title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This study is designed to assess the efficacy and safety of etelcalcetide (AMG 416) compared with placebo in the treatment of SHPT in CKD patients receiving hemodialysis.

ReferenceCitation: Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.

ReferenceCitation: Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.

ReferenceCitation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.

ReferenceCitation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.

ReferenceCitation: Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Ureña-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.

ReferenceCitation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.

ReferenceCitation: Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
Sweden
Hungary
United States
France
Israel
Belgium
Germany
Czechia


type: EudraCT Number

title: A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH

summary:
This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo.

PRIMARY OBJECTIVE:

To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with DUODART, compared to men treated with placebo .

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Roehrborn CG, Manyak MJ, Palacios-Moreno JM, Wilson TH, Roos EPM, Santos JC, Karanastasis D, Plastino J, Giuliano F, Rosen RC. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. 2018 Apr;121(4):647-658. doi: 10.1111/bju.14057. Epub 2017 Nov 16.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country: Spain Greece Australia Netherlands Hungary France Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)

acronym: TURANDOT II

summary: Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Shire

location_country:
Serbia
Spain
Italy
United States
South Africa
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Slovakia
Canada
Hungary
Germany
Bulgaria
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Washington University School of Medicine

location_facility: Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica

location_facility: The Oregon Clinic-West Hills Gastroenterology Associates, P.C.

location_facility: Hamilton Health Sciences Corp, McMaster Univ Medical Centre

location_facility: Milan University, Humanitas Clinical Institute

location_facility: Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem

location_facility: Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica

location_facility: Clinical Hospital Centre Bezanijska Kosa

location_facility: Azienda Ospedaliera Universitaria, Policlinico Tor Vergata

location_facility: Universita' degli Studi "Magna Graecia" di Catanzaro

location_facility: St. Petersburg State Medical Academy for Postgraduate Education

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

location_facility: Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1

location_facility: UCSD Altman Clinical and Translational Research Institute

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: University Medical Center Groningen (UMCG)

location_facility: Hepato-Gastroenterologie HK s.r.o. Poliklinika III

location_facility: Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit

location_facility: Klinika Chorob Wewnetrznych I Gastroenterologii

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: Weill Cornell Medical College of Cornell University

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Centro Medico Teknon-Institut de la Macula i de la Retina

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Baylor College Of Medicine - Baylor Medical Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

location_facility: Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.

location_facility: London Health Sciences Centre - University Hospital

location_facility: Policlinico Universitario Campus Bio-Medico


title: Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies

summary: The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

primary_purpose: Prevention

ReferenceCitation: Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macías G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, López-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6. Erratum in: Lancet Infect Dis. 2020 Jan;20(1):e1.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Hong Kong
Russian Federation
Australia
Turkey
Panama
Sweden
Singapore
Canada
Taiwan
New Zealand
Finland
Korea, Republic of
France
Pakistan

intervention_type: Biological


title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-risk Kidney Allograft Recipients

summary: This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preemptive approach for prevention of CMV disease. Participants will be randomized into two treatment groups: active or placebo control; both arms will be followed preemptively. The study has a planned enrollment of approximately 120 participants (60 active and 60 placebo).

ReferenceCitation: Deng R, Wang Y, Maia M, Burgess T, McBride JM, Liao XC, Tavel JA, Hanley WD. Pharmacokinetics and Exposure-Response Analysis of RG7667, a Combination of Two Anticytomegalovirus Monoclonal Antibodies, in a Phase 2a Randomized Trial To Prevent Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2018 Jan 25;62(2). pii: e01108-17. doi: 10.1128/AAC.01108-17. Print 2018 Feb.

ReferenceCitation: Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2017 Jan 24;61(2). pii: e01794-16. doi: 10.1128/AAC.01794-16. Print 2017 Feb.

lead_sponsor: Genentech, Inc.

location_country:
Spain
United Kingdom
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Henry Ford Health System; Gastroenterology

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

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Georgetown Uni Hospital; Division of Transplant Surgery

location_facility: Washington Uni School of Medicine/Barnes Jewish Hospital; Renal

location_facility: Akademiska Sjukhuset; Transplantation Surgery

location_facility: Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie

location_facility: University of Cincinnati / University of Cincinnati College of Medicine

location_facility: Erie County Medical Center; Dept. of Nephrology

location_facility: University of Colorado Health Sciences Center; Dept of Medicine

location_facility: CHU de Nantes; Institut de transplantation urologie-néphrologie

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Hopital Rangueil; Gastro Enterologie Et Nutrition

location_facility: Univ of CA San Francisco; Kidney Transplant Service


status: Terminated

title: A Double-Blind, Placebo-Controlled, Randomized, Two-stage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment With an Inhibitor of the Renin-Angiotensin System

lead_sponsor: Bristol-Myers Squibb

source: euctr

location_country:
Denmark
United States
Canada
France

location_facility: John H. Stroger, Jr. Hospital Of Cook County

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Health Sciences Centre Diabetes Research Centre

location_facility: Va Nebraska-Western Iowa Health Care System (Nwihcs)

location_facility: The Ohio State University Wexner Medical Center

location_facility: Northeast Clinical Research Of San Antonio, Llc

location_facility: George Washington University Medical Faculty Associates

location_facility: Lmc Diabetes & Endocrinology (Thornhill)

summary: The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease

status_simplified: Unknown


acronym: MAGNITUDE

title: A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin

design_allocation: Non-Randomized

location_country:
Spain
Italy
Russian Federation
Australia
United States
France
Romania
Netherlands

location_facility: Hospital Of The University Of Pennsylvania

summary: The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

summary: To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.

ReferenceCitation: Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6). pii: 18m12680. doi: 10.4088/JCP.18m12680.

ReferenceCitation: Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Serbia
Russian Federation
Canada
United States
France
Germany


title: A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease

summary: This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on study treatment is 144 weeks.

location_country:
Spain
United Kingdom
Canada
United States
France
Germany

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: University of British Columbia Hospital; Division of Neurology

location_facility: Royal Sussex County Hospital, CIRU Level 5

location_facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

location_facility: Univ Berlin; Klin fur Psychi & Psycho Charite

location_facility: West London Research Unit; Brentford Lodge

location_facility: Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.

location_facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Clinica Ruber, 4 planta; Servicio de Neurologia

location_facility: Florida Atlantic University; College of Medicine

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

location_facility: University of California Davis Medical System

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: The National Hospital for Neurology & Neurosurgery; Dementia Research Center

location_facility: University of California Los Angeles (UCLA)

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Investigational Drug Service; Univ of Rochester Medical Ctr

location_facility: Moorgreen Hospital; Memory Assessment & Rsch Ctr

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: University of Rochester Medical Center; Monroe Community Hospital

location_facility: Great Western Hosp.; Kingshill Research Ctr

location_facility: Miami Jewish Health Systems; Clinical Research

location_facility: Toronto Memory Program (Neurology Research Inc.)


title: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

acronym: CheckMate 066

summary: The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

ReferenceCitation: Robert C, Long GV, Brady B, Dutriaux C, Di Giacomo AM, Mortier L, Rutkowski P, Hassel JC, McNeil CM, Kalinka EA, Lebbé C, Charles J, Hernberg MM, Savage KJ, Chiarion-Sileni V, Mihalcioiu C, Mauch C, Arance A, Cognetti F, Ny L, Schmidt H, Schadendorf D, Gogas H, Zoco J, Re S, Ascierto PA, Atkinson V. Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma. J Clin Oncol. 2020 Nov 20;38(33):3937-3946. doi: 10.1200/JCO.20.00995. Epub 2020 Sep 30.

ReferenceCitation: Ascierto PA, Long GV, Robert C, Brady B, Dutriaux C, Di Giacomo AM, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebbé C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Ny L, Arance A, Svane IM, Schadendorf D, Gogas H, Saci A, Jiang J, Rizzo J, Atkinson V. Survival Outcomes in Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma Treated With Nivolumab Therapy: Three-Year Follow-up of a Randomized Phase 3 Trial. JAMA Oncol. 2019 Feb 1;5(2):187-194. doi: 10.1001/jamaoncol.2018.4514. Erratum in: JAMA Oncol. 2019 Feb 1;5(2):271.

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

ReferenceCitation: Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Márquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.

ReferenceCitation: Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebbé C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Arance A, Schmidt H, Schadendorf D, Gogas H, Lundgren-Eriksson L, Horak C, Sharkey B, Waxman IM, Atkinson V, Ascierto PA. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015 Jan 22;372(4):320-30. doi: 10.1056/NEJMoa1412082. Epub 2014 Nov 16.

location_country: Denmark Poland Spain Greece Italy Australia Argentina Canada Finland Sweden France Chile Israel Mexico Norway Germany

location_facility: Instituto Medico Especialazado Alexander Fleming


title: A Three-arm, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Two Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) Who Have Refractory Partial-onset Seizures

summary:
This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures.

The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week 18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had completed the core phase] and Post Extension phase [from end of Extension phase to end of study].

ReferenceCitation: Curatolo P, Franz DN, Lawson JA, Yapici Z, Ikeda H, Polster T, Nabbout R, de Vries PJ, Dlugos DJ, Fan J, Ridolfi A, Pelov D, Voi M, French JA. Adjunctive everolimus for children and adolescents with treatment-refractory seizures associated with tuberous sclerosis complex: post-hoc analysis of the phase 3 EXIST-3 trial. Lancet Child Adolesc Health. 2018 Jul;2(7):495-504. doi: 10.1016/S2352-4642(18)30099-3. Epub 2018 May 24.

ReferenceCitation: French JA, Lawson JA, Yapici Z, Ikeda H, Polster T, Nabbout R, Curatolo P, de Vries PJ, Dlugos DJ, Berkowitz N, Voi M, Peyrard S, Pelov D, Franz DN. Adjunctive everolimus therapy for treatment-resistant focal-onset seizures associated with tuberous sclerosis (EXIST-3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet. 2016 Oct 29;388(10056):2153-2163. doi: 10.1016/S0140-6736(16)31419-2. Epub 2016 Sep 6.

ReferenceCitation: Goyer I, Dahdah N, Major P. Use of mTOR inhibitor everolimus in three neonates for treatment of tumors associated with tuberous sclerosis complex. Pediatr Neurol. 2015 Apr;52(4):450-3. doi: 10.1016/j.pediatrneurol.2015.01.004. Epub 2015 Jan 14.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Russian Federation
Australia
Argentina
Turkey
Mexico
Norway
Canada
Hungary
Germany
Denmark
Taiwan
Greece
Ireland
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Washington University School of Medicine SC-2

location_facility: University of California at Los Angeles SC

location_facility: Cincinnati Children's Hospital Medical Center SC

location_facility: Texas Scottish Rite Hospital for Children Texas Scottish

location_facility: The University of Texas Medical School-Houston SC

location_facility: Oregon Health and Science University SC - 3


title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins

summary: This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.

ReferenceType: background

ReferenceCitation: Moriarty PM, Jacobson TA, Bruckert E, Thompson PD, Guyton JR, Baccara-Dinet MT, Gipe D. Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial. J Clin Lipidol. 2014 Nov-Dec;8(6):554-561. doi: 10.1016/j.jacl.2014.09.007. Epub 2014 Sep 19.

ReferenceType: result

ReferenceCitation: Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, Bruckert E, Jacobson TA, Kopecky SL, Baccara-Dinet MT, Du Y, Pordy R, Gipe DA; ODYSSEY ALTERNATIVE Investigators. Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial. J Clin Lipidol. 2015 Nov-Dec;9(6):758-769. doi: 10.1016/j.jacl.2015.08.006. Epub 2015 Aug 29.

ReferenceCitation: Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

ReferenceCitation: Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, Bruckert E, Jacobson TA, Baccara-Dinet MT, Zhao J, Donahue S, Ali S, Manvelian G, Pordy R. Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial. J Clin Lipidol. 2020 Jan - Feb;14(1):88-97.e2. doi: 10.1016/j.jacl.2020.01.001. Epub 2020 Jan 13.

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

ReferenceCitation: Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov - Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. Erratum in: J Clin Lipidol. 2020 Sep - Oct;14(5):742.

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. Epub 2016 Oct 24.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
United Kingdom
Italy
Austria
Canada
United States
Israel
France
Norway


title: Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures

acronym: VERO

summary: The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.

ReferenceCitation: Body JJ, Marin F, Kendler DL, Zerbini CAF, López-Romero P, Möricke R, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Minisola S, Geusens P. Efficacy of teriparatide compared with risedronate on FRAX(®)-defined major osteoporotic fractures: results of the VERO clinical trial. Osteoporos Int. 2020 Oct;31(10):1935-1942. doi: 10.1007/s00198-020-05463-4. Epub 2020 May 30.

ReferenceCitation: Geusens P, Kendler DL, Fahrleitner-Pammer A, López-Romero P, Marin F. Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial. Calcif Tissue Int. 2020 Jun;106(6):646-654. doi: 10.1007/s00223-020-00683-6. Epub 2020 Mar 10.

ReferenceCitation: Minisola S, Marin F, Kendler DL, Geusens P, Zerbini CAF, Russo LA, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Moericke R, Bagur A, Lakatos P, López-Romero P, Body JJ. Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. Arch Osteoporos. 2019 Jan 18;14(1):10. doi: 10.1007/s11657-019-0561-x.

ReferenceCitation: Geusens P, Marin F, Kendler DL, Russo LA, Zerbini CA, Minisola S, Body JJ, Lespessailles E, Greenspan SL, Bagur A, Stepan JJ, Lakatos P, Casado E, Moericke R, López-Romero P, Fahrleitner-Pammer A. Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial. J Bone Miner Res. 2018 May;33(5):783-794. doi: 10.1002/jbmr.3384. Epub 2018 Feb 9.

ReferenceCitation: Kendler DL, Marin F, Zerbini CAF, Russo LA, Greenspan SL, Zikan V, Bagur A, Malouf-Sierra J, Lakatos P, Fahrleitner-Pammer A, Lespessailles E, Minisola S, Body JJ, Geusens P, Möricke R, López-Romero P. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2018 Jan 20;391(10117):230-240. doi: 10.1016/S0140-6736(17)32137-2. Epub 2017 Nov 9. Erratum in: Lancet. 2017 Nov 30;:. Erratum in: Lancet. 2018 Dec 1;392(10162):2352.

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:
Poland
Brazil
Spain
Greece
Austria
Italy
Argentina
Canada
Hungary
Puerto Rico
United States
France
Belgium
Germany
Czechia

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: TELESTAR (Telotristat Etiprate for Somatostatin Analogue Refractory Carcinoid Syndrome)

title: A Phase 3, Randomized, Placebo-controlled, Parallel Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy

lead_sponsor: Lexicon Pharmaceuticals

ReferenceCitation: Srirajaskanthan R, Pavel M, Kulke M, Clement D, Houchard A, Keeber L, Weickert MO. Weight Maintenance up to 48 Weeks in Patients With Carcinoid Syndrome Treated With Telotristat Ethyl: Pooled Data From the Open-Label Extensions of the Phase III Clinical Trials TELESTAR and TELECAST. Clin Ther. 2021 Oct;43(10):1779-1785. doi: 10.1016/j.clinthera.2021.08.014. Epub 2021 Sep 28.

ReferenceCitation: Fust K, Maschio M, Kohli M, Singh S, Pritchard DM, Marteau F, Myrenfors P, Feuilly M. A Budget Impact Model of the Addition of Telotristat Ethyl Treatment to the Standard of Care in Patients with Uncontrolled Carcinoid Syndrome. Pharmacoeconomics. 2020 Jun;38(6):607-618. doi: 10.1007/s40273-020-00896-5.

ReferenceCitation: Dillon JS, Kulke MH, Hörsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2.

ReferenceCitation: Hudgens S, Ramage J, Kulke M, Bergsland E, Anthony L, Caplin M, Öberg K, Pavel M, Gable J, Banks P, Yang QM, Lapuerta P. Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome. J Patient Rep Outcomes. 2019 Oct 26;3(1):64. doi: 10.1186/s41687-019-0153-y.

ReferenceCitation: Cella D, Beaumont JL, Hudgens S, Marteau F, Feuilly M, Houchard A, Lapuerta P, Ramage J, Pavel M, Hörsch D, Kulke MH. Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR. Clin Ther. 2018 Dec;40(12):2006-2020.e2. doi: 10.1016/j.clinthera.2018.10.008. Epub 2018 Nov 24.

ReferenceCitation: Weickert MO, Kaltsas G, Hörsch D, Lapuerta P, Pavel M, Valle JW, Caplin ME, Bergsland E, Kunz PL, Anthony LB, Grande E, Öberg K, Welin S, Lombard-Bohas C, Ramage JK, Kittur A, Yang QM, Kulke MH. Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome. Clin Ther. 2018 Jun;40(6):952-962.e2. doi: 10.1016/j.clinthera.2018.04.006. Epub 2018 May 1.

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

location_facility:
Lexicon Investigational Site
Lexicon Invetigational Site

summary: The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.


title: A Double-blind, Placebo-controlled, Randomized Trial to Study the Viaskin Peanut's Efficacy and Safety for Treating Peanut Allergy in Children and Adults.

acronym: VIPES

summary:
The objectives of this dose-finding study for the treatment of peanut allergy are:

To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment.
To evaluate the safety of a long-term treatment with Viaskin Peanut.

ReferenceCitation: Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10.

ReferenceCitation: Sampson HA, Shreffler WG, Yang WH, Sussman GL, Brown-Whitehorn TF, Nadeau KC, Cheema AS, Leonard SA, Pongracic JA, Sauvage-Delebarre C, Assa'ad AH, de Blay F, Bird JA, Tilles SA, Boralevi F, Bourrier T, Hébert J, Green TD, Gerth van Wijk R, Knulst AC, Kanny G, Schneider LC, Kowalski ML, Dupont C. Effect of Varying Doses of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity: A Randomized Clinical Trial. JAMA. 2017 Nov 14;318(18):1798-1809. doi: 10.1001/jama.2017.16591.

lead_sponsor: DBV Technologies

location_country:
Poland
Canada
United States
France
Netherlands

location_facility: Centre de Recherche Appliquée en Asthme et Allergie de Québec

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of California, Rady Childrens Hospital

location_facility: Ottawa Allergy Asthma Research Institute

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin


title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients With Bipolar I Disorder

summary: The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.

lead_sponsor: OPKO Health, Inc.

location_country:
Poland
Spain
Canada
United States
France
Turkey
Romania
Bulgaria
Czechia


title: Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous Infusion in Patients Suffering From Acute Decompensated Heart Failure [TRUE-AHF]

acronym: TRUE-AHF

summary: The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).

ReferenceCitation: Mitrovic V, Lüss H, Nitsche K, Forssmann K, Maronde E, Fricke K, Forssmann WG, Meyer M. Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: a double-blind, placebo-controlled, ascending-dose trial. Am Heart J. 2005 Dec;150(6):1239.

ReferenceCitation: Mitrovic V, Seferovic PM, Simeunovic D, Ristic AD, Miric M, Moiseyev VS, Kobalava Z, Nitsche K, Forssmann WG, Lüss H, Meyer M. Haemodynamic and clinical effects of ularitide in decompensated heart failure. Eur Heart J. 2006 Dec;27(23):2823-32. Epub 2006 Oct 30.

ReferenceCitation: Packer M, O'Connor C, McMurray JJV, Wittes J, Abraham WT, Anker SD, Dickstein K, Filippatos G, Holcomb R, Krum H, Maggioni AP, Mebazaa A, Peacock WF, Petrie MC, Ponikowski P, Ruschitzka F, van Veldhuisen DJ, Kowarski LS, Schactman M, Holzmeister J; TRUE-AHF Investigators. Effect of Ularitide on Cardiovascular Mortality in Acute Heart Failure. N Engl J Med. 2017 May 18;376(20):1956-1964. doi: 10.1056/NEJMoa1601895. Epub 2017 Apr 12.

ReferenceCitation: Packer M, Holcomb R, Abraham WT, Anker S, Dickstein K, Filippatos G, Krum H, Maggioni AP, McMurray JJV, Mebazaa A, O'Connor C, Peacock F, Ponikowski P, Ruschitzka F, van Veldhuisen DJ, Holzmeister J; TRUE-AHF Investigators and Committees. Rationale for and design of the TRUE-AHF trial: the effects of ularitide on the short-term clinical course and long-term mortality of patients with acute heart failure. Eur J Heart Fail. 2017 May;19(5):673-681. doi: 10.1002/ejhf.698. Epub 2016 Nov 13.

lead_sponsor: Cardiorentis

location_country:
Serbia
Spain
Italy
Lithuania
United States
Romania
Belgium
Czechia
Poland
Argentina
Israel
Turkey
Brazil
Canada
Switzerland
Hungary
Germany
Latvia
Estonia
Finland
France
Netherlands


title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

summary: The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

ReferenceCitation: Hughes R, Dalakas MC, Merkies I, Latov N, Léger JM, Nobile-Orazio E, Sobue G, Genge A, Cornblath D, Merschhemke M, Ervin CM, Agoropoulou C, Hartung HP; FORCIDP Trial Investigators. Oral fingolimod for chronic inflammatory demyelinating polyradiculoneuropathy (FORCIDP Trial): a double-blind, multicentre, randomised controlled trial. Lancet Neurol. 2018 Aug;17(8):689-698. doi: 10.1016/S1474-4422(18)30202-3. Epub 2018 Jul 9. Erratum in: Lancet Neurol. 2018 Nov;17(11):933.

ipd_sharing: Undecided

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
Canada
United Kingdom
United States
France
Israel
Belgium
Japan
Germany
Czechia


title: Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

acronym: RECOURSE

summary: The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

ReferenceCitation: Yoshino T, Cleary JM, Van Cutsem E, Mayer RJ, Ohtsu A, Shinozaki E, Falcone A, Yamazaki K, Nishina T, Garcia-Carbonero R, Komatsu Y, Baba H, Argilés G, Tsuji A, Sobrero A, Yamaguchi K, Peeters M, Muro K, Zaniboni A, Sugimoto N, Shimada Y, Tsuji Y, Hochster HS, Moriwaki T, Tran B, Esaki T, Hamada C, Tanase T, Benedetti F, Makris L, Yamashita F, Lenz HJ. Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials. Ann Oncol. 2020 Jan;31(1):88-95. doi: 10.1016/j.annonc.2019.10.005.

ReferenceCitation: Van Cutsem E, Mayer RJ, Laurent S, Winkler R, Grávalos C, Benavides M, Longo-Munoz F, Portales F, Ciardiello F, Siena S, Yamaguchi K, Muro K, Denda T, Tsuji Y, Makris L, Loehrer P, Lenz HJ, Ohtsu A; RECOURSE Study Group. The subgroups of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo with best supportive care in patients with metastatic colorectal cancer. Eur J Cancer. 2018 Feb;90:63-72. doi: 10.1016/j.ejca.2017.10.009. Epub 2017 Dec 21.

ReferenceCitation: Longo-Muñoz F, Argiles G, Tabernero J, Cervantes A, Gravalos C, Pericay C, Gil-Calle S, Mizuguchi H, Carrato-Mena A, Limón ML, Garcia-Carbonero R. Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial. Clin Transl Oncol. 2017 Feb;19(2):227-235. doi: 10.1007/s12094-016-1528-7. Epub 2016 Jul 21.

ReferenceCitation: Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.

lead_sponsor: Taiho Oncology, Inc.

location_country:
Spain
Ireland
Austria
Australia
Italy
United Kingdom
Sweden
United States
France
Belgium
Japan
Germany
Czechia

location_facility: Staedtisches Klinikum Muenchen / Klinikum Neuperlach

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Institute of Oncology and Rehabilitation Ples

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Medizinische Klinik am Krankenhaus Nordwest GmbH

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital General Universitario de Valencia

location_facility: Seconda Universita degli Studi de Napoli

location_facility: KKR Sapporo Medical Center TONAN-Hospital

location_facility: University College London Hospitals Foundation NHS Trust

location_facility: Fondazione IRCCS Instituto Nazionale dei Tumori Milano

location_facility: Fundacion Jimenez Diaz - Universidad Autonoma de Madrid

location_facility: Hospital Universitario Morales Messeguer

location_facility: Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)

location_facility: Hickman Cancer Center at Flower Hospital

location_facility: Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Klinikum der Universität München - Großhadern

location_facility: Hematology/Oncology Associates of Fredericksburg

location_facility: Universitatsklinikum Carl Gustav Carus - Dresden

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: California Cancer Associates for Research and Excellence

location_facility: Leuven University Hospital - Campus Gasthuiseberg


acronym: BRIGHTER

intervention_type: Procedure

title: A 24-month, Phase IIIb, Open-label, Randomized, Active Controlled, 3-arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy or With Adjunctive Laser Photocoagulation in Comparison to Laser Photocoagulation in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

ReferenceCitation: Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.

ReferenceCitation: Tadayoni R, Waldstein SM, Boscia F, Gerding H, Gekkieva M, Barnes E, Das Gupta A, Wenzel A, Pearce I; BRIGHTER Study Group. Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study. Ophthalmology. 2017 Dec;124(12):1778-1787. doi: 10.1016/j.ophtha.2017.06.027. Epub 2017 Aug 12. Erratum in: Ophthalmology. 2018 Mar;125(3):463.

ReferenceCitation: Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S, Wenzel A, Barnes E, Gekkieva M, Pilz S, Monés J; BRIGHTER study group. Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER. Ophthalmology. 2016 Jun;123(6):1332-44. doi: 10.1016/j.ophtha.2016.02.030. Epub 2016 Mar 30.

location_country:
Denmark
Poland
Portugal
Spain
Greece
Ireland
Australia
Italy
Canada
Czech Republic
Switzerland
United Kingdom
Sweden
Hungary
France
Netherlands
Slovakia

summary: This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.


title: A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin

acronym: PEDESTAL

summary: The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

ReferenceCitation: Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7. Review.

location_country:
Poland
Brazil
Spain
Italy
Austria
Russian Federation
United Kingdom
Canada
Switzerland
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Va Greater Los Angeles Healthcare System

location_facility: Gastrointestinal Specialists Of Georgia Pc

location_facility: University Of California, San Francisco/Sf General Hospital

location_facility: Birmingham Gastroenterology Associates, P.C.

location_facility: Liver And Intestinal Research Centre (Lair)

location_facility: Infectious Disease Research Institute, Inc.

location_facility: Gastrointestinal Research Institute (G.I.R.I.)

location_facility: Bon Secours St. Mary'S Hospital Of Richmond, Inc.


title: A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection

acronym: Hallmark QUAD

summary: The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.

ReferenceCitation: Jensen D, Sherman KE, Hézode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018. Epub 2015 Feb 19.

location_country:
Denmark
Taiwan
Spain
Italy
Russian Federation
Netherlands
Argentina
Canada
Switzerland
Sweden
Korea, Republic of
United States
France
Mexico
Germany

location_facility: University Of Colorado Denver And Hospital

location_facility: University Of Miami Schiff Center For Liver Diseases

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center

location_facility: University Of North Carolina At Chapel Hill School Of Med


title: Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310

lead_sponsor: United Therapeutics

location_country:
United Kingdom
Italy
United States
Poland
Austria
Australia
Argentina
India
Israel
Mexico
Sweden
Singapore
Brazil
Canada
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Chile
Netherlands

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Sentara Cardiovascular Research Institute

location_facility: University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program

location_facility: Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH

location_facility: Hospital das Clinicas da Universidade Federal de Goias

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu

location_facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Centre Hospitalier Universitaire Hopital Nord

location_facility: The Second Affiliated Hospital of Nanchang Medical University

location_facility: Perelman Center for Advanced Medicine, University of Pennsylvania

location_facility: Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: The University of Texas Health Science Center at Houston

location_facility: General Hospital of Thessaloniki, "G.Papanikolaou"

location_facility: The Chaim Sheba Medical Center at Tel Hashomer

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Complexo Hospitalar Santa Casa de Porto Alegre

location_facility: Shanghai Pulmonary Hospital of Tongji University

location_facility: University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine

location_facility: University of California, San Francisco-Fresno

location_facility: Universitair Medisch Centrum Sint Radboud

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital das Clínicas da Universidade Federal de Minas Gerais

location_facility: The First Affiliated Hospital of Nanjing Medical University

location_facility: Shenyang General Hospital of Shenyang Military Command

location_facility: King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

location_facility: University of Iowa Hospitals and Clinics

location_facility: Escola Paulista de Medicina, Universidade Federal de São Paulo

location_facility: University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute

location_facility: Unidad de Investigacion Clinica en Medicina S.C.

location_facility: Renji Hospital of Shanghai Jiaotong University

location_facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. Fryderyka Chopina

summary: This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.


title: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

acronym: FREEDOM-EV

summary: This is an international, multicenter, randomized, double-blind, placebo-controlled, event driven study in subjects with pulmonary arterial hypertension.

ReferenceCitation: White RJ, Jerjes-Sanchez C, Bohns Meyer GM, Pulido T, Sepulveda P, Wang KY, Grünig E, Hiremath S, Yu Z, Gangcheng Z, Yip WLJ, Zhang S, Khan A, Deng CQ, Grover R, Tapson VF; FREEDOM-EV Investigators. Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension. A Double-Blind Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2020 Mar 15;201(6):707-717. doi: 10.1164/rccm.201908-1640OC.

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Sentara Cardiovascular Research Institute

location_facility: University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program

location_facility: Bergmannsheil Berufsgenossenschaftliche Universitätsklinik GmbH

location_facility: Hospital das Clinicas da Universidade Federal de Goias

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K. Marcinkowskiego w Poznaniu

location_facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu- UNESP

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Centre Hospitalier Universitaire Hopital Nord

location_facility: The Second Affiliated Hospital of Nanchang Medical University

location_facility: University of Florida College of Medicine, Jacksonville

location_facility: Hospital da Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: The University of Texas Health Science Center at Houston

location_facility: General Hospital of Thessaloniki, "G.Papanikolaou"

location_facility: The Chaim Sheba Medical Center at Tel Hashomer

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Complexo Hospitalar Santa Casa de Porto Alegre

location_facility: Shanghai Pulmonary Hospital of Tongji University

location_facility: Perelman Center for Advanced Medicine; University of Pennsylvania

location_facility: University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine

location_facility: University of California, San Francisco-Fresno

location_facility: Universitair Medisch Centrum Sint Radboud


title: A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis

summary: This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

ReferenceCitation: Gao X, Jia G, Guttman A, DePianto DJ, Morshead KB, Sun KH, Ramamoorthi N, Vander Heiden JA, Modrusan Z, Wolters PJ, Jahreis A, Arron JR, Khanna D, Ramalingam TR. Osteopontin Links Myeloid Activation and Disease Progression in Systemic Sclerosis. Cell Rep Med. 2020 Nov 17;1(8):100140. doi: 10.1016/j.xcrm.2020.100140. eCollection 2020 Nov 17.

ReferenceCitation: Stifano G, Sornasse T, Rice LM, Na L, Chen-Harris H, Khanna D, Jahreis A, Zhang Y, Siegel J, Lafyatis R. Skin Gene Expression Is Prognostic for the Trajectory of Skin Disease in Patients With Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol. 2018 Jun;70(6):912-919. doi: 10.1002/art.40455.

ReferenceCitation: Denton CP, Ong VH, Xu S, Chen-Harris H, Modrusan Z, Lafyatis R, Khanna D, Jahreis A, Siegel J, Sornasse T. Therapeutic interleukin-6 blockade reverses transforming growth factor-beta pathway activation in dermal fibroblasts: insights from the faSScinate clinical trial in systemic sclerosis. Ann Rheum Dis. 2018 Sep;77(9):1362-1371. doi: 10.1136/annrheumdis-2018-213031. Epub 2018 May 31.

ReferenceCitation: Khanna D, Denton CP, Lin CJF, van Laar JM, Frech TM, Anderson ME, Baron M, Chung L, Fierlbeck G, Lakshminarayanan S, Allanore Y, Pope JE, Riemekasten G, Steen V, Müller-Ladner U, Spotswood H, Burke L, Siegel J, Jahreis A, Furst DE. Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). Ann Rheum Dis. 2018 Feb;77(2):212-220. doi: 10.1136/annrheumdis-2017-211682. Epub 2017 Oct 24.

ReferenceCitation: Khanna D, Denton CP, Jahreis A, van Laar JM, Frech TM, Anderson ME, Baron M, Chung L, Fierlbeck G, Lakshminarayanan S, Allanore Y, Pope JE, Riemekasten G, Steen V, Müller-Ladner U, Lafyatis R, Stifano G, Spotswood H, Chen-Harris H, Dziadek S, Morimoto A, Sornasse T, Siegel J, Furst DE. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. Lancet. 2016 Jun 25;387(10038):2630-2640. doi: 10.1016/S0140-6736(16)00232-4. Epub 2016 May 5. Erratum in: Lancet. 2018 Apr 7;391(10128):1356.

lead_sponsor: Hoffmann-La Roche

location_country:
United Kingdom
Canada
United States
France
Germany


title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy

summary:
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy.

Patients must undergo molecular pre-screening prior to entry.

ReferenceCitation: Musolino A, Campone M, Neven P, Denduluri N, Barrios CH, Cortes J, Blackwell K, Soliman H, Kahan Z, Bonnefoi H, Squires M, Zhang Y, Deudon S, Shi MM, André F. Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR(+), HER2(-) breast cancer that had progressed during or after prior endocrine therapy. Breast Cancer Res. 2017 Feb 10;19(1):18. doi: 10.1186/s13058-017-0807-8.

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Austria
Russian Federation
Argentina
Hungary
United States
France
Peru
South Africa
Belgium
Netherlands

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC

location_facility: Nebraska Methodist Hospital Estabrook Cancer Center

location_facility: Wenatchee Valley Medical Center Wenatchee Valley

location_facility: University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1

location_facility: Cedars Sinai Medical Center Samuel Oschin Cancer Center

location_facility: Indiana University Health Goshen Center for Cancer SC

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

location_facility: Cancer Centers of the Carolinas Dept. of CC of the Carolinas

location_facility: Virginia Cancer Specialists, PC Dept.ofFairfax SC

location_facility: City of Hope National Medical Center COH 3

location_facility: Saint Barnabas Medical Center CancerCenter of Saint Barnabas

location_facility: Oncology Specialists, SC Lutheran General Advanced Care

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

location_facility: Duke University Medical Center Duke (SC)


title: Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

lead_sponsor: Sanofi

ReferenceCitation: Beaumont H, Evans TL, Klifa C, Guermazi A, Hong SR, Chadjaa M, Monostori Z. Discrepancies of assessments in a RECIST 1.1 phase II clinical trial - association between adjudication rate and variability in images and tumors selection. Cancer Imaging. 2018 Dec 11;18(1):50. doi: 10.1186/s40644-018-0186-0.

ReferenceCitation: Evans TL, Cho BC, Udud K, Fischer JR, Shepherd FA, Martinez P, Ramlau R, Syrigos KN, Shen L, Chadjaa M, Wolf M. Cabazitaxel Versus Topotecan in Patients with Small-Cell Lung Cancer with Progressive Disease During or After First-Line Platinum-Based Chemotherapy. J Thorac Oncol. 2015 Aug;10(8):1221-8. doi: 10.1097/JTO.0000000000000588.

location_country:
Poland
Brazil
Spain
Greece
Italy
Russian Federation
Canada
Ukraine
Hungary
Korea, Republic of
United States
Chile
France
Romania
Norway
Germany

location_facility:
Investigational Site Number 250003
Investigational Site Number 380002
Investigational Site Number 840001
Investigational Site Number 840006
Investigational Site Number 300003
Investigational Site Number 643006
Investigational Site Number 643003
Investigational Site Number 616002
Investigational Site Number 410002
Investigational Site Number 152001
Investigational Site Number 380001
Investigational Site Number 300002
Investigational Site Number 616001
Investigational Site Number 410001
Investigational Site Number 804002
Investigational Site Number 124004
Investigational Site Number 152005
Investigational Site Number 250002
Investigational Site Number 804001
Investigational Site Number 348003
Investigational Site Number 578002
Investigational Site Number 348002
Investigational Site Number 642003
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 616004
Investigational Site Number 642005
Investigational Site Number 840007
Investigational Site Number 616003
Investigational Site Number 642002
Investigational Site Number 643005
Investigational Site Number 724005
Investigational Site Number 578001
Investigational Site Number 724001
Investigational Site Number 380004
Investigational Site Number 276003
Investigational Site Number 643001
Investigational Site Number 578003
Investigational Site Number 300004
Investigational Site Number 124003
Investigational Site Number 124001
Investigational Site Number 300001
Investigational Site Number 124002
Investigational Site Number 276006
Investigational Site Number 348001
Investigational Site Number 410003
Investigational Site Number 250007
Investigational Site Number 300005
Investigational Site Number 724004
Investigational Site Number 840005
Investigational Site Number 804004
Investigational Site Number 840003
Investigational Site Number 642001
Investigational Site Number 250004
Investigational Site Number 348004
Investigational Site Number 076001
Investigational Site Number 250005
Investigational Site Number 380005

summary:
Primary Objective:

To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy.

Secondary Objectives:

To assess disease progression free rate at 12 weeks
To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and duration of response
To assess Overall Survival (OS)
To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC] version 4.03)
To assess the Health-Related Quality of Life (HRQoL)


title: A Multicenter, Single-blind, Randomized Parallel-group Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis Responding Inadequately to Methotrexate

lead_sponsor: UCB Pharma SA

ReferenceCitation: Smolen JS, Burmester GR, Combe B, Curtis JR, Hall S, Haraoui B, van Vollenhoven R, Cioffi C, Ecoffet C, Gervitz L, Ionescu L, Peterson L, Fleischmann R. Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study. Lancet. 2016 Dec 3;388(10061):2763-2774. doi: 10.1016/S0140-6736(16)31651-8. Epub 2016 Nov 15. Erratum in: Lancet. 2017 Feb 4;389(10068):e2.

ReferenceCitation: Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

location_country:
Poland
Portugal
Romania
Spain
Greece
Austria
Australia
Ireland
Canada
Italy
Monaco
Switzerland
United Kingdom
Hungary
United States
France
Mexico
Germany
Bulgaria
Czechia

summary: This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.


title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

acronym: EDITION II

summary:
Primary Objective:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus

Secondary Objective:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia

ReferenceCitation: Yki-Järvinen H, Bergenstal R, Ziemen M, Wardecki M, Muehlen-Bartmer I, Boelle E, Riddle MC; EDITION 2 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014 Dec;37(12):3235-43. doi: 10.2337/dc14-0990. Epub 2014 Sep 5.

ReferenceCitation: Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.

ReferenceCitation: Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.

ReferenceCitation: Bonadonna RC, Renard E, Cheng A, Fritsche A, Cali A, Melas-Melt L, Umpierrez GE. Switching to insulin glargine 300 U/mL: Is duration of prior basal insulin therapy important? Diabetes Res Clin Pract. 2018 Aug;142:19-25. doi: 10.1016/j.diabres.2018.03.041. Epub 2018 Apr 9.

ReferenceCitation: Yale JF, Pettus JH, Brito-Sanfiel M, Lavalle-Gonzalez F, Merino-Trigo A, Stella P, Chevalier S, Buzzetti R. The effect of concomitant DPPIVi use on glycaemic control and hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus insulin glargine 100 U/mL (Gla-100) in people with type 2 diabetes: A patient-level meta-analysis of EDITION 2 and 3. PLoS One. 2018 Jan 25;13(1):e0190579. doi: 10.1371/journal.pone.0190579. eCollection 2018.

ReferenceCitation: Yki-Järvinen H, Bergenstal RM, Bolli GB, Ziemen M, Wardecki M, Muehlen-Bartmer I, Maroccia M, Riddle MC. Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension. Diabetes Obes Metab. 2015 Dec;17(12):1142-9. doi: 10.1111/dom.12532. Epub 2015 Sep 14.

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

location_country:
Portugal
Romania
Spain
Russian Federation
Finland
Canada
Hungary
United States
Chile
France
South Africa
Mexico
Germany

location_facility:
Investigational Site Number 840027
Investigational Site Number 276009
Investigational Site Number 643006
Investigational Site Number 840114
Investigational Site Number 840022
Investigational Site Number 840012
Investigational Site Number 840130
Investigational Site Number 840028
Investigational Site Number 152012
Investigational Site Number 840110
Investigational Site Number 840040
Investigational Site Number 840513
Investigational Site Number 840510
Investigational Site Number 152005
Investigational Site Number 710007
Investigational Site Number 840094
Investigational Site Number 643010
Investigational Site Number 840091
Investigational Site Number 840098
Investigational Site Number 840128
Investigational Site Number 152010
Investigational Site Number 643007
Investigational Site Number 642003
Investigational Site Number 840523
Investigational Site Number 840085
Investigational Site Number 643016
Investigational Site Number 724005
Investigational Site Number 124013
Investigational Site Number 840024
Investigational Site Number 840162
Investigational Site Number 710010
Investigational Site Number 840503
Investigational Site Number 620004
Investigational Site Number 840199
Investigational Site Number 724003
Investigational Site Number 840077
Investigational Site Number 840018
Investigational Site Number 840514
Investigational Site Number 643009
Investigational Site Number 840141
Investigational Site Number 840045
Investigational Site Number 840526
Investigational Site Number 840158
Investigational Site Number 724004
Investigational Site Number 642001
Investigational Site Number 124024
Investigational Site Number 250004
Investigational Site Number 840066
Investigational Site Number 124011
Investigational Site Number 840076
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 484008
Investigational Site Number 643014
Investigational Site Number 124022
Investigational Site Number 840153
Investigational Site Number 840113
Investigational Site Number 840080
Investigational Site Number 250003
Investigational Site Number 643002
Investigational Site Number 484007
Investigational Site Number 840104
Investigational Site Number 840084
Investigational Site Number 642011
Investigational Site Number 710008
Investigational Site Number 642009
Investigational Site Number 484003
Investigational Site Number 348009
Investigational Site Number 124019
Investigational Site Number 840004
Investigational Site Number 348003
Investigational Site Number 710012
Investigational Site Number 276007
Investigational Site Number 642004
Investigational Site Number 840025
Investigational Site Number 840527
Investigational Site Number 840519
Investigational Site Number 276005
Investigational Site Number 840064
Investigational Site Number 840033
Investigational Site Number 246001
Investigational Site Number 643013
Investigational Site Number 840150
Investigational Site Number 840093
Investigational Site Number 840528
Investigational Site Number 840032
Investigational Site Number 276003
Investigational Site Number 642014
Investigational Site Number 710006
Investigational Site Number 840122
Investigational Site Number 348010
Investigational Site Number 348008
Investigational Site Number 484001
Investigational Site Number 642013
Investigational Site Number 840026
Investigational Site Number 124002
Investigational Site Number 484006
Investigational Site Number 642015
Investigational Site Number 642010
Investigational Site Number 840003
Investigational Site Number 840014
Investigational Site Number 840078
Investigational Site Number 152003
Investigational Site Number 840041
Investigational Site Number 840037
Investigational Site Number 840047
Investigational Site Number 840142
Investigational Site Number 840001
Investigational Site Number 840048
Investigational Site Number 643011
Investigational Site Number 840159
Investigational Site Number 840148
Investigational Site Number 840020
Investigational Site Number 840088
Investigational Site Number 840504
Investigational Site Number 152001
Investigational Site Number 276008
Investigational Site Number 840031
Investigational Site Number 840107
Investigational Site Number 152014
Investigational Site Number 484004
Investigational Site Number 276004
Investigational Site Number 484010
Investigational Site Number 348005
Investigational Site Number 642007
Investigational Site Number 484009
Investigational Site Number 840087
Investigational Site Number 840060
Investigational Site Number 840042
Investigational Site Number 840038
Investigational Site Number 840139
Investigational Site Number 840007
Investigational Site Number 642005
Investigational Site Number 642002
Investigational Site Number 840011
Investigational Site Number 710005
Investigational Site Number 840097
Investigational Site Number 840140
Investigational Site Number 840072
Investigational Site Number 840068
Investigational Site Number 124018
Investigational Site Number 724006
Investigational Site Number 840509
Investigational Site Number 840517
Investigational Site Number 840090
Investigational Site Number 620007
Investigational Site Number 840089
Investigational Site Number 124025
Investigational Site Number 642006
Investigational Site Number 710014
Investigational Site Number 152009
Investigational Site Number 840063
Investigational Site Number 840015
Investigational Site Number 840065
Investigational Site Number 152006
Investigational Site Number 710003
Investigational Site Number 840134
Investigational Site Number 840160
Investigational Site Number 840069
Investigational Site Number 250009
Investigational Site Number 643008
Investigational Site Number 840056
Investigational Site Number 124014
Investigational Site Number 152002
Investigational Site Number 124016
Investigational Site Number 840019
Investigational Site Number 152004
Investigational Site Number 710001
Investigational Site Number 840008
Investigational Site Number 840145
Investigational Site Number 124020
Investigational Site Number 642008
Investigational Site Number 840525
Investigational Site Number 840124
Investigational Site Number 840502
Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 840021
Investigational Site Number 840034
Investigational Site Number 152007
Investigational Site Number 840161
Investigational Site Number 348002
Investigational Site Number 152013
Investigational Site Number 724002
Investigational Site Number 840057
Investigational Site Number 840009
Investigational Site Number 840023
Investigational Site Number 348007
Investigational Site Number 643005
Investigational Site Number 840081
Investigational Site Number 840135
Investigational Site Number 840074
Investigational Site Number 348006
Investigational Site Number 642012
Investigational Site Number 840115
Investigational Site Number 724001
Investigational Site Number 840149
Investigational Site Number 840520
Investigational Site Number 643001
Investigational Site Number 840050
Investigational Site Number 710002
Investigational Site Number 643004
Investigational Site Number 840049
Investigational Site Number 840079
Investigational Site Number 840099
Investigational Site Number 348001
Investigational Site Number 840108
Investigational Site Number 840005
Investigational Site Number 124026
Investigational Site Number 840518
Investigational Site Number 348004
Investigational Site Number 124010
Investigational Site Number 840095


title: A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer

summary: This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.

location_country:
Brazil
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United Kingdom
Ukraine
Hungary
United States
Chile
France
Israel
Germany

location_facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Florida Cancer Specialists - Fort Myers (Colonial Center Dr)

location_facility: Flinders Medical Centre; Medical Oncology

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Hematology Oncology PC; Bennett Cancer Center

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: City Oncology Hospital; Chemotherapy Dept

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

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

location_facility: Centre Hospitalier de Villefranche sur Saone

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Isis Centro Especializado de Luces; Oncology

location_facility: Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie

location_facility: Vas Megyei Markusovszky Korhaz ; Pulmonology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

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

location_facility: Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University

location_facility: St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie

location_facility: A.O.U.I. VERONA-OSPEDALE POLICLINICO G.B. ROSSI BORGO ROMA;ONCOLOGIA MEDICA-d.U.

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Royal Prince Alfred Hospital; Sydney Cancer Centre

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: Wayne State University; Hemat/Onc, 4HW CRC

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezet

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Catharina-ziekenhuis; Longgeneeskunde en Tuberculose

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Zala Megyei Korhaz; Dept of Pulmonary Medicine

location_facility: Clinique Catherine de Sienne; Service de cancérologie

location_facility: Royal Surrey County Hospital; St. Lukes Cancer Centre

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Crimean Republican Institute; Oncology Clin Dispensary; Chemotherapy Dept

location_facility: Rsrch Onc Inst of Rosmed Tech; n.a. prof. N.N. Petrov; Dept of Surgery

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Sumy Reg. Clin. Oncological Dispensary; Thoracall Department

location_facility: Hospital Nuestra Señora de Sonsoles; servicio de Oncologia

location_facility: Peachtree Hematology & Oncology Consultants, Pc

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Clinica de Tratamento e Pesquisa Oncologica - Oncotek

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Krankenhaus Grosshansdorf;Pneumologie & Thoraxchirurgie


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

acronym: BLISS-SC

summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

ReferenceCitation: Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3). pii: e001747. doi: 10.1136/rmdopen-2021-001747.

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: Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1). pii: e000459. doi: 10.1136/lupus-2020-000459.

ReferenceCitation: Lokhandwala T, Yue B, Coutinho AD, Bell CF. Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus. Lupus Sci Med. 2021 Feb;8(1):e000438. doi: 10.1136/lupus-2020-000438.

ReferenceCitation: Doria A, Bass D, Schwarting A, Hammer A, Gordon D, Scheinberg M, Fox NL, Groark J, Stohl W, Kleoudis C, Roth D. A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus. Lupus. 2018 Aug;27(9):1489-1498. doi: 10.1177/0961203318777634. Epub 2018 May 28.

ReferenceCitation: Doria A, Stohl W, Schwarting A, Okada M, Scheinberg M, van Vollenhoven R, Hammer AE, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Anti-Double-Stranded DNA-Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2018 Aug;70(8):1256-1264. doi: 10.1002/art.40511. Epub 2018 Jun 15.

ReferenceCitation: Stohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, Kleoudis C, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017 May;69(5):1016-1027. doi: 10.1002/art.40049. Epub 2017 Apr 7.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
Japan
Romania
Czechia
Poland
Portugal
Austria
Russian Federation
Argentina
Mexico
Malaysia
Singapore
Sweden
Brazil
Hungary
Germany
Bulgaria
Denmark
Taiwan
Thailand
France
Chile
Colombia


type: Registry Identifier

title: A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

summary: This is a phase 3, randomized, 2-arm, open-label, international trial evaluating alisertib compared with single-agent treatment, as selected by the investigator from the offered options of pralatrexate or gemcitabine or romidepsin, in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL). Note: romidepsin was not used as a single-agent comparator outside the United States of America (USA) as supply was not available.

ReferenceCitation: O'Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized Phase III Study of Alisertib or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. doi: 10.1200/JCO.18.00899. Epub 2019 Feb 1.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Mexico
Sweden
Slovakia
Egypt
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Belarus
New Zealand
France
Chile
Netherlands


title: Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis

summary:
Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy.

Disease activity will be monitored systematically every 3 months by the Disease Activity Score.

Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies.

Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum.

Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).

Patients will be followed for 2 years.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Sepriano A, Ramiro S, FitzGerald O, Østergaard M, Homik J, van der Heijde D, Elkayam O, Thorne JC, Larché MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Landewé R, Maksymowych WP. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort. J Rheumatol. 2020 Jun 1;47(6):809-819. doi: 10.3899/jrheum.190303. Epub 2019 Sep 15.

ReferenceCitation: Maksymowych WP, FitzGerald O, Østergaard M, Homik J, van der Heijde D, Lambert RG, Elkayam O, Ramiro S, Thorne JC, Larché MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Sepriano A, Landewé R. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA. J Rheumatol. 2020 Jun 1;47(6):796-808. doi: 10.3899/jrheum.190302. Epub 2019 Sep 1.

lead_sponsor: Canadian Research & Education in Arthritis

location_country:
Denmark
Ireland
Italy
Netherlands
Canada
United States
France
Israel
Norway
Germany

location_facility: Department of Rheumatology, Diakonhjemmet Hospital

location_facility: Arthritis Center, University of Manitoba

location_facility: Le Roux Liana, Centre d'Investigation Clinique

location_facility: Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen

location_facility: Afdeling Reumatologie, Leids Universitair Medisch Centrum

location_facility: Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie

location_facility: Service de Rheumatologie-CHU Bordeaux Pellegrin

location_facility: Department of Rheumatology, University of Verona

location_facility: Division of Allergy, Immunology and Rheumatology, University of Rochester

location_facility: Rheumatologist Hospital for Special Surgery

location_facility: Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan

location_facility: Division of Rheumatology, Columbia University, College of Physicians and Surgeons

location_facility: Johns Hopkins Arthritis Center, Johns Hopkins University

location_facility: Department of Rheumatology, Copenhagen University Hospital at Glostrup

location_facility: Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology

location_facility: Departement de rheumatologie, Hopital Lapeyronie

location_facility: Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie

location_facility: Department of Rheumatology, St. Vincents University Hospital

location_facility: Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie

location_facility: Division of Rheumatology, University of Alberta Hospital

intervention_type: Other


title: A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease

summary: The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.

ReferenceCitation: Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A. Eldelumab [anti-interferon-γ-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study. J Crohns Colitis. 2017 Jul 1;11(7):811-819. doi: 10.1093/ecco-jcc/jjx005.

ReferenceCitation: Khanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG. Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease. Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Hungary
Puerto Rico
United States
France
Israel
South Africa
Belgium

location_facility: Southern California Medical Gastroenterology Group

location_facility: Gastroenterology Research Of San Antonio

location_facility: Nyu Langone Long Island Clinical Research Associates

location_facility: University Of Puerto Rico School Of Medicine

location_facility: Gastroenterology Research Of New Orleans

location_facility: Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr

location_facility: University Of North Carolina At Chapel Hill