title: A Randomized, Open-Label Study to Compare the Efficacy and Safety of AT1001 and Enzyme Replacement Therapy (ERT) in Patients With Fabry Disease and AT1001-Responsive GLA Mutations, Who Were Previously Treated With ERT

summary: Study to compare the efficacy and safety of migalastat and enzyme replacement therapy (ERT) in male and female participants with Fabry disease who are currently receiving ERT and who have an alpha galactosidase-A (α Gal-A) mutation that is amenable to migalastat, based on the clinical trial human embryonic kidney cell (HEK) assay.

ReferenceCitation: Feldt-Rasmussen U, Hughes D, Sunder-Plassmann G, Shankar S, Nedd K, Olivotto I, Ortiz D, Ohashi T, Hamazaki T, Skuban N, Yu J, Barth JA, Nicholls K. Long-term efficacy and safety of migalastat treatment in Fabry disease: 30-month results from the open-label extension of the randomized, phase 3 ATTRACT study. Mol Genet Metab. 2020 Sep - Oct;131(1-2):219-228. doi: 10.1016/j.ymgme.2020.07.007. Epub 2020 Aug 15.

ReferenceCitation: Bichet DG, Aerts JM, Auray-Blais C, Maruyama H, Mehta AB, Skuban N, Krusinska E, Schiffmann R. Assessment of plasma lyso-Gb(3) for clinical monitoring of treatment response in migalastat-treated patients with Fabry disease. Genet Med. 2021 Jan;23(1):192-201. doi: 10.1038/s41436-020-00968-z. Epub 2020 Sep 30. Erratum in: Genet Med. 2020 Nov 20;:.

ReferenceCitation: Haninger-Vacariu N, El-Hadi S, Pauler U, Foretnik M, Kain R, Prohászka Z, Schmidt A, Skuban N, Barth JA, Sunder-Plassmann G. Pregnancy Outcome after Exposure to Migalastat for Fabry Disease: A Clinical Report. Case Rep Obstet Gynecol. 2019 Dec 21;2019:1030259. doi: 10.1155/2019/1030259. eCollection 2019.

ReferenceCitation: Narita I, Ohashi T, Sakai N, Hamazaki T, Skuban N, Castelli JP, Lagast H, Barth JA. Efficacy and safety of migalastat in a Japanese population: a subgroup analysis of the ATTRACT study. Clin Exp Nephrol. 2020 Feb;24(2):157-166. doi: 10.1007/s10157-019-01810-w. Epub 2019 Dec 30.

ReferenceCitation: Hughes DA, Nicholls K, Shankar SP, Sunder-Plassmann G, Koeller D, Nedd K, Vockley G, Hamazaki T, Lachmann R, Ohashi T, Olivotto I, Sakai N, Deegan P, Dimmock D, Eyskens F, Germain DP, Goker-Alpan O, Hachulla E, Jovanovic A, Lourenco CM, Narita I, Thomas M, Wilcox WR, Bichet DG, Schiffmann R, Ludington E, Viereck C, Kirk J, Yu J, Johnson F, Boudes P, Benjamin ER, Lockhart DJ, Barlow C, Skuban N, Castelli JP, Barth J, Feldt-Rasmussen U. Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in Fabry disease: 18-month results from the randomised phase III ATTRACT study. J Med Genet. 2017 Apr;54(4):288-296. doi: 10.1136/jmedgenet-2016-104178. Epub 2016 Nov 10. Erratum in: J Med Genet. 2018 Apr 16;:.

ReferenceCitation: Benjamin ER, Della Valle MC, Wu X, Katz E, Pruthi F, Bond S, Bronfin B, Williams H, Yu J, Bichet DG, Germain DP, Giugliani R, Hughes D, Schiffmann R, Wilcox WR, Desnick RJ, Kirk J, Barth J, Barlow C, Valenzano KJ, Castelli J, Lockhart DJ. The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat. Genet Med. 2017 Apr;19(4):430-438. doi: 10.1038/gim.2016.122. Epub 2016 Sep 22.

lead_sponsor: Amicus Therapeutics

location_country:
Denmark
Brazil
United Kingdom
Italy
Austria
Australia
United States
France
Belgium
Japan


type: EudraCT Number

title: Dasatinib (BMS-354825) Combined With SMO Inhibitor (BMS-833923; XL139) in CML With Resistance or Suboptimal Response to a Prior TKI

summary: The purpose of the study is to determine the safety and tolerability of the combination of BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
United Kingdom
Italy
Finland
Canada
United States
France
Germany

location_facility: Sidney Kimmel Cancer Center At Johns Hopkins

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: International Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of KIACTA in Preventing Renal Function Decline in Patients With AA Amyloidosis

summary: The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: C.T. Development America, Inc.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Poland
Russian Federation
Tunisia
India
Israel
Turkey
Sweden
Egypt
Germany
Latvia
Georgia
Estonia
Finland
France
Netherlands

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: National Scientific Center "Institute of cardiology n.a. academician M.D Strazhesko"

location_facility: Municipal Medical & Preventive Institution Donetsk Regional Clinical Territorial Medical Association

location_facility: State Institution "Institute of Nephrology of AMS of Ukraine"

location_facility: Research Institute of Clinical and Experimental Lymphology

location_facility: Karolinska Universitetssjukhuset i Huddinge

location_facility: Kemerovo State Medical Academy of Roszdrav

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Eskisehir Osmangazi University Medical Faculty

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Helsingin yliopistollinen keskussairaala / Meilahti

location_facility: Sverdlovsk Regional Clinical Hospital #1


title: Post-Myocardial Infarction Remodeling Prevention Therapy

acronym: PRomPT

summary: The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.

ReferenceType: derived

ReferenceCitation: Stone GW, Chung ES, Stancak B, Svendsen JH, Fischer TM, Kueffer F, Ryan T, Bax J, Leon A; PRomPT Trial Investigators. Peri-infarct zone pacing to prevent adverse left ventricular remodelling in patients with large myocardial infarction. Eur Heart J. 2016 Feb 1;37(5):484-93. doi: 10.1093/eurheartj/ehv436. Epub 2015 Aug 30.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Denmark
Saudi Arabia
Hungary
United States
France
Germany
Slovakia

location_facility: Hospital of the University of Pennsylvania

location_facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital

intervention_type: Device


title: A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of Pf-03049423 In Subjects With Ischemic Stroke

summary: The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.

status: Terminated

ReferenceCitation: Di Cesare F, Mancuso J, Woodward P, Bednar MM, Loudon PT; A9541004 Stroke Study Group. Phosphodiesterase-5 Inhibitor PF-03049423 Effect on Stroke Recovery: A Double-Blind, Placebo-Controlled Randomized Clinical Trial. J Stroke Cerebrovasc Dis. 2016 Mar;25(3):642-9. doi: 10.1016/j.jstrokecerebrovasdis.2015.11.026. Epub 2015 Dec 28.

lead_sponsor: Pfizer

location_country:
Taiwan
Canada
Czech Republic
Hungary
Korea, Republic of
United States
France
India
Germany
Bulgaria

location_facility: Jose Canedo, M.D., West Georgia Neurology

location_facility: Oklahoma University Health Sciences Center

location_facility: UNC Department of Neurology Stroke Division

location_facility: Massachusetts General Hospital/Department of Neurology

location_facility: Penn State Hershey Rehabilitation Hospital

location_facility: Hallym University Sacred Heart Hospital, Department of Neurology

location_facility: The Methodist Hospital Neurological Institute

location_facility: UMBAL Tsaritsa Yoanna, Klinika po nevrologia

location_facility: Klinikum Rechts der Isar, Neurologische Klinik

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

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

location_facility: Orszagos Idegtudomanyi Intezet, Stroke-ambulancia

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Otdelenie po Nevrologia

location_facility: Voennomeditsinska Akademia - MBAL- Pleven, Otdelenie po Nervni bolesti

location_facility: MBALNP "Sveti Naum" EAD, Klinika za Intenzivno Lechenie na Nervni Bolesti

location_facility: Universitaetsklinikum Essen, Neurologische Klinik

location_facility: Samsung Medical Center, Department of Neurology

location_facility: Dr. Kennessey Albert Korhaz-Rendelointezet, Neurologiai Osztaly

location_facility: Fovarosi Onkormanyzat Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont/Neurologia

location_facility: Medical Research & Health Education Foundation, Inc.

location_facility: Penn State Milton South Hershey Medical Center / Penn State College of Medicine

location_facility: Universitetska mnogoprofilna bolnitsa za aktivno lechenie Aleksandrovska, Klinika po Nevrologia

location_facility: Honvedkorhaz-Allami Egeszsegugyi Kozpont, Ideggyogyaszati Osztaly

location_facility: Investigational Drug Services at OU Medical Center

location_facility: Seoul National University Bundang Hospital, Department of Neurology

location_facility: MBAL "Tokuda Bolnitsa", Otdelenie po nevrologiya

location_facility: Inha University Hospital, Department of Neurology

location_facility: Asan Medical Center, Department of Neurology

location_facility: Chonnam National University Hospital, Department of Neurology

location_facility: Semmelweis Egyetem AOK / Neurologiai Klinika

location_facility: Petz Aladar Megyei Oktato Korhaz, Neurologiai Osztaly

intervention_type: Other

status_simplified: Unknown


type: Other Identifier

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)

summary: The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.

ReferenceCitation: Toro-Domínguez D, Martorell-Marugán J, Martinez-Bueno M, López-Domínguez R, Carnero-Montoro E, Barturen G, Goldman D, Petri M, Carmona-Sáez P, Alarcón-Riquelme ME. Scoring personalized molecular portraits identify Systemic Lupus Erythematosus subtypes and predict individualized drug responses, symptomatology and disease progression. Brief Bioinform. 2022 Sep 20;23(5). pii: bbac332. doi: 10.1093/bib/bbac332.

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:CD007478. doi: 10.1002/14651858.CD007478.pub2.

ReferenceCitation: Li Y, Higgs RE, Hoffman RW, Dow ER, Liu X, Petri M, Wallace DJ, Dörner T, Eastwood BJ, Miller BB, Liu Y. A Bayesian gene network reveals insight into the JAK-STAT pathway in systemic lupus erythematosus. PLoS One. 2019 Dec 2;14(12):e0225651. doi: 10.1371/journal.pone.0225651. eCollection 2019.

ReferenceCitation: Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.

ReferenceCitation: Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. Epub 2016 May 24.

ReferenceCitation: Hoffman RW, Merrill JT, Alarcón-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.

ReferenceCitation: Merrill JT, van Vollenhoven RF, Buyon JP, Furie RA, Stohl W, Morgan-Cox M, Dickson C, Anderson PW, Lee C, Berclaz PY, Dörner T. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):332-40. doi: 10.1136/annrheumdis-2015-207654. Epub 2015 Aug 20.

lead_sponsor: Eli Lilly and Company

location_country:
Serbia
Spain
United Kingdom
United States
Romania
South Africa
Russian Federation
Australia
Tunisia
India
Israel
Mexico
Malaysia
Brazil
Canada
Hungary
Taiwan
Latvia
New Zealand
Ecuador
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.


acronym: OSKIRA - 1

title: (OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

lead_sponsor: AstraZeneca

source: euctr

ReferenceCitation: Kjelgaard-Petersen CF, Platt A, Braddock M, Jenkins MA, Musa K, Graham E, Gantzel T, Slynn G, Weinblatt ME, Karsdal MA, Thudium CS, Bay-Jensen AC. Translational Biomarkers and Ex Vivo Models of Joint Tissues as a Tool for Drug Development in Rheumatoid Arthritis. Arthritis Rheumatol. 2018 Sep;70(9):1419-1428. doi: 10.1002/art.40527. Epub 2018 Jul 24.

location_country:
Poland
Brazil
United Kingdom
Australia
Estonia
Argentina
Mexico
Ukraine
Hungary
United States
Chile
France
India
Belgium
Peru
Bulgaria
Slovakia

summary: The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

lead_sponsor: Debiopharm International SA

location_country:
Poland
Taiwan
Romania
Spain
Italy
United Kingdom
Australia
Hungary
Puerto Rico
United States
France
Turkey
Belgium
Germany

summary: The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.


title: A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma

summary: The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.

study_start_date_type: Actual

lead_sponsor: Celgene

location_country:
United Kingdom
United States
Spain
France

location_facility: NYU Cancer Institute - Bellevue Hospital

location_facility: Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie

location_facility: Mayo Clinic Cancer Clinical Studies Unit

location_facility: Sarah Cannon Research Institute Drug Development Unit

location_facility: University of California, San Francisco Hellen Diller Family Comprehensive Cancer Center


title: An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase Alfa (Human Recombinant Tissue-nonspecific Alkaline Phosphatase Fusion Protein) in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)

lead_sponsor: Alexion Pharmaceuticals

ReferenceCitation: Padidela R, Yates R, Benscoter D, McPhail G, Chan E, Nichani J, Mughal MZ, Myer C 4th, Narayan O, Nissenbaum C, Wilkinson S, Zhou S, Saal HM. Characterization of tracheobronchomalacia in infants with hypophosphatasia. Orphanet J Rare Dis. 2020 Aug 6;15(1):204. doi: 10.1186/s13023-020-01483-9.

ReferenceCitation: Hofmann CE, Harmatz P, Vockley J, Högler W, Nakayama H, Bishop N, Martos-Moreno GÁ, Moseley S, Fujita KP, Liese J, Rockman-Greenberg C; ENB-010-10 Study Group. Efficacy and Safety of Asfotase Alfa in Infants and Young Children With Hypophosphatasia: A Phase 2 Open-Label Study. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2735-2747. doi: 10.1210/jc.2018-02335.

ReferenceCitation: Whyte MP, Rockman-Greenberg C, Ozono K, Riese R, Moseley S, Melian A, Thompson DD, Bishop N, Hofmann C. Asfotase Alfa Treatment Improves Survival for Perinatal and Infantile Hypophosphatasia. J Clin Endocrinol Metab. 2016 Jan;101(1):334-42. doi: 10.1210/jc.2015-3462. Epub 2015 Nov 3.

location_country:
Saudi Arabia
Italy
Russian Federation
Australia
Spain
Canada
United Kingdom
United States
France
Turkey
Japan
Germany

location_facility: Health Sciences Centre Winnipeg, University of Manitoba

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Children's Hospital & Research Center Oakland

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: St. Marianna University School of Medicine, Yokohayama City Seibu Hospital

location_facility: King Faisal Specialist Hospital and Research Center

location_facility: Hospital Infantil Universitario Nino Jesus

summary: This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of a study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion protein) to see what effects it has on patients 5 years of age or less with HPP.


ipd_sharing: Yes

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

lead_sponsor: Amgen

ReferenceType: result

ReferenceCitation: Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO, Wollenhaupt J, Gladman DD, Hochfeld M, Teng LL, Schett G, Lespessailles E, Hall S. Longterm (52-week) results of a phase III randomized, controlled trial of apremilast in patients with psoriatic arthritis. J Rheumatol. 2015 Mar;42(3):479-88. doi: 10.3899/jrheum.140647. Epub 2015 Jan 15.

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.

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, Gómez-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.

ReferenceCitation: Kavanaugh A, Mease PJ, Gomez-Reino JJ, Adebajo AO, Wollenhaupt J, Gladman DD, Lespessailles E, Hall S, Hochfeld M, Hu C, Hough D, Stevens RM, Schett G. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann Rheum Dis. 2014 Jun;73(6):1020-6. doi: 10.1136/annrheumdis-2013-205056. Epub 2014 Mar 4.

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:
Poland
Spain
United Kingdom
Austria
Australia
New Zealand
Canada
Russian Federation
Hungary
United States
France
South Africa
Germany

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: The Center for Rheumatology and Bone Research

location_facility: Dermatology Treatment and Research Center

location_facility: Piedmont Medical Research Associates Inc

location_facility: St. Clare's Health Care Corporation of St. John's

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

location_facility: Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

location_facility: The Arthritis Program Research Group Inc.

location_facility: Ryazan I.P. Pavlov State Medical University

location_facility: Queen Elizabeth Hospital for Rheumatic Disease

location_facility: Honvéd Kórház - Állami Egészségügyi Központ

location_facility: Arthritis and Osteoporosis Associates LLP

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Clinical Research Center of Reading, LLP

location_facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Departmental Hospital at Smolensk Station RZhD JSC

summary: The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.


title: Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea

acronym: STAR

summary: The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.

ReferenceCitation: Johnson MD, Dweiri YM, Cornelius J, Strohl KP, Steffen A, Suurna M, Soose RJ, Coleman M, Rondoni J, Durand DM, Ni Q. Model-based analysis of implanted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Sleep. 2021 Apr 27;44(44 Suppl 1):S11-S19. doi: 10.1093/sleep/zsaa269.

ReferenceCitation: Yu JL, Younes M. Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial. J Clin Sleep Med. 2021 Apr 1;17(4):797-801. doi: 10.5664/jcsm.9050.

ReferenceCitation: Op de Beeck S, Wellman A, Dieltjens M, Strohl KP, Willemen M, Van de Heyning PH, Verbraecken JA, Vanderveken OM, Sands SA; STAR Trial Investigators. Endotypic Mechanisms of Successful Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2021 Mar 15;203(6):746-755. doi: 10.1164/rccm.202006-2176OC.

ReferenceCitation: Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, Van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP; STAR Trial Group. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014 Jan 9;370(2):139-49. doi: 10.1056/NEJMoa1308659.

lead_sponsor: Inspire Medical Systems, Inc.

location_country:
Netherlands
United States
France
Belgium
Germany

location_facility: University of Pittsburgh Medical Center; Montefiore

location_facility: University Hospitals / Case Western Reserve

location_facility: Deparment of Pulmonology Head and Neck Surgery, Universitair Ziekenhuis Antwerpen

location_facility: Clinical Research Group of St. Petersburg, Inc.

location_facility: Wayne State University / Detroit Medical Center


title: CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)

acronym: CONTRAST

summary: The purpose of this study is to determine the diagnostic performances of iodine contrast medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be measured using standard adenosine. We hypothesize that contrast FFR will offer superior diagnostic agreement compared to resting conditions.

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: De Bruyne B, Pijls NH, Barbato E, Bartunek J, Bech JW, Wijns W, Heyndrickx GR. Intracoronary and intravenous adenosine 5'-triphosphate, adenosine, papaverine, and contrast medium to assess fractional flow reserve in humans. Circulation. 2003 Apr 15;107(14):1877-83. Epub 2003 Mar 31.

ReferenceCitation: Johnson NP, Jeremias A, Zimmermann FM, Adjedj J, Witt N, Hennigan B, Koo BK, Maehara A, Matsumura M, Barbato E, Esposito G, Trimarco B, Rioufol G, Park SJ, Yang HM, Baptista SB, Chrysant GS, Leone AM, Berry C, De Bruyne B, Gould KL, Kirkeeide RL, Oldroyd KG, Pijls NHJ, Fearon WF. Continuum of Vasodilator Stress From Rest to Contrast Medium to Adenosine Hyperemia for Fractional Flow Reserve Assessment. JACC Cardiovasc Interv. 2016 Apr 25;9(8):757-767. doi: 10.1016/j.jcin.2015.12.273.

ReferenceCitation: Johnson NP, Matsuo H, Nakayama M, Eftekhari A, Kakuta T, Tanaka N, Christiansen EH, Kirkeeide RL, Gould KL. Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1904-1913. doi: 10.1016/j.jcin.2021.07.041.

ReferenceCitation: Johnson NP, Collet C. Can FFR After Stenting Help Reduce Target Vessel Failure? JACC Cardiovasc Interv. 2021 Sep 13;14(17):1901-1903. doi: 10.1016/j.jcin.2021.08.001.

ReferenceCitation: Gould KL, Johnson NP, Roby AE, Nguyen T, Kirkeeide R, Haynie M, Lai D, Zhu H, Patel MB, Smalling R, Arain S, Balan P, Nguyen T, Estrera A, Sdringola S, Madjid M, Nascimbene A, Loyalka P, Kar B, Gregoric I, Safi H, McPherson D. Regional, Artery-Specific Thresholds of Quantitative Myocardial Perfusion by PET Associated with Reduced Myocardial Infarction and Death After Revascularization in Stable Coronary Artery Disease. J Nucl Med. 2019 Mar;60(3):410-417. doi: 10.2967/jnumed.118.211953. Epub 2018 Aug 16.

ReferenceCitation: Johnson NP, Kirkeeide RL, Gould KL. Same Lesion, Different Artery, Different FFR!? JACC Cardiovasc Imaging. 2019 Apr;12(4):718-721. doi: 10.1016/j.jcmg.2017.11.029. Epub 2018 Jan 17.

ReferenceCitation: Kobayashi Y, Johnson NP, Zimmermann FM, Witt N, Berry C, Jeremias A, Koo BK, Esposito G, Rioufol G, Park SJ, Nishi T, Choi DH, Oldroyd KG, Barbato E, Pijls NHJ, De Bruyne B, Fearon WF; CONTRAST Study Investigators. Agreement of the Resting Distal to Aortic Coronary Pressure With the Instantaneous Wave-Free Ratio. J Am Coll Cardiol. 2017 Oct 24;70(17):2105-2113. doi: 10.1016/j.jacc.2017.08.049.

ReferenceCitation: Nishi T, Johnson NP, De Bruyne B, Berry C, Gould KL, Jeremias A, Oldroyd KG, Kobayashi Y, Choi DH, Pijls NHJ, Fearon WF; CONTRAST Study Investigators. Influence of Contrast Media Dose and Osmolality on the Diagnostic Performance of Contrast Fractional Flow Reserve. Circ Cardiovasc Interv. 2017 Oct;10(10). pii: e004985. doi: 10.1161/CIRCINTERVENTIONS.117.004985.

ReferenceCitation: Matsumura M, Johnson NP, Fearon WF, Mintz GS, Stone GW, Oldroyd KG, De Bruyne B, Pijls NHJ, Maehara A, Jeremias A. Accuracy of Fractional Flow Reserve Measurements in Clinical Practice: Observations From a Core Laboratory Analysis. JACC Cardiovasc Interv. 2017 Jul 24;10(14):1392-1401. doi: 10.1016/j.jcin.2017.03.031.

ReferenceCitation: Gargiulo G, Stabile E, Ferrone M, Barbato E, Zimmermann FM, Adjedj J, Hennigan B, Matsumura M, Johnson NP, Fearon WF, Jeremias A, Trimarco B, Esposito G; CONTRST Study Investigators. Diabetes does not impact the diagnostic performance of contrast-based fractional flow reserve: insights from the CONTRAST study. Cardiovasc Diabetol. 2017 Jan 13;16(1):7. doi: 10.1186/s12933-016-0494-2.

ReferenceCitation: Johnson NP, Gould KL, Di Carli MF, Taqueti VR. Invasive FFR and Noninvasive CFR in the Evaluation of Ischemia: What Is the Future? J Am Coll Cardiol. 2016 Jun 14;67(23):2772-2788. doi: 10.1016/j.jacc.2016.03.584. Review.

ReferenceCitation: Gould KL, Johnson NP. Coronary Blood Flow After Acute MI: Alternative Truths. JACC Cardiovasc Interv. 2016 Mar 28;9(6):614-7. doi: 10.1016/j.jcin.2016.02.009.

ReferenceCitation: Gould KL, Johnson NP. Myocardial Bridges: Lessons in Clinical Coronary Pathophysiology. JACC Cardiovasc Imaging. 2015 Jun;8(6):705-9. doi: 10.1016/j.jcmg.2015.02.013.

ReferenceCitation: Gould KL, Johnson NP, Kaul S, Kirkeeide RL, Mintz GS, Rentrop KP, Sdringola S, Virmani R, Narula J. Patient selection for elective revascularization to reduce myocardial infarction and mortality: new lessons from randomized trials, coronary physiology, and statistics. Circ Cardiovasc Imaging. 2015 May;8(5). pii: e003099. doi: 10.1161/CIRCIMAGING.114.003099. Review.

lead_sponsor: The University of Texas Health Science Center, Houston

location_country:
Portugal
United Kingdom
Italy
Sweden
Korea, Republic of
United States
France
Belgium
Netherlands

location_facility: Seoul National University College of Medicine

lead_sponsor_type: academique


title: Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years

summary: The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Spain
Canada
France


title: A Phase Ib/II, Open Label, Multi-center Study Evaluating the Safety and Efficacy of BKM120 in Combination With Trastuzumab in Patients With Relapsing HER2 Overexpressing Breast Cancer Who Have Previously Failed Trastuzumab

summary:
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.

The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
France
Belgium

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)

location_facility: Sarah Cannon Research Institute Sarah Cannon Cancer Center SC

location_facility: University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr WA Siteman

location_facility: H. Lee Moffitt Cancer Center & Research Institute


title: A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Participants With Moderate to Severe Chronic Plaque-type Psoriasis

location_country:
United States
Israel
France
Norway
Iceland
Japan
Germany

summary: The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.


title: A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease

summary: This is a study to compare the efficacy of IPX066 and CLE in subjects with advanced Parkinson's disease.

ReferenceCitation: Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.

ipd_sharing: No

lead_sponsor: Impax Laboratories, LLC

location_country:
Germany
United States
Italy
France

location_facility: Hôpital Gabriel Montpied-Service de Neurologie A-

location_facility: Parkinson's Disease and Movement Disorders Center of Long Island

location_facility: RKU, Neurologische Klinik der Universität Ulm

location_facility: Service de neurologie-Hôpital de la Timone-

location_facility: Praxis für Neurologie, Psychiatrie und Psychotherapie Achim

location_facility: Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: San Raffaele Cassino, San Raffaele Cassino,

location_facility: USF Parkinson's and Movement Disorders Center


title: A Phase I/II Study of LDE225 in Pediatric Patients With Recurrent or Refractory Medulloblastoma or Other Tumors Potentially Dependent on the Hedgehog-signaling Pathway and Adult Patients With Recurrent or Refractory Medulloblastoma

location_country:
United Kingdom
Italy
Australia
Canada
United States
France

location_facility: Children's Healthcare of Atlanta Childern Hosp - ATL

location_facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. John Hopkins

location_facility: Seattle Children's Hospital CPKC412A2114

summary:
Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling pathway.

Phase II study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory MB.


title: A Phase I Open-label, Dose Escalation Study to Investigate The Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2879552 Given Orally in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma

summary: GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific Demethylase 1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST) activity. This is a phase I, open-label, multi-center, non-randomized, 2-part first time in human (FTIH) study for GSK2879552. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for GSK2879552 based on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) profiles observed after oral administration of GSK2879552. Any dose level(s) may be expanded up to 12 subjects in order to collect additional data on PK and PD.The safety and PK/PD data will be reviewed prior to the dose decision, and the dose escalation will be guided by the Neuenschwander -continuous reassessment method (N-CRM). Built-in safety constraints are in place to prevent exposing subjects to undue risk of toxicity. Once RP2D is identified, an expansion cohort (Part 2) of up to 30 subjects will be enrolled to further evaluate the clinical activity and tolerability of GSK2879552 in subjects with relapsed/refractory SCLC.

ReferenceCitation: Bauer TM, Besse B, Martinez-Marti A, Trigo JM, Moreno V, Garrido P, Ferron-Brady G, Wu Y, Park J, Collingwood T, Kruger RG, Mohammad HP, Ballas MS, Dhar A, Govindan R. Phase I, Open-Label, Dose-Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2879552 in Relapsed/Refractory SCLC. J Thorac Oncol. 2019 Oct;14(10):1828-1838. doi: 10.1016/j.jtho.2019.06.021. Epub 2019 Jun 28.

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
Spain
France


title: A Long-Term Study to Assess the Ongoing Safety and Efficacy of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

summary:
The primary objective of this study is to obtain data regarding the safety of olipudase alfa in patients with acid sphingomyelinase deficiency (ASMD) who are exposed to long term treatment with olipudase alfa.

The secondary objectives of this study are to obtain data regarding the efficacy of olipudase alfa and to characterize olipudase alfa pharmacodynamics (PD) and pharmacokinetics (PK) following long-term administration.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Thurberg BL, Diaz GA, Lachmann RH, Schiano T, Wasserstein MP, Ji AJ, Zaher A, Peterschmitt MJ. Long-term efficacy of olipudase alfa in adults with acid sphingomyelinase deficiency (ASMD): Further clearance of hepatic sphingomyelin is associated with additional improvements in pro- and anti-atherogenic lipid profiles after 42 months of treatment. Mol Genet Metab. 2020 Sep - Oct;131(1-2):245-252. doi: 10.1016/j.ymgme.2020.06.010. Epub 2020 Jun 24.

ReferenceCitation: Wasserstein MP, Diaz GA, Lachmann RH, Jouvin MH, Nandy I, Ji AJ, Puga AC. Olipudase alfa for treatment of acid sphingomyelinase deficiency (ASMD): safety and efficacy in adults treated for 30 months. J Inherit Metab Dis. 2018 Sep;41(5):829-838. doi: 10.1007/s10545-017-0123-6. Epub 2018 Jan 5.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Brazil
United Kingdom
Italy
France
United States
Belgium
Germany

location_facility:
Investigational Site Number 056001
Investigational Site Number 380002
Investigational Site Number 250002
Investigational Site Number 840001
Investigational Site Number 276002
Investigational Site Number 826002
Investigational Site Number 826001
Investigational Site Number 076001
Investigational Site Number 380001

status_simplified: Ongoing


title: An Open-Label, Multi-Center, Dose-Escalation, Phase I Study With an Expansion Phase, to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6895882, an Immunocytokine, Consisting of a Variant of Interleukin-2 (IL-2v) Targeting Carcinoembryonic Antigen (CEA) Administered Intravenously, in Patients With Advanced and/or Metastatic Solid Tumors

summary: This open-label, multi-center, dose-escalation study will evaluate the safety, pharmacokinetics, and therapeutic activity of RO6895882 in participants with Carcinoembryonic Antigen (CEA)-positive solid tumors who have progressed on the standard of care therapy. The study will be conducted in 3 parts. Part 1 will be a single ascending dose study in single participant cohort at low RO6895882 dose (less than or equal to [</=] 6 milligrams [mg]). Part 2 will be a dose-escalation study of RO6895882 monotherapy given every week (qw), every 2 weeks (q2w), and possibly every 3 weeks (q3w). Part 3 will be an expansion phase of the qw, q2w, and possibly q3w at maximum tolerated dose (MTD) (as determined in Part 2). Part 3 will only be conducted if the risk/benefit assessment, as evaluated by the Sponsor and the investigators, is in favor of the participants. Participants will be treated until disease progression, unacceptable toxicity or withdrawal from treatment for other reasons or death for a maximum duration of 24 months.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Spain
United Kingdom
Finland
Switzerland
United States
France
Netherlands

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale


title: An Analysis of Historical Data on Hematological Remission and Survival Among Adult Patients With Relapsed / Refractory B-Precursor Acute Lymphoblastic Leukemia

summary: A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.

time_perspective: Retrospective

ReferenceCitation: Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21.

ReferenceCitation: Gökbuget N, Dombret H, Ribera JM, Fielding AK, Advani A, Bassan R, Chia V, Doubek M, Giebel S, Hoelzer D, Ifrah N, Katz A, Kelsh M, Martinelli G, Morgades M, O'Brien S, Rowe JM, Stieglmaier J, Wadleigh M, Kantarjian H. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2016 Dec;101(12):1524-1533. Epub 2016 Sep 1.

location_country:
Poland
Spain
Italy
United Kingdom
United States
France
Germany
Czechia


type: U.S. FDA Grant/Contract

title: Extension Study of XLHED-Affected Male Subjects Treated With EDI200 in Protocol ECP-002

summary: The goal of the ECP-002e extension study is to continue the evaluation of all EDI200-treated ECP-002 subjects up to age 10 yrs. No additional study drug administration is planned. The efficacy evaluations will incorporate growth and development parameters, frequency of infections and hospitalizations, and age-appropriate assessments of ectoderm-derived organ function. The safety evaluations will include physical examinations, adverse events and concomitant medication documentation, and laboratory testing. Funding Source - FDA OOPD

ipd_sharing: Undecided

lead_sponsor: Edimer Pharmaceuticals

location_country:
United Kingdom
Italy
United States
France
Germany

location_facility: Azienda Ospedaliera-Polo Universitario "Luigi Sacco"

location_facility: Washington University School of Medicine


title: Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry

summary: The primary objective of the study is to prospectively evaluate pregnancy outcomes in women with multiple sclerosis who were exposed to a Registry-specified Biogen Multiple Sclerosis product during the eligibility window for that product. The Registry-specified Biogen MS products being studied are dimethyl fumarate, and Pegylated human interferon beta-1a. The secondary objective of the study is to prospectively evaluate pregnancy outcomes in women with MS who were unexposed to disease-modifying therapies (DMTs).

ReferenceCitation: Hellwig K, Rog D, McGuigan C, Houtchens MK, Bruen DR, Mokliatchouk O, Branco F, Peng X, Everage NJ. Interim Analysis of Pregnancy Outcomes After Exposure to Dimethyl Fumarate in a Prospective International Registry. Neurol Neuroimmunol Neuroinflamm. 2021 Nov 23;9(1). pii: e1114. doi: 10.1212/NXI.0000000000001114. Print 2022 Jan.

lead_sponsor: Biogen

location_country:
Poland
Spain
Ireland
Italy
Australia
United Kingdom
Canada
United States
France
Germany


title: Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

acronym: ODYSSEY OLE

summary:
Primary Objective:

To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).

Secondary Objectives:

To evaluate the long-term efficacy of alirocumab on lipid parameters.
To evaluate the long-term immunogenicity of alirocumab.

ReferenceCitation: Dufour R, Hovingh GK, Guyton JR, Langslet G, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial. J Clin Lipidol. 2019 Jan - Feb;13(1):138-147. doi: 10.1016/j.jacl.2018.11.007. Epub 2018 Nov 30.

ReferenceCitation: Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Guyton JR. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307-314. doi: 10.1016/j.atherosclerosis.2018.08.036. Epub 2018 Sep 1.

ReferenceCitation: Hovingh GK, Guyton JR, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2018 Nov - Dec;12(6):1463-1470. doi: 10.1016/j.jacl.2018.08.011. Epub 2018 Aug 30.

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
United States
Romania
South Africa
Belgium
Czechia
Portugal
Austria
Russian Federation
Argentina
Israel
Mexico
Norway
Sweden
Canada
Hungary
Germany
Bulgaria
Denmark
Finland
France
Netherlands

location_facility:
Investigational Site Number 840329
Investigational Site Number 840353
Investigational Site Number 826317
Investigational Site Number 246301
Investigational Site Number 826310
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title: A Randomized Parallel-group, Placebo-controlled, Double-blind, Multi-center Dose Finding Phase II Trial Exploring the Pharmacodynamic Effects, Safety and Tolerability, and Pharmacokinetics of Four Dose Regimens of the Oral sGC Stimulator BAY1021189 Over 12 Weeks in Patients With Worsening Heart Failure With Reduced Ejection Fraction (HFrEF)

summary: Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

ReferenceCitation: Pieske B, Butler J, Filippatos G, Lam C, Maggioni AP, Ponikowski P, Shah S, Solomon S, Kraigher-Krainer E, Samano ET, Scalise AV, Müller K, Roessig L, Gheorghiade M; SOCRATES Investigators and Coordinators. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES). Eur J Heart Fail. 2014 Sep;16(9):1026-38. doi: 10.1002/ejhf.135. Epub 2014 Jul 24.

ReferenceCitation: Gheorghiade M, Greene SJ, Butler J, Filippatos G, Lam CS, Maggioni AP, Ponikowski P, Shah SJ, Solomon SD, Kraigher-Krainer E, Samano ET, Müller K, Roessig L, Pieske B; SOCRATES-REDUCED Investigators and Coordinators. Effect of Vericiguat, a Soluble Guanylate Cyclase Stimulator, on Natriuretic Peptide Levels in Patients With Worsening Chronic Heart Failure and Reduced Ejection Fraction: The SOCRATES-REDUCED Randomized Trial. JAMA. 2015 Dec 1;314(21):2251-62. doi: 10.1001/jama.2015.15734.

ReferenceCitation: Ruehs H, Klein D, Frei M, Grevel J, Austin R, Becker C, Roessig L, Pieske B, Garmann D, Meyer M. Population Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. Clin Pharmacokinet. 2021 Nov;60(11):1407-1421. doi: 10.1007/s40262-021-01024-y. Epub 2021 Jun 4.

ReferenceCitation: Kramer F, Voss S, Roessig L, Igl BW, Butler J, Lam CSP, Maggioni AP, Shah SJ, Pieske B. Evaluation of high-sensitivity C-reactive protein and uric acid in vericiguat-treated patients with heart failure with reduced ejection fraction. Eur J Heart Fail. 2020 Sep;22(9):1675-1683. doi: 10.1002/ejhf.1787. Epub 2020 Mar 25.

lead_sponsor: Bayer

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Israel
Sweden
Singapore
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands


title: COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term Dual Anti-Platelet Therapy. The PzF Shield Trial

summary: This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.

lead_sponsor: CeloNova BioSciences, Inc.

location_country:
Serbia
Spain
Latvia
Switzerland
United States
France
Germany

location_facility: Oklahoma Foundation for Cardiovascular Research

location_facility: Paul Stradins Clinical University Hospital

location_facility: San Antonio Endovascular & Heart Institute


title: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

summary: To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

ReferenceCitation: Grossberg GT, Kohegyi E, Mergel V, Josiassen MK, Meulien D, Hobart M, Slomkowski M, Baker RA, McQuade RD, Cummings JL. Efficacy and Safety of Brexpiprazole for the Treatment of Agitation in Alzheimer's Dementia: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled Trials. Am J Geriatr Psychiatry. 2020 Apr;28(4):383-400. doi: 10.1016/j.jagp.2019.09.009. Epub 2019 Oct 1.

ipd_sharing_description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Slovenia
United Kingdom
Russian Federation
Finland
Canada
Ukraine
United States
France
Bulgaria


acronym: Refametinib in RAS mutant HCC

title: A Prospective, Single-arm, Multicenter, Uncontrolled, Open-label Phase II Trial of Refametinib (BAY86-9766) in Patients With RAS Mutant Hepatocellular Carcinoma (HCC)

location_country:
Taiwan
Hong Kong
Spain
Italy
Austria
New Zealand
United Kingdom
Thailand
Switzerland
Hungary
Korea, Republic of
France
United States
Belgium
Japan
Germany
Czechia

summary:
This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review.

Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.


title: A Phase 1/2, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation

summary:
The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are:

To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies.
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies.

The primary objective of Phase 2 is:

• To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.

ReferenceCitation: Stein EM, DiNardo CD, Pollyea DA, Fathi AT, Roboz GJ, Altman JK, Stone RM, DeAngelo DJ, Levine RL, Flinn IW, Kantarjian HM, Collins R, Patel MR, Frankel AE, Stein A, Sekeres MA, Swords RT, Medeiros BC, Willekens C, Vyas P, Tosolini A, Xu Q, Knight RD, Yen KE, Agresta S, de Botton S, Tallman MS. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017 Aug 10;130(6):722-731. doi: 10.1182/blood-2017-04-779405. Epub 2017 Jun 6.

ReferenceCitation: Fathi AT, DiNardo CD, Kline I, Kenvin L, Gupta I, Attar EC, Stein EM, de Botton S; AG221-C-001 Study Investigators. Differentiation Syndrome Associated With Enasidenib, a Selective Inhibitor of Mutant Isocitrate Dehydrogenase 2: Analysis of a Phase 1/2 Study. JAMA Oncol. 2018 Aug 1;4(8):1106-1110. doi: 10.1001/jamaoncol.2017.4695.

ReferenceCitation: Stein EM, DiNardo CD, Fathi AT, Pollyea DA, Stone RM, Altman JK, Roboz GJ, Patel MR, Collins R, Flinn IW, Sekeres MA, Stein AS, Kantarjian HM, Levine RL, Vyas P, MacBeth KJ, Tosolini A, VanOostendorp J, Xu Q, Gupta I, Lila T, Risueno A, Yen KE, Wu B, Attar EC, Tallman MS, de Botton S. Molecular remission and response patterns in patients with mutant-IDH2 acute myeloid leukemia treated with enasidenib. Blood. 2019 Feb 14;133(7):676-687. doi: 10.1182/blood-2018-08-869008. Epub 2018 Dec 3.

ReferenceCitation: Pollyea DA, Tallman MS, de Botton S, Kantarjian HM, Collins R, Stein AS, Frattini MG, Xu Q, Tosolini A, See WL, MacBeth KJ, Agresta SV, Attar EC, DiNardo CD, Stein EM. Enasidenib, an inhibitor of mutant IDH2 proteins, induces durable remissions in older patients with newly diagnosed acute myeloid leukemia. Leukemia. 2019 Nov;33(11):2575-2584. doi: 10.1038/s41375-019-0472-2. Epub 2019 Apr 9.

ReferenceCitation: Quek L, David MD, Kennedy A, Metzner M, Amatangelo M, Shih A, Stoilova B, Quivoron C, Heiblig M, Willekens C, Saada V, Alsafadi S, Vijayabaskar MS, Peniket A, Bernard OA, Agresta S, Yen K, MacBeth K, Stein E, Vassiliou GS, Levine R, De Botton S, Thakurta A, Penard-Lacronique V, Vyas P. Clonal heterogeneity of acute myeloid leukemia treated with the IDH2 inhibitor enasidenib. Nat Med. 2018 Aug;24(8):1167-1177. doi: 10.1038/s41591-018-0115-6. Epub 2018 Jul 16.

ReferenceCitation: Amatangelo MD, Quek L, Shih A, Stein EM, Roshal M, David MD, Marteyn B, Farnoud NR, de Botton S, Bernard OA, Wu B, Yen KE, Tallman MS, Papaemmanuil E, Penard-Lacronique V, Thakurta A, Vyas P, Levine RL. Enasidenib induces acute myeloid leukemia cell differentiation to promote clinical response. Blood. 2017 Aug 10;130(6):732-741. doi: 10.1182/blood-2017-04-779447. Epub 2017 Jun 6.

ReferenceCitation: Shih AH, Meydan C, Shank K, Garrett-Bakelman FE, Ward PS, Intlekofer AM, Nazir A, Stein EM, Knapp K, Glass J, Travins J, Straley K, Gliser C, Mason CE, Yen K, Thompson CB, Melnick A, Levine RL. Combination Targeted Therapy to Disrupt Aberrant Oncogenic Signaling and Reverse Epigenetic Dysfunction in IDH2- and TET2-Mutant Acute Myeloid Leukemia. Cancer Discov. 2017 May;7(5):494-505. doi: 10.1158/2159-8290.CD-16-1049. Epub 2017 Feb 13.

ReferenceCitation: Stein EM, Fathi AT, DiNardo CD, Pollyea DA, Roboz GJ, Collins R, Sekeres MA, Stone RM, Attar EC, Frattini MG, Tosolini A, Xu Q, See WL, MacBeth KJ, de Botton S, Tallman MS, Kantarjian HM. Enasidenib in patients with mutant IDH2 myelodysplastic syndromes: a phase 1 subgroup analysis of the multicentre, AG221-C-001 trial. Lancet Haematol. 2020 Apr;7(4):e309-e319. doi: 10.1016/S2352-3026(19)30284-4. Epub 2020 Mar 5.

ReferenceCitation: Intlekofer AM, Shih AH, Wang B, Nazir A, Rustenburg AS, Albanese SK, Patel M, Famulare C, Correa FM, Takemoto N, Durani V, Liu H, Taylor J, Farnoud N, Papaemmanuil E, Cross JR, Tallman MS, Arcila ME, Roshal M, Petsko GA, Wu B, Choe S, Konteatis ZD, Biller SA, Chodera JD, Thompson CB, Levine RL, Stein EM. Acquired resistance to IDH inhibition through trans or cis dimer-interface mutations. Nature. 2018 Jul;559(7712):125-129. doi: 10.1038/s41586-018-0251-7. Epub 2018 Jun 27.

ReferenceCitation: Stein EM. Enasidenib, a targeted inhibitor of mutant IDH2 proteins for treatment of relapsed or refractory acute myeloid leukemia. Future Oncol. 2018 Jan;14(1):23-40. doi: 10.2217/fon-2017-0392. Epub 2017 Sep 18.

ReferenceCitation: de Botton S, Brandwein JM, Wei AH, Pigneux A, Quesnel B, Thomas X, Legrand O, Recher C, Chantepie S, Hunault-Berger M, Boissel N, Nehme SA, Frattini MG, Tosolini A, Marion-Gallois R, Wang JJ, Cameron C, Siddiqui M, Hutton B, Milkovich G, Stein EM. Improved survival with enasidenib versus standard of care in relapsed/refractory acute myeloid leukemia associated with IDH2 mutations using historical data and propensity score matching analysis. Cancer Med. 2021 Sep;10(18):6336-6343. doi: 10.1002/cam4.4182. Epub 2021 Aug 24.

lead_sponsor: Celgene

location_country:
United States
France

location_facility: Oregon Health and Science University OHSU

location_facility: University of Miami Sylvester Cancer Center

location_facility: Cornell University Weill Medical College

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Sarah Cannon Research Institute Drug Development Unit

location_facility: Memorial Sloan-Kettering Cancer Center - NYC


title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.

summary:
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).

ReferenceCitation: Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Mądry R, Christensen RD, Berek JS, Dørum A, Tinker AV, du Bois A, González-Martín A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016 Dec 1;375(22):2154-2164. Epub 2016 Oct 7.

ReferenceCitation: Tattersall A, Ryan N, Wiggans AJ, Rogozińska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2:CD007929. doi: 10.1002/14651858.CD007929.pub4. Review.

ReferenceCitation: Mirza MR, Benigno B, Dørum A, Mahner S, Bessette P, Barceló IB, Berton-Rigaud D, Ledermann JA, Rimel BJ, Herrstedt J, Lau S, du Bois A, Herráez AC, Kalbacher E, Buscema J, Lorusso D, Vergote I, Levy T, Wang P, de Jong FA, Gupta D, Matulonis UA. Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial. Gynecol Oncol. 2020 Nov;159(2):442-448. doi: 10.1016/j.ygyno.2020.09.006. Epub 2020 Sep 25.

ReferenceCitation: Matulonis UA, Walder L, Nøttrup TJ, Bessette P, Mahner S, Gil-Martin M, Kalbacher E, Ledermann JA, Wenham RM, Woie K, Lau S, Marmé F, Casado Herraez A, Hardy-Bessard AC, Banerjee S, Lindahl G, Benigno B, Buscema J, Travers K, Guy H, Mirza MR. Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Dec 1;37(34):3183-3191. doi: 10.1200/JCO.19.00917. Epub 2019 Sep 16.

ReferenceCitation: Del Campo JM, Matulonis UA, Malander S, Provencher D, Mahner S, Follana P, Waters J, Berek JS, Woie K, Oza AM, Canzler U, Gil-Martin M, Lesoin A, Monk BJ, Lund B, Gilbert L, Wenham RM, Benigno B, Arora S, Hazard SJ, Mirza MR. Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. J Clin Oncol. 2019 Nov 10;37(32):2968-2973. doi: 10.1200/JCO.18.02238. Epub 2019 Jun 7.

ReferenceCitation: Oza AM, Matulonis UA, Malander S, Hudgens S, Sehouli J, Del Campo JM, Berton-Rigaud D, Banerjee S, Scambia G, Berek JS, Lund B, Tinker AV, Hilpert F, Vázquez IP, D'Hondt V, Benigno B, Provencher D, Buscema J, Agarwal S, Mirza MR. Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2018 Aug;19(8):1117-1125. doi: 10.1016/S1470-2045(18)30333-4. Epub 2018 Jul 17.

ReferenceCitation: Berek JS, Matulonis UA, Peen U, Ghatage P, Mahner S, Redondo A, Lesoin A, Colombo N, Vergote I, Rosengarten O, Ledermann J, Pineda M, Ellard S, Sehouli J, Gonzalez-Martin A, Berton-Rigaud D, Madry R, Reinthaller A, Hazard S, Guo W, Mirza MR. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 1;29(8):1784-1792. doi: 10.1093/annonc/mdy181. Erratum in: Ann Oncol. 2019 May 1;30(5):859.

lead_sponsor: Tesaro, Inc.

location_country:
Denmark
Poland
Spain
Italy
Austria
United Kingdom
Canada
Sweden
Hungary
United States
France
Israel
Belgium
Norway
Germany


acronym: ASTRA

title: A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients With Differentiated Thyroid Cancer

lead_sponsor: AstraZeneca

ReferenceCitation: Ho AL, Dedecjus M, Wirth LJ, Tuttle RM, Inabnet WB 3rd, Tennvall J, Vaisman F, Bastholt L, Gianoukakis AG, Rodien P, Paschke R, Elisei R, Viola D, So K, Carroll D, Hovey T, Thakre B, Fagin JA; ASTRA investigator group. Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA). J Clin Oncol. 2022 Jun 10;40(17):1870-1878. doi: 10.1200/JCO.21.00714. Epub 2022 Feb 22.

location_country:
Denmark
Poland
Brazil
Italy
Sweden
United States
France
Germany

summary: The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.


title: A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia

summary:
Background:

- Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.

ReferenceCitation: Bouroncle BA. Thirty-five years in the progress of hairy cell leukemia. Leuk Lymphoma. 1994;14 Suppl 1:1-12. Review.

ReferenceCitation: Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66.

ReferenceCitation: Sharpe RW, Bethel KJ. Hairy cell leukemia: diagnostic pathology. Hematol Oncol Clin North Am. 2006 Oct;20(5):1023-49. Review.

ReferenceCitation: Kreitman RJ, Tallman MS, Robak T, Coutre S, Wilson WH, Stetler-Stevenson M, Fitzgerald DJ, Lechleider R, Pastan I. Phase I trial of anti-CD22 recombinant immunotoxin moxetumomab pasudotox (CAT-8015 or HA22) in patients with hairy cell leukemia. J Clin Oncol. 2012 May 20;30(15):1822-8. doi: 10.1200/JCO.2011.38.1756. Epub 2012 Feb 21.

ReferenceCitation: Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Karlin L, Robak T, Gladstone DE, le Coutre P, Dietrich S, Gotic M, Larratt L, Offner F, Schiller G, Swords R, Bacon L, Bocchia M, Bouabdallah K, Breems DA, Cortelezzi A, Dinner S, Doubek M, Gjertsen BT, Gobbi M, Hellmann A, Lepretre S, Maloisel F, Ravandi F, Rousselot P, Rummel M, Siddiqi T, Tadmor T, Troussard X, Yi CA, Saglio G, Roboz GJ, Balic K, Standifer N, He P, Marshall S, Wilson W, Pastan I, Yao NS, Giles F. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018 Aug;32(8):1768-1777. doi: 10.1038/s41375-018-0210-1. Epub 2018 Jul 20.

ReferenceCitation: Kreitman RJ, Dearden C, Zinzani PL, Delgado J, Robak T, le Coutre PD, Gjertsen BT, Troussard X, Roboz GJ, Karlin L, Gladstone DE, Kuptsova-Clarkson N, Liu S, Patel P, Rotolo F, Mitry E, Pastan I, Giles F; Study 1053 investigators. Moxetumomab pasudotox in heavily pre-treated patients with relapsed/refractory hairy cell leukemia (HCL): long-term follow-up from the pivotal trial. J Hematol Oncol. 2021 Feb 24;14(1):35. doi: 10.1186/s13045-020-01004-y.

ReferenceCitation: Abou Dalle I, Ravandi F. Moxetumomab pasudotox for the treatment of relapsed and/or refractory hairy cell leukemia. Expert Rev Hematol. 2019 Sep;12(9):707-714. doi: 10.1080/17474086.2019.1643231. Epub 2019 Aug 1. Review.

lead_sponsor: MedImmune LLC

location_country:
Poland
Serbia
Spain
Ireland
Italy
United Kingdom
Canada
France
United States
Israel
Belgium
Norway
Germany
Czechia


title: A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients With Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations

lead_sponsor: Puma Biotechnology, Inc.

location_facility: Hopitaux universitaires de Strasbourg Nouvel Hopital Civil

location_facility: CHU de Grenoble Hopital Albert Michallon

location_facility: University of Pittsburgh Cancer Institute

summary: This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.


title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Parallel-group Study to Determine the Effects of Evolocumab (AMG 145) Treatment on Atherosclerotic Disease Burden as Measured by Intravascular Ultrasound in Subjects Undergoing Coronary Catheterization

acronym: GLAGOV

summary: This study will evaluate whether low-density lipoprotein (LDL-C) lowering with evolocumab (AMG 145) results in greater change from baseline in percent atheroma volume (PAV) at week 78 than placebo in adults with coronary artery disease taking lipid lowering therapy.

ReferenceCitation: Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJ, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Scott R, Ungi I, Podolec J, Ophuis AO, Cornel JH, Borgman M, Brennan DM, Nissen SE. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA. 2016 Dec 13;316(22):2373-2384. doi: 10.1001/jama.2016.16951.

ReferenceCitation: Nicholls SJ, Puri R, Anderson T, Ballantyne CM, Cho L, Kastelein JJP, Koenig W, Somaratne R, Kassahun H, Yang J, Wasserman SM, Honda S, Shishikura D, Scherer DJ, Borgman M, Brennan DM, Wolski K, Nissen SE. Effect of Evolocumab on Coronary Plaque Composition. J Am Coll Cardiol. 2018 Oct 23;72(17):2012-2021. doi: 10.1016/j.jacc.2018.06.078.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

ReferenceCitation: Puri R, Nissen SE, Somaratne R, Cho L, Kastelein JJ, Ballantyne CM, Koenig W, Anderson TJ, Yang J, Kassahun H, Wasserman SM, Scott R, Borgman M, Nicholls SJ. Impact of PCSK9 inhibition on coronary atheroma progression: Rationale and design of Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV). Am Heart J. 2016 Jun;176:83-92. doi: 10.1016/j.ahj.2016.01.019. Epub 2016 Feb 17.

lead_sponsor: Amgen

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Iceland
Philippines
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Chile
Netherlands

intervention_type: Biological


title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

acronym: TRANSPORT

summary: The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

ReferenceCitation: Flume PA, Suthoff ED, Kosinski M, Marigowda G, Quittner AL. Measuring recovery in health-related quality of life during and after pulmonary exacerbations in patients with cystic fibrosis. J Cyst Fibros. 2019 Sep;18(5):737-742. doi: 10.1016/j.jcf.2018.12.004. Epub 2018 Dec 23.

ReferenceCitation: McColley SA, Konstan MW, Ramsey BW, Stuart Elborn J, Boyle MP, Wainwright CE, Waltz D, Vera-Llonch M, Marigowda G, Jiang JG, Rubin JL. Lumacaftor/Ivacaftor reduces pulmonary exacerbations in patients irrespective of initial changes in FEV(1). J Cyst Fibros. 2019 Jan;18(1):94-101. doi: 10.1016/j.jcf.2018.07.011. Epub 2018 Aug 23.

ReferenceCitation: Elborn JS, Ramsey BW, Boyle MP, Konstan MW, Huang X, Marigowda G, Waltz D, Wainwright CE; VX-809 TRAFFIC and TRANSPORT study groups. Efficacy and safety of lumacaftor/ivacaftor combination therapy in patients with cystic fibrosis homozygous for Phe508del CFTR by pulmonary function subgroup: a pooled analysis. Lancet Respir Med. 2016 Aug;4(8):617-626. doi: 10.1016/S2213-2600(16)30121-7. Epub 2016 Jun 10.

ReferenceCitation: Wainwright CE, Elborn JS, Ramsey BW, Marigowda G, Huang X, Cipolli M, Colombo C, Davies JC, De Boeck K, Flume PA, Konstan MW, McColley SA, McCoy K, McKone EF, Munck A, Ratjen F, Rowe SM, Waltz D, Boyle MP; TRAFFIC Study Group; TRANSPORT Study Group. Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. N Engl J Med. 2015 Jul 16;373(3):220-31. doi: 10.1056/NEJMoa1409547. Epub 2015 May 17.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Denmark
Spain
United Kingdom
Austria
Australia
Canada
United States
France
Belgium
Germany


acronym: TRAFFIC

location_country:
United Kingdom
Ireland
Italy
Australia
Netherlands
Canada
Czech Republic
Sweden
United States
France
Germany


title: A 12-Week Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX(R) 160/4.5 mcg Inhalation Powder Versus SYMBICORT(R) TURBOHALER(R) 200/6 mcg in Adult and Adolescent Patients With Persistent Asthma

summary: The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.

ReferenceCitation: Virchow JC, Rodriguez-Roisin R, Papi A, Shah TP, Gopalan G. A randomized, double-blinded, double-dummy efficacy and safety study of budesonide-formoterol Spiromax® compared to budesonide-formoterol Turbuhaler® in adults and adolescents with persistent asthma. BMC Pulm Med. 2016 Mar 17;16:42. doi: 10.1186/s12890-016-0200-x.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

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

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
Russian Federation
Finland
United Kingdom
Sweden
Hungary
France
Israel
Belgium
Germany
Czechia

location_facility:
Teva Investigational Site 50174
Teva Investigational Site 80039
Teva Investigational Site 35088
Teva Investigational Site 30056
Teva Investigational Site 80037
Teva Investigational Site 32250
Teva Investigational Site 54056
Teva Investigational Site 32257
Teva Investigational Site 40003
Teva Investigational Site 80041
Teva Investigational Site 42014
Teva Investigational Site 31056
Teva Investigational Site 31055
Teva Investigational Site 30055
Teva Investigational Site 38049
Teva Investigational Site 34022
Teva Investigational Site 40002
Teva Investigational Site 32240
Teva Investigational Site 53120
Teva Investigational Site 54064
Teva Investigational Site 32258
Teva Investigational Site 40001
Teva Investigational Site 50178
Teva Investigational Site 39020
Teva Investigational Site 39021
Teva Investigational Site 32256
Teva Investigational Site 38048
Teva Investigational Site 53105
Teva Investigational Site 33020
Teva Investigational Site 54067
Teva Investigational Site 34026
Teva Investigational Site 32241
Teva Investigational Site 50179
Teva Investigational Site 53107
Teva Investigational Site 31054
Teva Investigational Site 53106
Teva Investigational Site 33018
Teva Investigational Site 35091
Teva Investigational Site 54063
Teva Investigational Site 31061
Teva Investigational Site 31058
Teva Investigational Site 54061
Teva Investigational Site 51074
Teva Investigational Site 32246
Teva Investigational Site 32254
Teva Investigational Site 35090
Teva Investigational Site 51076
Teva Investigational Site 53110
Teva Investigational Site 53103
Teva Investigational Site 54065
Teva Investigational Site 32249
Teva Investigational Site 50172
Teva Investigational Site 53111
Teva Investigational Site 42012
Teva Investigational Site 35093
Teva Investigational Site 53104
Teva Investigational Site 35089
Teva Investigational Site 53100
Teva Investigational Site 51072
Teva Investigational Site 32259
Teva Investigational Site 51073
Teva Investigational Site 50175
Teva Investigational Site 51067
Teva Investigational Site 32251
Teva Investigational Site 51077
Teva Investigational Site 54068
Teva Investigational Site 80040
Teva Investigational Site 34024
Teva Investigational Site 80036
Teva Investigational Site 31052
Teva Investigational Site 34029
Teva Investigational Site 53113
Teva Investigational Site 53119
Teva Investigational Site 51068
Teva Investigational Site 40005
Teva Investigational Site 34028
Teva Investigational Site 51075
Teva Investigational Site 50177
Teva Investigational Site 53101
Teva Investigational Site 32252
Teva Investigational Site 32253
Teva Investigational Site 30054
Teva Investigational Site 51065
Teva Investigational Site 53109
Teva Investigational Site 54059
Teva Investigational Site 53114
Teva Investigational Site 33019
Teva Investigational Site 50171
Teva Investigational Site 31057
Teva Investigational Site 32247
Teva Investigational Site 32243
Teva Investigational Site 53115
Teva Investigational Site 34027
Teva Investigational Site 37030
Teva Investigational Site 80038
Teva Investigational Site 54058
Teva Investigational Site 53099
Teva Investigational Site 40004
Teva Investigational Site 32255
Teva Investigational Site 35092
Teva Investigational Site 51070
Teva Investigational Site 53116
Teva Investigational Site 31053
Teva Investigational Site 37031
Teva Investigational Site 42011
Teva Investigational Site 37029
Teva Investigational Site 51071
Teva Investigational Site 80035
Teva Investigational Site 31051
Teva Investigational Site 50170
Teva Investigational Site 53102
Teva Investigational Site 50173
Teva Investigational Site 32244
Teva Investigational Site 53117


title: A Phase I/II Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) Antibody-radionuclide-conjugate for Treatment of Relapsed Non-Hodgkin Lymphoma.

summary: This study is a phase I/II open-label study in patients with relapsed indolent NHL (Part A) or relapsed/refractory FL (Part B). Part A of the study assessed the safety and preliminary efficacy. This seamless design study now has four parts: 1) Part A, Ph I - dose escalation, 2) Part A, Ph II - dose expansion, 3) Part B, Ph II randomized - refinement of dose, and 4) Part B and C, Phase II, single-arm. As of August 7, 2020, patients are enrolling in the fourth part of the study.

ReferenceCitation: Dahle J, Repetto-Llamazares AH, Mollatt CS, Melhus KB, Bruland OS, Kolstad A, Larsen RH. Evaluating antigen targeting and anti-tumor activity of a new anti-CD37 radioimmunoconjugate against non-Hodgkin's lymphoma. Anticancer Res. 2013 Jan;33(1):85-95.

ReferenceCitation: Repetto-Llamazares AH, Larsen RH, Mollatt C, Lassmann M, Dahle J. Biodistribution and dosimetry of (177)Lu-tetulomab, a new radioimmunoconjugate for treatment of non-Hodgkin lymphoma. Curr Radiopharm. 2013 Mar;6(1):20-7.

ReferenceCitation: Løndalen A, Blakkisrud J, Revheim ME, Madsbu UE, Dahle J, Kolstad A, Stokke C. FDG PET/CT parameters and correlations with tumor-absorbed doses in a phase 1 trial of (177)Lu-lilotomab satetraxetan for treatment of relapsed non-Hodgkin lymphoma. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1902-1914. doi: 10.1007/s00259-020-05098-x. Epub 2020 Nov 16.

ReferenceCitation: Kolstad A, Illidge T, Bolstad N, Spetalen S, Madsbu U, Stokke C, Blakkisrud J, Løndalen A, O'Rourke N, Beasley M, Jurczak W, Fagerli UM, Kaščák M, Bayne M, Obr A, Dahle J, Rojkjaer L, Pascal V, Holte H. Phase 1/2a study of 177Lu-lilotomab satetraxetan in relapsed/refractory indolent non-Hodgkin lymphoma. Blood Adv. 2020 Sep 8;4(17):4091-4101. doi: 10.1182/bloodadvances.2020002583.

lead_sponsor: Nordic Nanovector

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Austria
Australia
Israel
Turkey
Norway
Sweden
Singapore
Canada
Switzerland
Hungary
Denmark
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: Eskisehir Osmangazi Universitesi Tip Fakultesi Ic Hastaliklar

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

location_facility: SS Antonio & Biagio and C. Arrigo Hospital

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: "Istituto di Ematologia ed Oncologia Medica "" L. & A. Seragnoli""-Policlinico S. Orsola Malpighi"

location_facility: Universita Degli Studi Di Firenze-Azienda Ospedaliero-Universitaria Careggi (AOUC)

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi Ic

location_facility: Health Research Institute La Fe - Hospital La Fe

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: Orszagos Onkologiai Intezet, A-Belgyogyaszati Onkologiai Osztaly

location_facility: "Istituto Nazionale Tumori Fondazione G. Pascale"

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Helsinki University Hospital Comprehensive Cancer Center

location_facility: Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Medizinische Universität Wien - AKH Wien, Universitaetsklinik fuer Innere Medizin I

location_facility: Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau

location_facility: Semmelweis Egyetem, I Belgyogyaszati Klinika, Hematologiai Osztaly

location_facility: University Of Arkansas For Medical Sciences

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS

location_facility: University of California, San Francisco (UCSF)

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Cukurova Universitesi Tip Fakültesi, Ic Hastaliklari Anabilim Dali


title: A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis

summary: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.

ReferenceCitation: Stone JH, Spotswood H, Unizony SH, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Spiera R, Bao M. New-onset versus relapsing giant cell arteritis treated with tocilizumab: 3-year results from a randomized controlled trial and extension. Rheumatology (Oxford). 2022 Jul 6;61(7):2915-2922. doi: 10.1093/rheumatology/keab780.

ReferenceCitation: Unizony SH, Bao M, Han J, Luder Y, Pavlov A, Stone JH. Treatment failure in giant cell arteritis. Ann Rheum Dis. 2021 Nov;80(11):1467-1474. doi: 10.1136/annrheumdis-2021-220347. Epub 2021 May 28.

ReferenceCitation: Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schulze-Koops H, Schett G, Spiera R, Unizony SH, Collinson N. Glucocorticoid Dosages and Acute-Phase Reactant Levels at Giant Cell Arteritis Flare in a Randomized Trial of Tocilizumab. Arthritis Rheumatol. 2019 Aug;71(8):1329-1338. doi: 10.1002/art.40876. Epub 2019 Jul 3.

ReferenceCitation: Strand V, Dimonaco S, Tuckwell K, Klearman M, Collinson N, Stone JH. Health-related quality of life in patients with giant cell arteritis treated with tocilizumab in a phase 3 randomised controlled trial. Arthritis Res Ther. 2019 Feb 20;21(1):64. doi: 10.1186/s13075-019-1837-7.

ReferenceCitation: Stone JH, Tuckwell K, Dimonaco S, Klearman M, Aringer M, Blockmans D, Brouwer E, Cid MC, Dasgupta B, Rech J, Salvarani C, Schett G, Schulze-Koops H, Spiera R, Unizony SH, Collinson N. Trial of Tocilizumab in Giant-Cell Arteritis. N Engl J Med. 2017 Jul 27;377(4):317-328. doi: 10.1056/NEJMoa1613849.

location_country:
Denmark
Poland
Portugal
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Haywood Hospital; Staffordshire Rheumatology Centre

location_facility: University of Utah; Division of Rheumatology

location_facility: Royal Cornwall Hospital; Rhuematololgy Dept

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Klinische Immunologie und Rheumatologie

location_facility: Rheumazentrum-Ruhrgebiet, St. Josefs-Krankenhaus; Rheumatologie

location_facility: Asheville Arthritis & Osteoporosis Center, PA

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

location_facility: Rikshospitalet; Revmatologisk Avd Seksjon Barnerevmatologi

location_facility: University of Barcelona; Dept. of Internal Medicine,

location_facility: Hospital Universitari de Bellvitge; Servicio de Reumatologia

location_facility: Southend Hospital; Rheumatology Department

location_facility: Rheuma-Klinikum Bad Bramstedt Klinik fuer Rheumatologie und Immunologie

location_facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie

location_facility: Klinika Reumatologii I Chorób Wewn. Pum W Szczecinie; Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Old Queen Elizabeth Hospital; Pharmacy Building;Clinical Research offices

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: Hospital de Basurto; Servicio de Reumatologia

location_facility: Policlinico Univ. Uni Degli Sudi Di Udine; Clinica Di Reumatologia

location_facility: University of Edinburgh; The Queens Medical Research Institute

location_facility: Univ of Calif., Los Angeles; Rheumatology

location_facility: Karolinska Sjukhuset; Reumatologkliniken D2-1

location_facility: Rheumatology Assoc. of S. Florida - Clinical Research Center

location_facility: Hospital For Special Surgery; Dept of Medicine - Rheumatology

location_facility: Hospital Geral de Santo Antonio; Servico de Imunologia Clinica

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin III

location_facility: Nordsjællands Hospital - Hillerød;Department of Rheumatology 0731

location_facility: Hopital Claude Huriez; Internal Medicine

location_facility: Akademisch Ziekenhuis St. Radboud; Rheumatology

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela

location_facility: Akademiska Sjukhuset; Lungmedicinska Kliniken

location_facility: Skånes Universitetssjukhus Malmö; Reumatologkliniken

location_facility: Colchester General Hospital; Aseptic Dept, Pharmacy Support Unit

location_facility: Hospital Universitario de Canarias;servicio de Reumatologia

location_facility: Azienda Ospedaliera di Padova; Cattedra e Divisione di Reumatologia

location_facility: Irccs San Raffele; Div Med Gen Immunologia Clinica

location_facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Università Degli Studi Di Genova - Dimi; Reumatologia

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 3; Rheumatologie und Immunologie

location_facility: CHAPEL ALLERTON HOSPITAL; Unit of Musculoskeletal Disease

location_facility: Kreiskliniken Esslingen gGmbH Klinik Plochingen Medizinische Klinik