50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue). Ulcerative Colitis (UC) In May 2020, Gilead and Galapagos announced positive topline results with filgotinib in the Phase 3 SELECTION trial in UC. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. 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. Lakeshore Hospital and Research Centre Ltd. Amrita Institute of Medical Sciences and Research Centre, Lokmanya Tilak Municipal General Hospital, Department of Surgery, B.J. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914522. You have reached the maximum number of saved studies (100). The efficacy of filgotinib is being studied in a Phase IIb program (DARWIN trial 1, 2) with involvement of 886 rheumatoid arthritis patients and 180 Crohn's disease patients. Following this, Gilead filed a request for marketing authorization with the EMA for the approval of filgotinib in UC in … 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. The SELECTION trial is one of multiple clinical studies of filgotinib in a range of inflammatory conditions, including the FINCH Phase 3 program in rheumatoid arthritis, 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial Ann Rheum Dis. 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. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. Research Clinical trials. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Mod Rheumatol. A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy: Actual Study Start Date : August 8, 2016 k. Gabinet Lekarski Dr. Hab. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Sunshine Hospitals, Clinical Research Centre, Mater Misericordiae University Hospital, Wellcome Trust HRB Clinical Research Facility, Ospedale Clinicizzato SS. and Research Unit, Hepatogastroenterology Unit, University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division, University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division, General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. 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. Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon, Active tuberculosis (TB) or history of latent TB that has not been treated, Use of any prohibited concomitant medications as described in the study protocol. Objectives To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The … Study record managers: refer to the Data Element Definitions if submitting registration or results information. Centro Hospitalar e Universitario de Coimbra, E.P.E. N. Med. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS, Uniwersyteckie Centrum Kliniczne im. Why Should I Register and Submit Results? doi: 10.1136/annrheumdis-2020-219214. 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. A phase 2b/3 trial of Gilead Sciences and Galapagos’ filgotinib in ulcerative colitis patients has met its primary endpoint. For general information, Learn About Clinical Studies. Toronto Digestive Disease Associates Inc. Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni, Thomayerova nemocnice, Interni klinika 3. Please remove one or more studies before adding more. Marii Sklodowskiej-Curie, Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie, Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz. Choosing to participate in a study is an important personal decision. Belgyogyaszat - 2. H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.  (Clinical Trial), 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, Experimental: Induction Study (Cohort A): Filgotinib 200 mg, Experimental: Induction Study (Cohort A): Filgotinib 100 mg, Placebo Comparator: Induction Study (Cohort A): Placebo, Experimental: Induction Study (Cohort B): Filgotinib 200 mg, Experimental: Induction Study (Cohort B): Filgotinib 100 mg, Placebo Comparator: Induction Study (Cohort B): Placebo, Experimental: Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 200 mg, Experimental: Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 100 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Placebo, 18 Years to 75 Years   (Adult, Older Adult), Digestive Health Specialists of the Southeast, Scottsdale, Arizona, United States, 85259, Long Beach, California, United States, 90822, Los Angeles, California, United States, 90048, Lone Tree, Colorado, United States, 80124, Farmington, Connecticut, United States, 06032, Gainesville, Florida, United States, 32610, Lakewood Ranch, Florida, United States, 34211, University of Miami Crohn's and Colitis Center, Port Orange, Florida, United States, 32127, Winter Park, Florida, United States, 32789, Zephyrhills, Florida, United States, 33540, Gastroenterology Associates of Central Georgia, LLC, University of Louisville, Clinical Trials Unit, Louisville, Kentucky, United States, 40202, Shreveport, Louisiana, United States, 71105, Annapolis, Maryland, United States, 21401, MGG Group Co., Inc., Chevy Chase Clinical Research, Chevy Chase, Maryland, United States, 20815, Hagerstown, Maryland, United States, 21742, Massachusetts General Hospital - Crohn's and Colitis Center, Boston, Massachusetts, United States, 02114, Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan, United States, 48047, Rochester, Minnesota, United States, 55905, Kansas City, Missouri, United States, 64131, Saint Louis, Missouri, United States, 63110, NYU Langone Long Island Clinical Research Associates, Great Neck, New York, United States, 11021, Raleigh, North Carolina, United States, 27607, Fargo Gastroenterology and Hepatology Clinic, Fargo, North Dakota, United States, 58103, Great Lakes Gastroenterology Research, LLC, Gastroenterology Associates of Orangeburg, Orangeburg, South Carolina, United States, 29118, Rapid City, South Dakota, United States, 57701, Chattanooga, Tennessee, United States, 37421, Germantown, Tennessee, United States, 38138, Nashville, Tennessee, United States, 37211, Vanderbilt University Medical Center - IBD Clinic, Nashville, Tennessee, United States, 37212-1375, Fort Sam Houston, Texas, United States, 78219, Baylor College of Medicine- Baylor Medical Center, The University of Texas Health Science Center at Houston, Clinical Associates in Research Therapeutics of America, LLC, The Woodlands, Texas, United States, 77380, Charlottesville, Virginia, United States, 22908, Chesapeake, Virginia, United States, 23320, Lansdowne Town Center, Virginia, United States, 20176, University of Wisconsin Hospital & Clinics, Wauwatosa, Wisconsin, United States, 53225, Instituto de Investigaciones Clinicas Mar del Plata, Darlinghurst, New South Wales, Australia, 2010, Kingswood, New South Wales, Australia, 2747, Mountain Creek, Queensland, Australia, 4557, South Brisbane, Queensland, Australia, 4101, Woolloongabba, Queensland, Australia, 4102, Woodville South, South Australia, Australia, 5011, Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph, University of Calgary, Heritage Medical Research Clinic, The Gordon and Leslie Diamond Health Care Centre, Vancouver, British Columbia, Canada, V5Z 1M9, Hamilton Health Sciences Corporation, McMaster University Medical Centre. Habitat Management Jobs, Custom Windows 10, Shamrock Shuffle Manchester, Nh, Ucla Font Generator, Brown And White Dog Names Male, Kenapa Instagram Error, Hund Kaufen Schweiz Tierheim, Oil To Gas Conversion Calculator, Bolton Wanderers Staff, Ucla Anderson Experiential Learning, Wex Stock Forecast, " /> 50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue). Ulcerative Colitis (UC) In May 2020, Gilead and Galapagos announced positive topline results with filgotinib in the Phase 3 SELECTION trial in UC. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. 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. Lakeshore Hospital and Research Centre Ltd. Amrita Institute of Medical Sciences and Research Centre, Lokmanya Tilak Municipal General Hospital, Department of Surgery, B.J. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914522. You have reached the maximum number of saved studies (100). The efficacy of filgotinib is being studied in a Phase IIb program (DARWIN trial 1, 2) with involvement of 886 rheumatoid arthritis patients and 180 Crohn's disease patients. Following this, Gilead filed a request for marketing authorization with the EMA for the approval of filgotinib in UC in … 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. The SELECTION trial is one of multiple clinical studies of filgotinib in a range of inflammatory conditions, including the FINCH Phase 3 program in rheumatoid arthritis, 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial Ann Rheum Dis. 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. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. Research Clinical trials. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Mod Rheumatol. A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy: Actual Study Start Date : August 8, 2016 k. Gabinet Lekarski Dr. Hab. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Sunshine Hospitals, Clinical Research Centre, Mater Misericordiae University Hospital, Wellcome Trust HRB Clinical Research Facility, Ospedale Clinicizzato SS. and Research Unit, Hepatogastroenterology Unit, University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division, University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division, General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. 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. Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon, Active tuberculosis (TB) or history of latent TB that has not been treated, Use of any prohibited concomitant medications as described in the study protocol. Objectives To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The … Study record managers: refer to the Data Element Definitions if submitting registration or results information. Centro Hospitalar e Universitario de Coimbra, E.P.E. N. Med. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS, Uniwersyteckie Centrum Kliniczne im. Why Should I Register and Submit Results? doi: 10.1136/annrheumdis-2020-219214. 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. A phase 2b/3 trial of Gilead Sciences and Galapagos’ filgotinib in ulcerative colitis patients has met its primary endpoint. For general information, Learn About Clinical Studies. Toronto Digestive Disease Associates Inc. Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni, Thomayerova nemocnice, Interni klinika 3. Please remove one or more studies before adding more. Marii Sklodowskiej-Curie, Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie, Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz. Choosing to participate in a study is an important personal decision. Belgyogyaszat - 2. H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.  (Clinical Trial), 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, Experimental: Induction Study (Cohort A): Filgotinib 200 mg, Experimental: Induction Study (Cohort A): Filgotinib 100 mg, Placebo Comparator: Induction Study (Cohort A): Placebo, Experimental: Induction Study (Cohort B): Filgotinib 200 mg, Experimental: Induction Study (Cohort B): Filgotinib 100 mg, Placebo Comparator: Induction Study (Cohort B): Placebo, Experimental: Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 200 mg, Experimental: Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 100 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Placebo, 18 Years to 75 Years   (Adult, Older Adult), Digestive Health Specialists of the Southeast, Scottsdale, Arizona, United States, 85259, Long Beach, California, United States, 90822, Los Angeles, California, United States, 90048, Lone Tree, Colorado, United States, 80124, Farmington, Connecticut, United States, 06032, Gainesville, Florida, United States, 32610, Lakewood Ranch, Florida, United States, 34211, University of Miami Crohn's and Colitis Center, Port Orange, Florida, United States, 32127, Winter Park, Florida, United States, 32789, Zephyrhills, Florida, United States, 33540, Gastroenterology Associates of Central Georgia, LLC, University of Louisville, Clinical Trials Unit, Louisville, Kentucky, United States, 40202, Shreveport, Louisiana, United States, 71105, Annapolis, Maryland, United States, 21401, MGG Group Co., Inc., Chevy Chase Clinical Research, Chevy Chase, Maryland, United States, 20815, Hagerstown, Maryland, United States, 21742, Massachusetts General Hospital - Crohn's and Colitis Center, Boston, Massachusetts, United States, 02114, Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan, United States, 48047, Rochester, Minnesota, United States, 55905, Kansas City, Missouri, United States, 64131, Saint Louis, Missouri, United States, 63110, NYU Langone Long Island Clinical Research Associates, Great Neck, New York, United States, 11021, Raleigh, North Carolina, United States, 27607, Fargo Gastroenterology and Hepatology Clinic, Fargo, North Dakota, United States, 58103, Great Lakes Gastroenterology Research, LLC, Gastroenterology Associates of Orangeburg, Orangeburg, South Carolina, United States, 29118, Rapid City, South Dakota, United States, 57701, Chattanooga, Tennessee, United States, 37421, Germantown, Tennessee, United States, 38138, Nashville, Tennessee, United States, 37211, Vanderbilt University Medical Center - IBD Clinic, Nashville, Tennessee, United States, 37212-1375, Fort Sam Houston, Texas, United States, 78219, Baylor College of Medicine- Baylor Medical Center, The University of Texas Health Science Center at Houston, Clinical Associates in Research Therapeutics of America, LLC, The Woodlands, Texas, United States, 77380, Charlottesville, Virginia, United States, 22908, Chesapeake, Virginia, United States, 23320, Lansdowne Town Center, Virginia, United States, 20176, University of Wisconsin Hospital & Clinics, Wauwatosa, Wisconsin, United States, 53225, Instituto de Investigaciones Clinicas Mar del Plata, Darlinghurst, New South Wales, Australia, 2010, Kingswood, New South Wales, Australia, 2747, Mountain Creek, Queensland, Australia, 4557, South Brisbane, Queensland, Australia, 4101, Woolloongabba, Queensland, Australia, 4102, Woodville South, South Australia, Australia, 5011, Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph, University of Calgary, Heritage Medical Research Clinic, The Gordon and Leslie Diamond Health Care Centre, Vancouver, British Columbia, Canada, V5Z 1M9, Hamilton Health Sciences Corporation, McMaster University Medical Centre. Habitat Management Jobs, Custom Windows 10, Shamrock Shuffle Manchester, Nh, Ucla Font Generator, Brown And White Dog Names Male, Kenapa Instagram Error, Hund Kaufen Schweiz Tierheim, Oil To Gas Conversion Calculator, Bolton Wanderers Staff, Ucla Anderson Experiential Learning, Wex Stock Forecast, " />

filgotinib clinical trials

Filgotinib, a Novel JAK1-Preferential Inhibitor for the Treatment of Rheumatoid Arthritis: An Overview from Clinical Trials. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Talk with your doctor and family members or friends about deciding to join a study. Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie, Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz, Santa Familia, Centrum Badan, Profilaktyki i Leczenia. Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58. Read our, ClinicalTrials.gov Identifier: NCT02914522, Interventional EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. sz. Unidade Local de Saude do Alto Minho, EPE, S.C. Centrul Medical Sana S.R.L., Gastroenterologie, Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II, Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie, Delta Health Care/ Ponderas Academic Hospital, Spitalul Clinic Colentina, Gastroenterologie, Cabinet Particular Policlinic Algomed SRL, Centrul Medical Tuculanu, Gastroenterologie, S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie, State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital", State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital, State Autonomous Institution of Health "Republican Clinical Hospital" of Ministry of Health of the Tatarstan Republic, Federal State Budgetary Healthcare Institution Central Clinical Hospital of the Russian Academy of Sciences, State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow", State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. 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. 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. 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. N. Med. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Induction Study: Proportion of Participants Achieving Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 [ Time Frame: Week 10 ], Induction Study: Proportion of Participants Achieving Endoscopic Response at Week 10 [ Time Frame: Week 10 ], Maintenance Study: Proportion of Participants Achieving Clinical Remission by CDAI at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Proportion of Participants Achieving Endoscopic Response at Week 58 [ Time Frame: Week 58 ], Induction Study: Proportion of Participants Achieving Clinical Remission by Patient Reported Outcomes (PRO2) at Week 10 [ Time Frame: Week 10 ], Induction Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 10 [ Time Frame: Week 10 ], Induction Study: Pharmacokinetic Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ], Maintenance Study: Proportion of Participants Achieving Clinical Remission by PRO2 at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Proportion of Participants Achieving Clinical Response by CDAI at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by CDAI [ Time Frame: Week 58 ], Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by CDAI at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Proportion of Participants Achieving Sustained Clinical Remission by PRO2 [ Time Frame: Week 58 ], Maintenance Study: Proportion of Participants Achieving 6 Month Corticosteroid-Free Remission by PRO2 at Week 58 [ Time Frame: Week 58 ], Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) 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, Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment, Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators, Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab, Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): TNFa antagonists, vedolizumab, and ustekinumab.  (Clinical Trial), Combined Phase 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 Crohn's Disease, Experimental: Filgotinib 200 mg (Induction Study), Experimental: Filgotinib 100 mg (Induction Study), Placebo Comparator: Placebo (Induction Study), 18 Years to 75 Years   (Adult, Older Adult), Contact: Gilead Clinical Study Information Center, Digestive Health Specialists of the Southeast, Scottsdale, Arizona, United States, 85259, Garden Grove, California, United States, 92845, La Jolla, California, United States, 92037, Long Beach, California, United States, 90822, Los Angeles, California, United States, 90048, San Diego, California, United States, 92134, San Francisco, California, United States, 94118, Santa Clarita, California, United States, 91351, University of Colorado Denver and Hospital, Lone Tree, Colorado, United States, 80124, Farmington, Connecticut, United States, 06032, Medstar Georgetown University Hospital (Patient Exams), Washington, District of Columbia, United States, 20007, Coral Springs, Florida, United States, 33067, Gainesville, Florida, United States, 32610, Lakewood Ranch, Florida, United States, 34211. Belgyogyaszati Klinika, Gasztroenterologia, Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia, Gastroplus Digestive Disease Centre Pvt Ltd, Victoria Hospital, Bangalore Medical College and Research Institute, VGM Hospital Institute of Gastroenterology, Asian Institute of Gastroenterology Pvt Ltd, S.R.Kalla Memorial Gastro.&General Hospital. 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. Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo, Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly, Debreceni Egyetem Klinikai Kozpont, II. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue). Ulcerative Colitis (UC) In May 2020, Gilead and Galapagos announced positive topline results with filgotinib in the Phase 3 SELECTION trial in UC. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. 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. Lakeshore Hospital and Research Centre Ltd. Amrita Institute of Medical Sciences and Research Centre, Lokmanya Tilak Municipal General Hospital, Department of Surgery, B.J. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914522. You have reached the maximum number of saved studies (100). The efficacy of filgotinib is being studied in a Phase IIb program (DARWIN trial 1, 2) with involvement of 886 rheumatoid arthritis patients and 180 Crohn's disease patients. Following this, Gilead filed a request for marketing authorization with the EMA for the approval of filgotinib in UC in … 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. The SELECTION trial is one of multiple clinical studies of filgotinib in a range of inflammatory conditions, including the FINCH Phase 3 program in rheumatoid arthritis, 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial Ann Rheum Dis. 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. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896). To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. Research Clinical trials. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Mod Rheumatol. A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy: Actual Study Start Date : August 8, 2016 k. Gabinet Lekarski Dr. Hab. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Sunshine Hospitals, Clinical Research Centre, Mater Misericordiae University Hospital, Wellcome Trust HRB Clinical Research Facility, Ospedale Clinicizzato SS. and Research Unit, Hepatogastroenterology Unit, University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division, University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division, General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital, Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. 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. Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon, Active tuberculosis (TB) or history of latent TB that has not been treated, Use of any prohibited concomitant medications as described in the study protocol. Objectives To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. The … Study record managers: refer to the Data Element Definitions if submitting registration or results information. Centro Hospitalar e Universitario de Coimbra, E.P.E. N. Med. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS, Uniwersyteckie Centrum Kliniczne im. Why Should I Register and Submit Results? doi: 10.1136/annrheumdis-2020-219214. 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. A phase 2b/3 trial of Gilead Sciences and Galapagos’ filgotinib in ulcerative colitis patients has met its primary endpoint. For general information, Learn About Clinical Studies. Toronto Digestive Disease Associates Inc. Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni, Thomayerova nemocnice, Interni klinika 3. Please remove one or more studies before adding more. Marii Sklodowskiej-Curie, Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie, Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz. Choosing to participate in a study is an important personal decision. Belgyogyaszat - 2. H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.  (Clinical Trial), 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, Experimental: Induction Study (Cohort A): Filgotinib 200 mg, Experimental: Induction Study (Cohort A): Filgotinib 100 mg, Placebo Comparator: Induction Study (Cohort A): Placebo, Experimental: Induction Study (Cohort B): Filgotinib 200 mg, Experimental: Induction Study (Cohort B): Filgotinib 100 mg, Placebo Comparator: Induction Study (Cohort B): Placebo, Experimental: Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 200 mg, Experimental: Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 100 mg, Placebo Comparator: Maintenance Study: Placebo From Induction Placebo, 18 Years to 75 Years   (Adult, Older Adult), Digestive Health Specialists of the Southeast, Scottsdale, Arizona, United States, 85259, Long Beach, California, United States, 90822, Los Angeles, California, United States, 90048, Lone Tree, Colorado, United States, 80124, Farmington, Connecticut, United States, 06032, Gainesville, Florida, United States, 32610, Lakewood Ranch, Florida, United States, 34211, University of Miami Crohn's and Colitis Center, Port Orange, Florida, United States, 32127, Winter Park, Florida, United States, 32789, Zephyrhills, Florida, United States, 33540, Gastroenterology Associates of Central Georgia, LLC, University of Louisville, Clinical Trials Unit, Louisville, Kentucky, United States, 40202, Shreveport, Louisiana, United States, 71105, Annapolis, Maryland, United States, 21401, MGG Group Co., Inc., Chevy Chase Clinical Research, Chevy Chase, Maryland, United States, 20815, Hagerstown, Maryland, United States, 21742, Massachusetts General Hospital - Crohn's and Colitis Center, Boston, Massachusetts, United States, 02114, Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan, United States, 48047, Rochester, Minnesota, United States, 55905, Kansas City, Missouri, United States, 64131, Saint Louis, Missouri, United States, 63110, NYU Langone Long Island Clinical Research Associates, Great Neck, New York, United States, 11021, Raleigh, North Carolina, United States, 27607, Fargo Gastroenterology and Hepatology Clinic, Fargo, North Dakota, United States, 58103, Great Lakes Gastroenterology Research, LLC, Gastroenterology Associates of Orangeburg, Orangeburg, South Carolina, United States, 29118, Rapid City, South Dakota, United States, 57701, Chattanooga, Tennessee, United States, 37421, Germantown, Tennessee, United States, 38138, Nashville, Tennessee, United States, 37211, Vanderbilt University Medical Center - IBD Clinic, Nashville, Tennessee, United States, 37212-1375, Fort Sam Houston, Texas, United States, 78219, Baylor College of Medicine- Baylor Medical Center, The University of Texas Health Science Center at Houston, Clinical Associates in Research Therapeutics of America, LLC, The Woodlands, Texas, United States, 77380, Charlottesville, Virginia, United States, 22908, Chesapeake, Virginia, United States, 23320, Lansdowne Town Center, Virginia, United States, 20176, University of Wisconsin Hospital & Clinics, Wauwatosa, Wisconsin, United States, 53225, Instituto de Investigaciones Clinicas Mar del Plata, Darlinghurst, New South Wales, Australia, 2010, Kingswood, New South Wales, Australia, 2747, Mountain Creek, Queensland, Australia, 4557, South Brisbane, Queensland, Australia, 4101, Woolloongabba, Queensland, Australia, 4102, Woodville South, South Australia, Australia, 5011, Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph, University of Calgary, Heritage Medical Research Clinic, The Gordon and Leslie Diamond Health Care Centre, Vancouver, British Columbia, Canada, V5Z 1M9, Hamilton Health Sciences Corporation, McMaster University Medical Centre.

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