):1328-35. doi: 10.1136/annrheumdis-2015-207596. Epub 2015 Aug 12.

ReferenceCitation: Dougados M, van der Heijde D, Sieper J, Braun J, Maksymowych WP, Citera G, Miceli-Richard C, Wei JC, Pedersen R, Bonin R, Rahman MU, Logeart I, Wajdula J, Koenig AS, Vlahos B, Alvarez D, Bukowski JF. Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol. 2014 Aug;66(8):2091-102. doi: 10.1002/art.38721.

location_country:
Finland
France
Germany
Colombia
Hungary
Argentina
United Kingdom
Netherlands
Belgium
Korea, Republic of
Spain
Taiwan
Russian Federation
Czech Republic

location_facility: Russian Cardiology Research-and-Production Complex

location_facility: Studienambulanz, Medizinische Klinik 3, Universitaetsklinikum Erlangen

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University

location_facility: Charite - Campus Benjamin Franklin, Medizinische Klinik I - Rheumatologie

location_facility: Rheumatology Research Institute of Russian Academy of Medical Sciences

location_facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

location_facility: Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie

location_facility: Leiden University Medical Center, Reumatologie

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet/Klinikai Immunologiai es Reumatologiai Osztaly

location_facility: MEDIGREIF Verwaltungs- und Betriebsgesellschaft Fachkrankenhaus Vogelsang-Gommern mbH

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: Academic Medical Centre (AMC) / Division of Clinical Immunology and Rheumatology

location_facility: Limited Liability Company NMC Tomography

location_facility: Norfolk and Norwich University Hospital NHS Trust

location_facility: Saint-Petersburg State Budgetary Healthcare Institution


title: A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye

summary: The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).

lead_sponsor: Lux Biosciences, Inc.

location_country:
France
Germany
Italy
United Kingdom
Brazil
Austria
United States
Canada
Czech Republic


title: A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.

summary: Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).

ReferenceCitation: Baulac M, Rosenow F, Toledo M, Terada K, Li T, De Backer M, Werhahn KJ, Brock M. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2017 Jan;16(1):43-54. doi: 10.1016/S1474-4422(16)30292-7. Epub 2016 Nov 24. Erratum In: Lancet Neurol. 2017 Feb;16(2):102.

ReferenceCitation: Mintzer S, Dimova S, Zhang Y, Steiniger-Brach B, De Backer M, Chellun D, Roebling R. Effects of lacosamide and carbamazepine on lipids in a randomized trial. Epilepsia. 2020 Dec;61(12):2696-2704. doi: 10.1111/epi.16745. Epub 2020 Nov 17.

ReferenceCitation: Lindauer A, Laveille C, Stockis A. Time-to-Seizure Modeling of Lacosamide Used in Monotherapy in Patients with Newly Diagnosed Epilepsy. Clin Pharmacokinet. 2017 Nov;56(11):1403-1413. doi: 10.1007/s40262-017-0530-8.

lead_sponsor: UCB BIOSCIENCES GmbH

sponsor_collaborators:
UCB BIOSCIENCES GmbH
Eden Sarl

location_country:
Finland
Germany
Poland
Australia
Japan
Thailand
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Sweden


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas

acronym: GAMMA

summary:
AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival.

Gemcitabine is administered on days 1, 8 and 15 of a 28 day cycle, AMG 479 or placebo is administered on days 1 and 15 of the 28 day cycle, both are administered intravenously.

The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.

status: Terminated

ReferenceCitation: Fuchs CS, Azevedo S, Okusaka T, Van Laethem JL, Lipton LR, Riess H, Szczylik C, Moore MJ, Peeters M, Bodoky G, Ikeda M, Melichar B, Nemecek R, Ohkawa S, Swieboda-Sadlej A, Tjulandin SA, Van Cutsem E, Loberg R, Haddad V, Gansert JL, Bach BA, Carrato A. A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. Ann Oncol. 2015 May;26(5):921-927. doi: 10.1093/annonc/mdv027. Epub 2015 Jan 21.

lead_sponsor: NantCell, Inc.

sponsor_collaborators:
NantCell, Inc.
Takeda

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Canada
Serbia
France
Czech Republic
Lithuania
Slovenia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Sweden

status_simplified: Unknown


title: A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients

summary: The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

ReferenceCitation: Pawlotsky JM, Flisiak R, Sarin SK, Rasenack J, Piratvisuth T, Chuang WL, Peng CY, Foster GR, Shah S, Wedemeyer H, Hezode C, Zhang W, Wong KA, Li B, Avila C, Naoumov NV; VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. 2015 Oct;62(4):1013-23. doi: 10.1002/hep.27960. Epub 2015 Aug 10.

lead_sponsor: Debiopharm International SA

location_country:
Germany
Italy
Poland
India
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Thailand
Taiwan
Canada
Puerto Rico
France

location_facility:
The North Texas Research Institute
Alamo Medical Research
Liver Associates of Texas
Novartis Inestigative Site
Columbia University Medical Center
Novartis Korea Ltd.
Sharp Rees-Stealy Medical Group, Inc.
The Office of Dr. Claudia Martorell
Novartis Investigative Center
Fundacion de Investigacion de Diego
Island View Gastroenterology Associates
Cotton O'Neil Clinical Research
Novartis Inestigative Center
Dartmouth-Hitchcock Medical Center
Research and Education Inc.
Weill Cornell Medical Center
Novartis Investigative Site
Scripps Clinic
Mount Sinai Medical Center
Hawai Medical Center East LLC
Liver Specialist of Texas
Saint Louis University


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) in Subjects With Active Psoriatic Arthritis and a Qualifying Psoriasis Lesion

acronym: PALACE 3

summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

ReferenceCitation: Edwards CJ, Blanco FJ, Crowley J, Birbara CA, Jaworski J, Aelion J, Stevens RM, Vessey A, Zhan X, Bird P. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement: a phase III, randomised, controlled trial (PALACE 3). Ann Rheum Dis. 2016 Jun;75(6):1065-73. doi: 10.1136/annrheumdis-2015-207963. Epub 2016 Jan 20.

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

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

repository_normalized: dnet

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

ReferenceCitation: Mease PJ, Gladman DD, Kavanaugh A, McGonagle D, Nash P, Guerette B, Nakasato P, Brunori M, Teng L, McInnes IB. Articular and Extra-Articular Benefits in ACR20 Non-responders at Week 104 Treated With Apremilast: Pooled Analysis of Three Randomized Controlled Trials. Rheumatol Ther. 2021 Dec;8(4):1677-1691. doi: 10.1007/s40744-021-00369-x. Epub 2021 Sep 18.

ReferenceCitation: Mease PJ, Gladman DD, Ogdie A, Coates LC, Behrens F, Kavanaugh A, McInnes I, Queiro R, Guerette B, Brunori M, Teng L, Smolen JS. Treatment-to-Target With Apremilast in Psoriatic Arthritis: The Probability of Achieving Targets and Comprehensive Control of Disease Manifestations. Arthritis Care Res (Hoboken). 2020 Jun;72(6):814-821. doi: 10.1002/acr.24134. Epub 2020 May 8.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: PubMed Central;eprints.gla.ac.uk

ReferenceCitation: Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.

ReferenceCitation: Gladman DD, Kavanaugh A, Gomez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Finland
Germany
Italy
Lithuania
Poland
Slovakia
United Kingdom
Romania
Australia
Switzerland
United States
Korea, Republic of
Spain
Canada
Russian Federation
France

location_facility: Menzies Centre for Population Health Research

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Centre Hospitalier Sud Francilien - Site Gilles de Corbeil

location_facility: Baia Mare, Emergency County Hospital "Dr. Constantin Opris"

location_facility: Hospital of Lithuanian University Health and Sciences

location_facility: Sf Apostol Andrei Emergency Clinical County Hospital

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Hospital Universitario Central de Asturias

location_facility: REUMATIKA-Centrum Reumatologii Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Catalina Pointe Clinical Research Incorporated

location_facility: Klinikum der Friedrich-Schiller-Universität Jena

location_facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko

location_facility: Research Institute of Clinical and Experimental Lymphology

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk


title: Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients With Chronic Hepatitis B Virus Infection Who Are HBeAg-positive

acronym: LIRA-B

summary:
At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis B virus infection (CHB)

Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in combination with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach

ReferenceCitation: Phillips S, Mistry S, Riva A, Cooksley H, Hadzhiolova-Lebeau T, Plavova S, Katzarov K, Simonova M, Zeuzem S, Woffendin C, Chen PJ, Peng CY, Chang TT, Lueth S, De Knegt R, Choi MS, Wedemeyer H, Dao M, Kim CW, Chu HC, Wind-Rotolo M, Williams R, Cooney E, Chokshi S. Peg-Interferon Lambda Treatment Induces Robust Innate and Adaptive Immunity in Chronic Hepatitis B Patients. Front Immunol. 2017 May 29;8:621. doi: 10.3389/fimmu.2017.00621. eCollection 2017.

repository_institution: PubMed Central - Europe PMC

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher_dissemination: Frontiers

ReferenceCitation: Chan HLY, Ahn SH, Chang TT, Peng CY, Wong D, Coffin CS, Lim SG, Chen PJ, Janssen HLA, Marcellin P, Serfaty L, Zeuzem S, Cohen D, Critelli L, Xu D, Wind-Rotolo M, Cooney E; LIRA-B Study Team. Peginterferon lambda for the treatment of HBeAg-positive chronic hepatitis B: A randomized phase 2b study (LIRA-B). J Hepatol. 2016 May;64(5):1011-1019. doi: 10.1016/j.jhep.2015.12.018. Epub 2015 Dec 29.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Hong Kong
Singapore
Australia
Netherlands
United States
Korea, Republic of
Taiwan
Canada
France

location_facility: Toronto Western Hospital University Health Network

location_facility: Atlanta Gastroenterology Associates, Llc

location_facility: University Of California, Davis Medical Center

location_facility: Heritage Medical Research Clinic, University Of Calgary


acronym: SHINE

summary: The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.

ReferenceCitation: Kulich K, Keininger DL, Tiplady B, Banerji D. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis. 2015 Jan 7;10:79-94. doi: 10.2147/COPD.S73092. eCollection 2015.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

location_facility:
Novartis INvestigative Site
Novartis Investigative Site
Novartis Inverstigative Site
Novartis Investigative site

title: A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

location_country:
Germany
Poland
Australia
Japan
Turkey
Canada
France
Slovakia
Hungary
Switzerland
United States
Philippines
Guatemala
United Kingdom
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


lead_sponsor: Novartis

summary: This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.

location_facility:
Novartis Investigational Site
Novartis Investigative Site

title: A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS)

location_country:
Finland
Poland
Guatemala
United Kingdom
Switzerland
Belgium
Spain
Canada
France


acronym: aHUS

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.

ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD012862. doi: 10.1002/14651858.CD012862.pub2.

ReferenceCitation: Tschumi S, Gugger M, Bucher BS, Riedl M, Simonetti GD. Eculizumab in atypical hemolytic uremic syndrome: long-term clinical course and histological findings. Pediatr Nephrol. 2011 Nov;26(11):2085-8. doi: 10.1007/s00467-011-1989-4. Epub 2011 Aug 30.

title: An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome

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


title: An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination With Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or Nab-Paclitaxel in Subjects With Advanced Solid Tumors

summary: The purpose of this study is to determine what dose of GSK1120212 can be given safely in combination with at least one other drug that is already approved to treat cancer. This study will test the safety of up to 6 different GSK1120212 study treatment combinations (GSK1120212 plus either docetaxel, erlotinib, pemetrexed, pemetrexed + carboplatin, pemetrexed + cisplatin, or nab-paclitaxel). The doses identified in this study may be used in future trials to test whether the combination treatment is a safe and effective therapy for subjects with metastatic lung and/or pancreatic cancers.

ReferenceCitation: Gandara DR, Leighl N, Delord JP, Barlesi F, Bennouna J, Zalcman G, Infante JR, Reckamp KL, Kelly K, Shepherd FA, Mazieres J, Janku F, Gardner OS, Mookerjee B, Wu Y, Cox DS, Schramek D, Peddareddigari V, Liu Y, D'Amelio AM Jr, Blumenschein G Jr. A Phase 1/1b Study Evaluating Trametinib Plus Docetaxel or Pemetrexed in Patients With Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2017 Mar;12(3):556-566. doi: 10.1016/j.jtho.2016.11.2218. Epub 2016 Nov 19.

license: publisher-specific-oa

license_normalized: publisher-specific

repository_normalized: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

location_country:
United States
Canada
Korea, Republic of
France


title: Ph3,DB/DD,Multi-Ctr,Pros,Rand Study-Efficacy and Safety of LCP-Tacro™ Tablets, QD, Compared to Prograf® Capsules,BID, in Combination With Mycophenolate Mofetil for Acute Allograft Rejection in De Novo Kidney Transplant

summary: This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treated for a 12 month study period followed by a 12 month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically similar to Prograf Capsules in the prevention of acute rejection.

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Veloxis Pharmaceuticals

location_country:
Germany
Italy
Poland
New Zealand
Argentina
Singapore
Australia
Brazil
Sweden
Mexico
United States
Korea, Republic of
Spain
Serbia
France

location_facility:
Clinical Site 1055
Clinical Site 1061
Clinical Site 1026
Clinical Site 33131
Clinical Site 1032
Clinical Site 1039
Clinical Site 1045
Clinical Site 39144
Clinical Site 1011
Clinical Site 381142
Clinical Site 34151
Clinical Site 1013
Clinical Site 1056
Clinical Site 1053
Clinical Site 55171
Clinical Site 1031
Clinical Site 48149
Clinical Site 52182
Clinical Site 1047
Clinical Site 1008
Clinical Site 55178
Clinical Site 55173
Clinical Site 1046
Clinical Site 1049
Clinical Site 1048
Clinical Site 65127
Clinical Site 33132
Clinical Site 1003
Clinical Site 1038
Clinical Site 54163
Clinical Site 1051
Clinical Site 52184
Clinical Site 1042
Clinical Site 61101
Clinical Site 1009
Clinical Site 1040
Clinical Site 1006
Clinical Site 1044
Clinical Site 1021
Clinical Site 61102
Clinical Site 34155
Clinical Site 1023
Clinical Site 1035
Clinical Site 381141
Clinical Site 1014
Clinical Site 33136
Clinical Site 65126
Clinical Site 1018
Clinical Site 55179
Clinical Site 34157
Clinical Site 61105
Clinical Site 55172
Clinical Site 1010
Clinical Site 61100
Clinical Site 1054
Clinical Site 48148
Clinical Site 52181
Clinical Site 49137
Clinical Site 61104
Clinical Site 33134
Clinical Site 1050
Clinical Site 1020
Clinical Site 64112
Clinical Site 381140
Clinical Site 48151
Clinical Site 1037
Clinical Site 54164
Clinical Site 61106
Clinical Site 64121
Clinical Site 92113
Clinical Site 46161
Clinical Site 1058
Clinical Site 1060
Clinical Site 1029
Clinical Site 1036
Clinical Site 49139
Clinical Site 1022
Clinical Site 1033
Clinical Site 1052
Clinical Site 55175
Clinical Site 1019
Clinical Site 1005
Clinical Site 1012
Clinical Site 1025
Clinical Site 52183
Clinical Site 1027


acronym: LEADER®

lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.

ReferenceCitation: Verma S, Bain SC, Monk Fries T, Mazer CD, Nauck MA, Pratley RE, Rasmussen S, Saevereid HA, Zinman B, Buse JB. Duration of diabetes and cardiorenal efficacy of liraglutide and semaglutide: A post hoc analysis of the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2019 Jul;21(7):1745-1751. doi: 10.1111/dom.13698. Epub 2019 Apr 2.

ReferenceCitation: Hinton W, Feher M, Munro N, Walker M, de Lusignan S. Real-world prevalence of the inclusion criteria for the LEADER trial: Data from a national general practice network. Diabetes Obes Metab. 2019 Jul;21(7):1661-1667. doi: 10.1111/dom.13710. Epub 2019 Apr 11.

ReferenceCitation: Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

repository_institution: Imperial College London - Spiral

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: Koç University - Digital Collections portal

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_institution: Koç University - Digital Collections portal

repositories_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Petrie JR, Marso SP, Bain SC, Franek E, Jacob S, Masmiquel L, Leiter LA, Haluzik M, Satman I, Omar M, Shestakova M, Van Gaal L, Mann JF, Baeres FM, Zinman B, Poulter NR; LEADER investigators. LEADER-4: blood pressure control in patients with type 2 diabetes and high cardiovascular risk: baseline data from the LEADER randomized trial. J Hypertens. 2016 Jun;34(6):1140-50. doi: 10.1097/HJH.0000000000000890.

repository_institution: Swansea University - Cronfa

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Masmiquel L, Leiter LA, Vidal J, Bain S, Petrie J, Franek E, Raz I, Comlekci A, Jacob S, van Gaal L, Baeres FM, Marso SP, Eriksson M; LEADER investigators. LEADER 5: prevalence and cardiometabolic impact of obesity in cardiovascular high-risk patients with type 2 diabetes mellitus: baseline global data from the LEADER trial. Cardiovasc Diabetol. 2016 Feb 10;15:29. doi: 10.1186/s12933-016-0341-5.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

ReferenceCitation: Satman I, R Rea R, Eriksson M, Mosenzon O, Pratley R, M Baeres F, D Orsted D, F Mann J; LEADER Trial Investigators. LEADER-6: Baseline renal function and associated factors in a high cardiovascular risk type 2 diabetes population. J Diabetes Complications. 2016 Nov-Dec;30(8):1631-1639. doi: 10.1016/j.jdiacomp.2016.06.001. Epub 2016 Jun 3.

ReferenceCitation: Rutten GE, Tack CJ, Pieber TR, Comlekci A, Orsted DD, Baeres FM, Marso SP, Buse JB; LEADER Investigators. LEADER 7: cardiovascular risk profiles of US and European participants in the LEADER diabetes trial differ. Diabetol Metab Syndr. 2016 Jun 2;8:37. doi: 10.1186/s13098-016-0153-5. eCollection 2016.

ReferenceCitation: Marso SP, Poulter NR, Nissen SE, Nauck MA, Zinman B, Daniels GH, Pocock S, Steinberg WM, Bergenstal RM, Mann JF, Ravn LS, Frandsen KB, Moses AC, Buse JB. Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial. Am Heart J. 2013 Nov;166(5):823-30.e5. doi: 10.1016/j.ahj.2013.07.012. Epub 2013 Oct 2.

ReferenceCitation: Steinberg WM, Nauck MA, Zinman B, Daniels GH, Bergenstal RM, Mann JF, Steen Ravn L, Moses AC, Stockner M, Baeres FM, Marso SP, Buse JB; LEADER Trial investigators. LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial. Pancreas. 2014 Nov;43(8):1223-31. doi: 10.1097/MPA.0000000000000229.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Daniels GH, Hegedus L, Marso SP, Nauck MA, Zinman B, Bergenstal RM, Mann JF, Derving Karsbol J, Moses AC, Buse JB, Tuttle RM; LEADER Trial Investigators. LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations. Diabetes Obes Metab. 2015 May;17(5):477-86. doi: 10.1111/dom.12444. Epub 2015 Feb 23.

ReferenceCitation: Steinberg WM, Buse JB, Ghorbani MLM, Orsted DD, Nauck MA; LEADER Steering Committee; LEADER Trial Investigators. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial. Diabetes Care. 2017 Jul;40(7):966-972. doi: 10.2337/dc16-2747. Epub 2017 May 5.

ReferenceCitation: Mann JFE, Orsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornoe K, Zinman B, Buse JB; LEADER Steering Committee and Investigators. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Aug 31;377(9):839-848. doi: 10.1056/NEJMoa1616011.

repository_institution: Universidade Federal do Rio Grande do Sul - Lume

repository_institution: James Cook University - ResearchOnline at James Cook University

repositories_institution: Universidade Federal do Rio Grande do Sul - Lume

ReferenceCitation: Hegedus L, Sherman SI, Tuttle RM, von Scholten BJ, Rasmussen S, Karsbol JD, Daniels GH; LEADER Publication Committee on behalf of the LEADER Trial Investigators. No Evidence of Increase in Calcitonin Concentrations or Development of C-Cell Malignancy in Response to Liraglutide for Up to 5 Years in the LEADER Trial. Diabetes Care. 2018 Mar;41(3):620-622. doi: 10.2337/dc17-1956. Epub 2017 Dec 26.

ReferenceCitation: Marso SP, Nauck MA, Monk Fries T, Rasmussen S, Treppendahl MB, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Myocardial Infarction Subtypes in Patients With Type 2 Diabetes Mellitus and the Effect of Liraglutide Therapy (from the LEADER Trial). Am J Cardiol. 2018 Jun 15;121(12):1467-1470. doi: 10.1016/j.amjcard.2018.02.030. Epub 2018 Mar 15.

ReferenceCitation: Verma S, Bhatt DL, Bain SC, Buse JB, Mann JFE, Marso SP, Nauck MA, Poulter NR, Pratley RE, Zinman B, Michelsen MM, Monk Fries T, Rasmussen S, Leiter LA; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Polyvascular Disease: Results of the LEADER Trial. Circulation. 2018 May 15;137(20):2179-2183. doi: 10.1161/CIRCULATIONAHA.118.033898. No abstract available.

repositories_institution:
Imperial College London - Spiral
Swansea University - Cronfa

ReferenceCitation: Nauck MA, Jensen TJ, Rosenkilde C, Calanna S, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Neoplasms Reported With Liraglutide or Placebo in People With Type 2 Diabetes: Results From the LEADER Randomized Trial. Diabetes Care. 2018 Aug;41(8):1663-1671. doi: 10.2337/dc17-1825. Epub 2018 Jun 13.

ReferenceCitation: Zinman B, Marso SP, Christiansen E, Calanna S, Rasmussen S, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Hypoglycemia, Cardiovascular Outcomes, and Death: The LEADER Experience. Diabetes Care. 2018 Aug;41(8):1783-1791. doi: 10.2337/dc17-2677. Epub 2018 Jun 14.

ReferenceCitation: Nauck MA, Tornoe K, Rasmussen S, Treppendahl MB, Marso SP; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Cardiovascular outcomes in patients who experienced a myocardial infarction while treated with liraglutide versus placebo in the LEADER trial. Diab Vasc Dis Res. 2018 Sep;15(5):465-468. doi: 10.1177/1479164118783935. Epub 2018 Jun 27.

ReferenceCitation: Dhatariya K, Bain SC, Buse JB, Simpson R, Tarnow L, Kaltoft MS, Stellfeld M, Tornoe K, Pratley RE; LEADER Publication Committee on behalf of the LEADER Trial Investigators. The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial. Diabetes Care. 2018 Oct;41(10):2229-2235. doi: 10.2337/dc18-1094. Epub 2018 Aug 2.

ReferenceCitation: Verma S, Leiter LA, Mazer CD, Bain SC, Buse J, Marso S, Nauck M, Zinman B, Bosch-Traberg H, Rasmussen S, Michelsen MM, Bhatt DL. Liraglutide Reduces Cardiovascular Events and Mortality in Type 2 Diabetes Mellitus Independently of Baseline Low-Density Lipoprotein Cholesterol Levels and Statin Use. Circulation. 2018 Oct 9;138(15):1605-1607. doi: 10.1161/CIRCULATIONAHA.118.036862. No abstract available.

ReferenceCitation: Mann JFE, Fonseca V, Mosenzon O, Raz I, Goldman B, Idorn T, von Scholten BJ, Poulter NR. Effects of Liraglutide Versus Placebo on Cardiovascular Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease. Circulation. 2018 Dec 18;138(25):2908-2918. doi: 10.1161/CIRCULATIONAHA.118.036418.

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Verma S, Poulter NR, Bhatt DL, Bain SC, Buse JB, Leiter LA, Nauck MA, Pratley RE, Zinman B, Orsted DD, Monk Fries T, Rasmussen S, Marso SP. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus With or Without History of Myocardial Infarction or Stroke. Circulation. 2018 Dec 18;138(25):2884-2894. doi: 10.1161/CIRCULATIONAHA.118.034516.

ReferenceCitation: Nauck MA, Buse JB, Mann JFE, Pocock S, Bosch-Traberg H, Frimer-Larsen H, Ye Q, Gray A; LEADER Publication Committee for the LEADER Trial Investigators. Health-related quality of life in people with type 2 diabetes participating in the LEADER trial. Diabetes Obes Metab. 2019 Mar;21(3):525-532. doi: 10.1111/dom.13547. Epub 2018 Oct 25.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Zinman B, Nauck MA, Bosch-Traberg H, Frimer-Larsen H, Orsted DD, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Liraglutide and Glycaemic Outcomes in the LEADER Trial. Diabetes Ther. 2018 Dec;9(6):2383-2392. doi: 10.1007/s13300-018-0524-z. Epub 2018 Nov 3.

ReferenceCitation: Gilbert MP, Bain SC, Franek E, Jodar-Gimeno E, Nauck MA, Pratley R, Rea RR, Kerr Saraiva JF, Rasmussen S, Tornoe K, von Scholten BJ, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effect of Liraglutide on Cardiovascular Outcomes in Elderly Patients: A Post Hoc Analysis of a Randomized Controlled Trial. Ann Intern Med. 2019 Mar 19;170(6):423-426. doi: 10.7326/M18-1569. Epub 2018 Dec 4. No abstract available.

ReferenceCitation: Verma S, Al-Omran M, Leiter LA, Mazer CD, Rasmussen S, Saevereid HA, Sejersten Ripa M, Bonaca MP. Cardiovascular efficacy of liraglutide and semaglutide in individuals with diabetes and peripheral artery disease. Diabetes Obes Metab. 2022 Jul;24(7):1288-1299. doi: 10.1111/dom.14700. Epub 2022 Apr 11.

ReferenceCitation: Heller SR, Geybels MS, Iqbal A, Liu L, Wagner L, Chow E. A higher non-severe hypoglycaemia rate is associated with an increased risk of subsequent severe hypoglycaemia and major adverse cardiovascular events in individuals with type 2 diabetes in the LEADER study. Diabetologia. 2022 Jan;65(1):55-64. doi: 10.1007/s00125-021-05556-7. Epub 2021 Oct 26.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Persson F, Bain SC, Mosenzon O, Heerspink HJL, Mann JFE, Pratley R, Raz I, Idorn T, Rasmussen S, von Scholten BJ, Rossing P; LEADER Trial Investigators. Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial. Diabetes Care. 2021 Apr;44(4):1020-1026. doi: 10.2337/dc20-1622. Epub 2021 Jan 27.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Verma S, McGuire DK, Bain SC, Bhatt DL, Leiter LA, Mazer CD, Monk Fries T, Pratley RE, Rasmussen S, Vrazic H, Zinman B, Buse JB. Effects of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across body mass index categories in type 2 diabetes: Results of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Dec;22(12):2487-2492. doi: 10.1111/dom.14160. Epub 2020 Sep 4.

ReferenceCitation: Crowley MJ, McGuire DK, Alexopoulos AS, Jensen TJ, Rasmussen S, Saevereid HA, Verma S, Buse JB. Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial. Diabetes Care. 2020 Sep;43(9):e108-e110. doi: 10.2337/dc20-0437. Epub 2020 Jul 9. No abstract available.

ReferenceCitation: Verma S, Bain SC, Honore JB, F E Mann J, A Nauck M, E Pratley R, Rasmussen S, Sejersten Ripa M, Zinman B, Buse JB. Impact of microvascular disease on cardiovascular outcomes in type 2 diabetes: Results from the LEADER and SUSTAIN 6 clinical trials. Diabetes Obes Metab. 2020 Nov;22(11):2193-2198. doi: 10.1111/dom.14140. Epub 2020 Aug 12.

ReferenceCitation: Leiter LA, Bain SC, Bhatt DL, Buse JB, Mazer CD, Pratley RE, Rasmussen S, Ripa MS, Vrazic H, Verma S. The effect of glucagon-like peptide-1 receptor agonists liraglutide and semaglutide on cardiovascular and renal outcomes across baseline blood pressure categories: Analysis of the LEADER and SUSTAIN 6 trials. Diabetes Obes Metab. 2020 Sep;22(9):1690-1695. doi: 10.1111/dom.14079. Epub 2020 Jun 3.

ReferenceCitation: Buse JB, Bain SC, Mann JFE, Nauck MA, Nissen SE, Pocock S, Poulter NR, Pratley RE, Linder M, Monk Fries T, Orsted DD, Zinman B; LEADER Trial Investigators. Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial. Diabetes Care. 2020 Jul;43(7):1546-1552. doi: 10.2337/dc19-2251. Epub 2020 May 4.

ReferenceCitation: Marso SP, Baeres FMM, Bain SC, Goldman B, Husain M, Nauck MA, Poulter NR, Pratley RE, Thomsen AB, Buse JB; LEADER Trial Investigators. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure. J Am Coll Cardiol. 2020 Mar 17;75(10):1128-1141. doi: 10.1016/j.jacc.2019.12.063.

ReferenceCitation: Mann JFE, Fonseca VA, Poulter NR, Raz I, Idorn T, Rasmussen S, von Scholten BJ, Mosenzon O; LEADER Trial Investigators. Safety of Liraglutide in Type 2 Diabetes and Chronic Kidney Disease. Clin J Am Soc Nephrol. 2020 Apr 7;15(4):465-473. doi: 10.2215/CJN.11881019. Epub 2020 Mar 4.

ReferenceCitation: Nauck MA, Kreiner E, Rasmussen S, Saevereid HA, Buse JB; LEADER Trial Investigators. Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920. Diabetes Care. 2020 Feb;43(2):e30-e31. doi: 10.2337/dci19-0067. No abstract available.

ReferenceCitation: Verma S, Bain SC, Buse JB, Idorn T, Rasmussen S, Orsted DD, Nauck MA. Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2019 Dec 1;4(12):1214-1220. doi: 10.1001/jamacardio.2019.3080.

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: Nauck MA, Muus Ghorbani ML, Kreiner E, Saevereid HA, Buse JB; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care. 2019 Oct;42(10):1912-1920. doi: 10.2337/dc19-0415. Epub 2019 Aug 9.

ReferenceCitation: Tack CJ, Jacob S, Desouza C, Bain SC, Buse JB, Nauck MA, Petrie JR, Poulter NR, Pratley RE, Stegmann HVBK, Bosch-Traberg H, Startseva E, Zinman B; LEADER Publication Committee on behalf of the LEADER Trial Investigators. Long-term efficacy and safety of combined insulin and glucagon-like peptide-1 therapy: Evidence from the LEADER trial. Diabetes Obes Metab. 2019 Nov;21(11):2450-2458. doi: 10.1111/dom.13826. Epub 2019 Jul 7.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.

title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

location_country:
Finland
Germany
Ireland
Poland
Australia
Brazil
Turkey
Czechia
Canada
Serbia
France
Denmark
United States
India
Romania
Belgium
China
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
United Arab Emirates
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel


title: A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B

acronym: EPIC B

summary: The purpose of this study is to collect epidemiological data in children and adolescents with chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with associated ALT levels , active HBeAg negative disease and decompensated CHB in the pediatric population. Family history and history of HBV transmission is essential to assess the course of the disease and can be used to determine the best mode of treatment This information will be used to assist with the feasibility and design of studies for the Novartis clinical pediatric development program, as the current epidemiology of ediatric CHB is not accurately known in Western countries or the rest of the world making pediatric studies difficult to plan and conduct. This study forms part of the Novartis Pediatric Investigational Plan, a post marketing approval commitment to the EMEA Pediatric Committee.

study_type: Observational

time_perspective: Retrospective

location_country:
Italy
Poland
Russian Federation
India
United Kingdom
Argentina
Romania
Singapore
Brazil
United States
China
Spain
Thailand
Greece
Taiwan
Peru
Philippines
France

location_facility: Peripheral University General Hospital of Alexandroupoli

location_facility: Second Hospital of Xian Jiaotong University

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Hospital Universitario San Cecilio, Granada

location_facility: University General Hospital of Heraklion, Heraklion

location_facility: Istituto G. Gaslini Ospedale Pediatrico IRCCS

location_facility: Henan Academy of Medical Pharmaceutical Sciences, Zhengzhou

location_facility: 1st Affliated Hospital of 3rd Military Med. Univ. of PLA

location_facility: Shands Hospital at University of Florida

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux

location_facility: The Third Xiangya Hospital of Central South University, Changsha

location_facility: Saint- Petersburg State Mtchnikov's Medical Academy

location_facility: "Agia Sofia" Childrens Hospital of Athens

location_facility: The First Affiliated Hospital of Soochow University

location_facility: The First Affiliated Hospital of Lanzhou University

location_facility: Research Institute for Infectious Childhood Diseases

location_facility: The First Affiliated Hospital of Chongqing Med. University

location_facility: Saint Vincent Healthcare Pediatric Specialty Clinics

location_facility: Institute of Hematol., Union Hospital, Tongji Med. College

location_facility: Maulana Azad Medical College & LNJP Hospital

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: St. John's Medical College Hospital, Banglaore

location_facility: The First Affiliated Hospital of Medical College, Kunming

location_facility: Hospital Oswaldo Cruz - Universidade de Pernambuco

location_facility: Hospital of Chengdu Military Area Command, Kunming

location_facility: Núcleo de Estudos e Pesquisas em Hepatologia da Amazônia

location_facility: V. Babes Pneumology and Infectious Diseases Clin. Hosp

location_facility: Hospital de Clínicas de Porto Alegre, Porto

location_facility: Azienda Osp.-Univ. Bologna - Policlinico S.Orsola-Malpighi

location_facility: "Matei Bals" Institute of Infectious Diseases

location_facility: Hospital de Niños Dr. Ricardo Gutierrez, Capital Federal

location_facility: First Hospital University of Jilin, Changchun

location_facility: Research Institute for Tropical Medicine

location_facility: Central Research Institute for Epidemiology of Rospotrebnadz

location_facility: Childrens' General Hospital of Athens 'P&A Kyriakou'

location_facility: Hebei Medical University The Third Hospital, Shijiazhuang

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: National Kidney and Transplant Institute

location_facility: Azienda Ospedaliero Universitaria Pisana


title: Study of GSK2302032A Antigen-Specific Cancer Immunotherapeutic in Patients With Resectable Non-Small Cell Lung Cancer

summary: The purpose of this clinical study is to assess the safety and immunogenicity of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery.

ReferenceCitation: Pujol JL, De Pas T, Rittmeyer A, Vallieres E, Kubisa B, Levchenko E, Wiesemann S, Masters GA, Shen R, Tjulandin SA, Hofmann HS, Vanhoutte N, Salaun B, Debois M, Jarnjak S, De Sousa Alves PM, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of the PRAME Cancer Immunotherapeutic in Patients with Resected Non-Small Cell Lung Cancer: A Phase I Dose Escalation Study. J Thorac Oncol. 2016 Dec;11(12):2208-2217. doi: 10.1016/j.jtho.2016.08.120. Epub 2016 Aug 17.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Germany
Italy
Poland
United States
Russian Federation
France

intervention_type: Biological


summary: The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.

ReferenceCitation: Willmann S, Thelen K, Kubitza D, Lensing AWA, Frede M, Coboeken K, Stampfuss J, Burghaus R, Muck W, Lippert J. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:32. doi: 10.1186/s12959-018-0185-1. eCollection 2018.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Kubitza D, Willmann S, Becka M, Thelen K, Young G, Brandao LR, Monagle P, Male C, Chan A, Kennet G, Martinelli I, Saracco P, Lensing AWA. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:31. doi: 10.1186/s12959-018-0186-0. eCollection 2018.

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;localhost

ReferenceCitation: Willmann S, Becker C, Burghaus R, Coboeken K, Edginton A, Lippert J, Siegmund HU, Thelen K, Muck W. Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban. Clin Pharmacokinet. 2014 Jan;53(1):89-102. doi: 10.1007/s40262-013-0090-5.

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

title: Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

location_country:
Germany
Ireland
Italy
Israel
Australia
Switzerland
Austria
United States
Canada
France


summary: The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.

ReferenceCitation: Ahmad HA, Baker JF, Conaghan PG, Emery P, Huizinga TWJ, Elbez Y, Banerjee S, Ostergaard M. Prediction of flare following remission and treatment withdrawal in early rheumatoid arthritis: post hoc analysis of a phase IIIb trial with abatacept. Arthritis Res Ther. 2022 Feb 16;24(1):47. doi: 10.1186/s13075-022-02735-8.

repository_institution: Leiden University - Leiden Repository

ReferenceCitation: Keystone EC, Ahmad HA, Yazici Y, Bergman MJ. Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials. Rheumatology (Oxford). 2020 Aug 1;59(8):2090-2098. doi: 10.1093/rheumatology/kez455.

publisher_dissemination: Oxford University Press

ReferenceCitation: Ahmad HA, Baker JF, Ostergaard M, Ye J, Emery P, Conaghan PG. Determining MRI Inflammation Targets When Considering a Rheumatoid Arthritis Treat-to-Target Strategy: Results of a Randomized, Placebo-Controlled Trial. Adv Ther. 2019 Sep;36(9):2384-2393. doi: 10.1007/s12325-019-01020-6. Epub 2019 Jul 5.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repositories:
PubMed Central
Pure (Denmark)
eprints.whiterose.ac.uk

repositories_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Emery P, Burmester GR, Bykerk VP, Combe BG, Furst DE, Maldonado MA, Huizinga TW. Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study. RMD Open. 2019 Feb 8;5(1):e000840. doi: 10.1136/rmdopen-2018-000840. eCollection 2019.

ReferenceCitation: Bykerk VP, Burmester GR, Combe BG, Furst DE, Huizinga TWJ, Ahmad HA, Emery P. On-drug and drug-free remission by baseline symptom duration: abatacept with methotrexate in patients with early rheumatoid arthritis. Rheumatol Int. 2018 Dec;38(12):2225-2231. doi: 10.1007/s00296-018-4173-3. Epub 2018 Oct 20. Erratum In: Rheumatol Int. 2019 Feb 5;:

ReferenceCitation: Peterfy C, Burmester GR, Bykerk VP, Combe BG, DiCarlo JC, Furst DE, Huizinga TW, Wong DA, Conaghan PG, Emery P. Sustained improvements in MRI outcomes with abatacept following the withdrawal of all treatments in patients with early, progressive rheumatoid arthritis. Ann Rheum Dis. 2016 Aug;75(8):1501-5. doi: 10.1136/annrheumdis-2015-208258. Epub 2016 Feb 10.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Emery P, Burmester GR, Bykerk VP, Combe BG, Furst DE, Barre E, Karyekar CS, Wong DA, Huizinga TW. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis. 2015 Jan;74(1):19-26. doi: 10.1136/annrheumdis-2014-206106. Epub 2014 Nov 3.

location_facility: Johns Hopkins University Division Of Rheumatology

location_facility: Rheumatology Associates Of North Alabama, P.C.

title: A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA

location_country:
Finland
Germany
Italy
Poland
Denmark
Australia
Sweden
Mexico
Belgium
United States
Korea, Republic of
South Africa
Canada
Russian Federation
France


title: EVOLVE: A Prospective Randomized Multicenter Single-blind Non-inferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System (Evolution Stent System) for the Treatment of a De Novo Atherosclerotic Lesion

acronym: Evolve

summary: The purpose of the EVOLVE Trial is to assess the safety and performance of the everolimus-eluting Evolution stent for the treatment of a de novo atherosclerotic lesion of up to 28 mm in length in a native coronary artery 2.25 mm to 3.5 mm in diameter. The safety and performance of two different drug release rate formulations of the Evolution Stent will be compared to the commercially available PROMUS (TM) Element (TM) drug-eluting stent.

ReferenceCitation: Meredith IT, Verheye S, Weissman NJ, Barragan P, Scott D, Valdes Chavarri M, West NE, Kelbaek H, Whitbourn R, Walters DL, Kubica J, Thuesen L, Masotti M, Banning A, Sjogren I, Stables RH, Allocco DJ, Dawkins KD. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013 Jul;9(3):308-15. doi: 10.4244/EIJV9I3A52.

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Meredith IT, Verheye S, Weissman NJ, Barragan P, Scott D, Chavarri MV, West NE, Kelbaek H, Whitbourn R, Walters DL, Kubica J, Thuesen L, Masotti M, Banning A, Sjogren I, Stables RH, Allocco DJ, Dawkins KD. Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent. EuroIntervention. 2013 May 22:20130416-02. Online ahead of print.

ReferenceCitation: Meredith IT, Verheye S, Dubois CL, Dens J, Fajadet J, Carrie D, Walsh S, Oldroyd KG, Varenne O, El-Jack S, Moreno R, Joshi AA, Allocco DJ, Dawkins KD. Primary endpoint results of the EVOLVE trial: a randomized evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent. J Am Coll Cardiol. 2012 Apr 10;59(15):1362-70. doi: 10.1016/j.jacc.2011.12.016. Epub 2012 Feb 15.

lead_sponsor: Boston Scientific Corporation

location_country:
Poland
New Zealand
United Kingdom
Denmark
Australia
Sweden
Belgium
Spain
France

location_facility: Rigshospitalet Thoraxkirurgisk Klinik RT

location_facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

intervention_type: Device


title: Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease

acronym: EXPEDITION EXT

summary: This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).

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.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Brazil
Japan
Sweden
United States
Korea, Republic of
Spain
Taiwan
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.


type: Registry Identifier

title: The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)

summary: The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.

ReferenceCitation: Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

ReferenceCitation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

ReferenceCitation: Umpierrez G, Tofe Povedano S, Perez Manghi F, Shurzinske L, Pechtner V. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014 Aug;37(8):2168-76. doi: 10.2337/dc13-2759. Epub 2014 May 19.

publisher_dissemination: American Diabetes Association

location_country:
Finland
Germany
Poland
Argentina
Brazil
Croatia
Canada
France
Czech Republic
Slovakia
United States
India
Romania
Puerto Rico
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa


acronym: GRIPHON OL

lead_sponsor: Actelion

summary: Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

ReferenceCitation: Galie N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2022 Jan;39(1):796-810. doi: 10.1007/s12325-021-01898-1. Epub 2021 Oct 30.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repositories_concat: PubMed Central;cris.unibo.it

title: Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension

location_country:
Germany
Ireland
Poland
Argentina
Australia
Thailand
Turkey
Chile
Czechia
Canada
Serbia
France
Belarus
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Belgium
China
Malaysia
Peru
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


acronym: ADMYRE

lead_sponsor: PharmaMar

summary: Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

title: Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Czechia
France
Portugal
United States
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan


title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating the Pain Palliation Benefit of Adding Custirsen to a Taxane for Second-Line Chemotherapy in Men With Castrate Resistance Prostate Cancer

summary: The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.

lead_sponsor: Achieve Life Sciences

sponsor_collaborators:
Achieve Life Sciences
Teva Pharmaceuticals USA

location_country:
United Kingdom
United States
Spain
Canada
France


title: Palivizumab (Synagis®) Post-marketing Surveillance Cohort Study in Children < 24 Months of Age With Hemodynamically Significant Congenital Heart Disease

summary: Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab

lead_sponsor: Abbott

location_country:
Germany
Italy
Poland
Slovenia
Norway
United Kingdom
Austria
Belgium
Spain
France

location_facility:
Site Reference ID/Investigator# 15702
Site Reference ID/Investigator# 6272
Site Reference ID/Investigator# 12222
Site Reference ID/Investigator# 6274
Site Reference ID/Investigator# 6244
Site Reference ID/Investigator# 14682
Site Reference ID/Investigator#6260
Site Reference ID/Investigator# 6263
Site Reference ID/Investigator# 6270
Site Reference ID/Investigator# 6280
Site Reference ID/Investigator# 8277
Site Reference ID/Investigator# 6275
Site Reference ID/Investigator# 5023
Site Reference ID/Investigator# 13102
Site Reference ID/Investigator# 18602
Site Reference ID/Investigator# 17821
Site Reference ID/Investigator# 16361
Site Reference ID/Investigator# 15261
Site Reference ID/Investigator# 9403
Site Reference ID/Investigator# 5372
Site Reference ID/Investigator# 15381
Site Reference ID/Investigator# 6249
Site Reference ID/Investigator# 6261
Site Reference ID/Investigator# 9621
Site Reference ID/Investigator# 6245
Site Reference ID/Investigator# 6282
Site Reference ID/Investigator# 11182
Site Reference ID/Investigator# 18601
Site Reference ID/Investigator# 14681
Site Reference ID/Investigator# 14802
Site Reference ID/Investigator# 6276
Site Reference ID/Investigator# 4703
Site Reference ID/Investigator# 13941
Site Reference ID/Investigator# 6271
Site Reference ID/Investigator# 6283
Site Reference ID/Investigator# 7956
Site Reference ID/Investigator# 4910


acronym: ALIGN

lead_sponsor: Sanofi

summary:
Primary objective:

- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)

Secondary objectives:

to demonstrate that Sarilumab was effective on:

assessment of higher level of response [ASAS 40% response criteria (ASAS40)]
partial remission
disease activity
range of motion
Magnetic Resonance Imaging (MRI) of the spine
to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS

ReferenceCitation: Sieper J, Braun J, Kay J, Badalamenti S, Radin AR, Jiao L, Fiore S, Momtahen T, Yancopoulos GD, Stahl N, Inman RD. Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN). Ann Rheum Dis. 2015 Jun;74(6):1051-7. doi: 10.1136/annrheumdis-2013-204963. Epub 2014 Feb 18.

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number 276005
Investigational Site Number 840028
Investigational Site Number 276003
Investigational Site Number 724004
Investigational Site Number 840029
Investigational Site Number 036002
Investigational Site Number 124006
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 124007
Investigational Site Number 203002
Investigational Site Number 840018
Investigational Site Number 840036
Investigational Site Number 203003
Investigational Site Number 440001
Investigational Site Number 724005
Investigational Site Number 056003
Investigational Site Number 616003
Investigational Site Number 348001
Investigational Site Number 840013
Investigational Site Number 348005
Investigational Site Number 250002
Investigational Site Number 348003
Investigational Site Number 840002
Investigational Site Number 056004
Investigational Site Number 840001
Investigational Site Number 840023
Investigational Site Number 840014
Investigational Site Number 203005
Investigational Site Number 040001
Investigational Site Number 040002
Investigational Site Number 036003
Investigational Site Number 124002
Investigational Site Number 056005
Investigational Site Number 124003
Investigational Site Number 840017
Investigational Site Number 616002
Investigational Site Number 840021
Investigational Site Number 124010
Investigational Site Number 124004
Investigational Site Number 840009
Investigational Site Number 203004
Investigational Site Number 840030
Investigational Site Number 840032
Investigational Site Number 276002
Investigational Site Number 250005
Investigational Site Number 348004
Investigational Site Number 036004
Investigational Site Number 124008
Investigational Site Number 792001
Investigational Site Number 840006
Investigational Site Number 616005
Investigational Site Number 528001
Investigational Site Number 276001
Investigational Site Number 124005
Investigational Site Number 840033
Investigational Site Number 276004
Investigational Site Number 036001
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840004
Investigational Site Number 792002
Investigational Site Number 840016
Investigational Site Number 056002
Investigational Site Number 724002
Investigational Site Number 124009
Investigational Site Number 203001
Investigational Site Number 616004
Investigational Site Number 616001
Investigational Site Number 840034
Investigational Site Number 840007
Investigational Site Number 250001
Investigational Site Number 124001
Investigational Site Number 440002
Investigational Site Number 528002
Investigational Site Number 840027
Investigational Site Number 840015
Investigational Site Number 840010
Investigational Site Number 840005
Investigational Site Number 056001

title: A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)

location_country:
Germany
Lithuania
Poland
Hungary
Australia
Netherlands
Austria
Belgium
United States
Spain
Turkey
Czechia
Canada
France


lead_sponsor: Janssen Infectious Diseases BVBA

summary: The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

ReferenceCitation: Susser S, Flinders M, Reesink HW, Zeuzem S, Lawyer G, Ghys A, Van Eygen V, Witek J, De Meyer S, Sarrazin C. Evolution of hepatitis C virus quasispecies during repeated treatment with the NS3/4A protease inhibitor telaprevir. Antimicrob Agents Chemother. 2015 May;59(5):2746-55. doi: 10.1128/AAC.04911-14. Epub 2015 Feb 23.

publisher_dissemination: American Society for Microbiology

sponsor_collaborators:
Janssen Infectious Diseases BVBA
Vertex Pharmaceuticals Incorporated

title: An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons

location_country:
Germany
Poland
Israel
United Kingdom
Australia
Brazil
Netherlands
Sweden
Belgium
Switzerland
United States
Spain
Canada
Puerto Rico
France