filgotinib clinical trials

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at … M.F. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department, Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council, Cambridge University Hospital NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Glasgow Clinical Research Facility - Queen Elizabeth University Hospital, Imperial College Healthcare NHS Trust, St Mary's Hospital, Norfolk and Norwich University Hospital NHS Foundation Trust, Oxford University Hospitals NHS Foundation Trust, St Helens and Knowsley Teaching Hospitals NHS Trust, Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility. de C.V. Bay of Plenty District Health Board - Tauranga Hospital, Vestre Viken Hospital Trust, Baerum Hospital, Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych, Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS. Government Medical College & Sassoon General Hospital, Grant Medical Foundation Ruby Hall Clinic, Institute of Gastroenterology & Liver Disease. Nizhniy Novgorod, Russian Federation, 603126, State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12", State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital", Saint Petersburg, Russian Federation, 193163, Saint Petersburg, Russian Federation, 197110, Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38", Saint-Petersburg, Russian Federation, 191015, "Scientific Research Centre ECO-safety" LLC, Saint-Petersburg, Russian Federation, 196143, State Healthcare Institution "Regional Clinical Hospital", Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC, State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center", KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra, Hospital Universitario Central de Asturias, Gastroenterologische Praxis Balsiger, Seibold und Partner, Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch, Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department, Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Gilead has paused enrollment in clinical trials of filgotinib in three indications pending feedback from the FDA. The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine", Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1, Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus", Kyiv City Clinical Hospital No. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration). Marii Sklodowskiej-Curie, Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie, Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz. Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58. MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. N.A. For general information, Learn About Clinical Studies. 2021 Mar 19;1-26. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The companies have multiple clinical study programs for filgotinib in inflammatory diseases, including the FINCH Phase 3 program in rheumatoid arthritis, the Phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies in uveitis and in small bowel and fistulizing Crohn’s disease. Talk with your doctor and family members or friends about deciding to join a study. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914522. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Trial summary. Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc. Information provided by (Responsible Party): Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks. NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply. k. Gabinet Lekarski Dr. Hab. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 [ Time Frame: Week 10 ], Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 [ Time Frame: Week 58 ], Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10 [ Time Frame: Week 10 ], Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10 [ Time Frame: Week 10 ], Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10 [ Time Frame: Week 10 ], Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10 [ Time Frame: Week 10 ], Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845 [ Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 ], Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845 [ Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 ], Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984 [ Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 ], Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984 [ Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 ], Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984 [ Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 ], Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58 [ Time Frame: Week 58 ], Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845 [ Time Frame: Week 26 (any Time) and Week 58 (predose) ], Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Ulcerative Colitis (UC) In May 2020, Gilead and Galapagos announced positive topline results with filgotinib in the Phase 3 SELECTION trial in UC. Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Belgyogyaszat - 2. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Vladimirskiy". Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie, Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz, Santa Familia, Centrum Badan, Profilaktyki i Leczenia. Lakeshore Hospital and Research Centre Ltd. Amrita Institute of Medical Sciences and Research Centre, Lokmanya Tilak Municipal General Hospital, Department of Surgery, B.J. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Previous clinical trials for filgotinib for RA Phase 2a proof-of-concept trial In November 2011, Galapagos announced topline data from a Phase 2a proof-of-concept trial (GLPG0634-CL-201), a four-week trial performed in RA patients with insufficient response to MTX. For general information, Learn About Clinical Studies. September 2020: Filgotinib was approved for medical use in both the European Union and Japan. Online ahead of print. S.R.KallaMemorial Gastro.&General Hospital, Lokmanya Tilak Municipal General Hospital, Grant Medical Foundation Ruby Hall Clinic, Institute of Gastroenterology & Liver Disease, Sunshine Hospitals, Ospedale Clinicizzato SS. Gilead Sciences and Galapagos have released 52-week clinical trial data showing the durability of filgotinib in rheumatoid arthritis patients. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. You have reached the maximum number of saved studies (100). Listing a study does not mean it has been evaluated by the U.S. Federal Government. Danylo Halytsky Lviv National Medical, State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine", Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. … Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. State Higher Education Institution Ivano-Frankivsk National, Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department, Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1, Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus", Kyiv City Clinical Hospital No. Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58. Gilead Sciences has suspended enrollment in two Phase 3 trials studying the effects of filgotinib, an anti-inflammatory therapy currently being investigated in several inflammatory conditions, in patients with ankylosing spondylitis (AS). Annunziata - Dipartimento di Medicina, Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico, Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello, UOC Gastroenterologia ed Endoscopia Digestiva, Medical Hospital, Tokyo Medical and Dental University, Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital, Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center, University Hospital, Kyoto Prefectural University of Medicine, Kitasato University Kitasato Institute Hospital, Hyogo College of Medicine College Hospital, Kitasato University Hospital, THE KITASATO INSTITUTE, National Hospital Organization Sendai Medical Center, National Hospital Organization Takasaki General Medical Center, Yokohama Health Medicine Association Kannai Suzuki Clinic, Shiga University of Medical Science Hospital, The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of, 16247, Yonsei University Health System, Severance Hospital, Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Yonsei University Wonju Severance Christian Hospital, University Kebangsaan Malaysia Medical Centre. k. Gabinet Lekarski Dr. Hab. Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. Hospital da Senhora da Oliveira Guimaraes, E.P.E. The week 52 data from the trials was consistent with and supported filgotinib’s efficacy, safety and tolerability profiles reported at weeks 12 and 24. Danylo Halytsky Lviv National Medical, Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department, State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine", Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. Vladimirskiy". First Department of Internal Medicine, School of Medicine, University of Occupational and … j. Specjalistyczne Centrum Gastrologii i Endoskopii. A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease: Actual Study Start Date : July 11, 2017: Actual Primary Completion Date : July 31, 2020: Estimated Study Completion Date : October 2024 Note: Other protocol defined Inclusion/Exclusion criteria may apply. Trial summary. Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58). Gasztroenterologia, Debreceni Egyetem Klinikai Kozpont, II. Why Should I Register and Submit Results? Clinical Trials Nct Page Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis Choosing to participate in a study is an important personal decision. Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. We sought to gain insight into the mode of action and immunological effects of filgotinib, a JAK1 selective inhibitor, in active RA by analyzing secreted and cell-based biomarkers key to RA pathophysiology in two phase 2b trials of filgotinib in active RA. Annunziata - Dipartimento di Medicina, Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello, UOC di Gastroenterologia ed Endoscopia Digestiva, UOC Gastroenterologia ed Endoscopia Digestiva, Ohmori Toshihide gastro-intestinal Clinic, Medical Hospital, Tokyo Medical and Dental University, Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital, Medical Corporation Ryowakai, Hamamatsu South Hospital, Saitama Medical Center, Saitama Medical University, Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center, University Hospital, Kyoto Prefectural University of Medicine, Kitasato University Kitasato Institute Hospital, Hyogo College of Medicine College Hospital, Shiga University of Medical Science Hospital, Kitasato University Hospital, THE KITASATO INSTITUTE, National Hospital Organization Sendai Medical Center, National Hospital Organization Takasaki General Medical Center, Yokohama Health Medicine Association Kannai Suzuki Clinic, Guri-Si, Gyeonggi-Do, Korea, Republic of, 471-701, The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of, 16247, CHA Bundang Medical Center, CHA University, Yonsei University Health System, Severance Hospital, Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Yonsei University Wonju Severance Christian Hospital, Universiti Kebangsaan Malaysia Medical Center. 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