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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03025308
Other study ID # GS-US-417-0304
Secondary ID 2016-003630-25
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 28, 2017
Est. completion date May 2025

Study information

Verified date October 2023
Source Galapagos NV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2731
Est. completion date May 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below: - Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug - OR - Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status - Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE) - Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception Key Exclusion Criteria: - Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator - Known hypersensitivity to the study drug or its excipients - Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily

Locations

Country Name City State
Argentina CIMEL Buenos Aires
Argentina Ceim Investigaciones Medicas Srl Ciudad Autonoma Buenos Aires
Argentina Investigaciones Reumatologicas Y Osteologicas (IRO) SRL Ciudad Autonoma
Argentina Mautalen Salud e Investigación Ciudad Autonoma Buenos Aires
Argentina Onganizacion Medica de Investigacion S.A (OMI) Ciudad Autonoma Buenos Aires
Argentina Consultorios Reumatológicos Pampa Ciudad Autonoma de Buenos Aire
Argentina Instituto De Reumatologia Mendoza
Argentina Instituto Médico Cer Quilmes
Argentina Instituto Iari San Isidro
Argentina Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica San Juan
Argentina Centro Medico Privado de Reumatología San Miguel de Tucuman
Australia Southern Clinical Research Pty Ltd Hobart
Australia Rheumatology Research Unit Maroochydore Queensland
Australia RK Will Pty Ltd Victoria Park Western Australia
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Reumaclinic Genk Genk
Belgium Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg Leuven
Belgium Zna Jan Palfijn Merksem
Bulgaria "Medical Center Help" EOOD Dobrich
Bulgaria "Medical Center- Hipokrat 2000" OOD Haskovo
Bulgaria "UMHAT - Kaspela" EOOD Plovdiv
Bulgaria "MHAT Lyulin" EAD, Department of Rheumatology Sofia
Bulgaria Medical Center "N. I. Pirogov" EOOD Sofia
Bulgaria "DCC Equita" EOOD Varna
Bulgaria MHAT "Sveta Petka" AD, Department of Internal Diseases Vidin
Canada The Waterside Clinic Barrie
Canada Centre De Recherche Musculo Squelettique Trois Rivieres
Chile Quantum Research Santiago Santiago
Chile Someal SA Santiago
Chile Centro Medico De Reumatologia Temuco
Czechia MUDr. Michaela Blahova, revmatologicka ambulance s.r.o. Brno
Czechia L.K.N. Arthrocentrum, s.r.o. Hlucin
Czechia MUDr. Rosypalová, S.R.O. Ostrava-Poruba
Czechia Revmatologicky ustav Prague 2
Czechia Arthrocentrum spol.s.r.o. Prague Praha 10
Czechia Revmatologicka Ambulance Praha 4
Czechia Revmatologicka ambulance, Nuselska Poliklinika Praha 4
Czechia Medical Plus, S.R.O. Uherske Hradiste
France Hôpital Lapeyronie, Service d'Immuno-Rhumatologic Montpellier Cedex 5
Germany Rheumapraxis Dr. med. Reiner Kurthen Aachen
Germany Schlosspark-Klinik Berlin
Germany Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie Frankfurt am Main
Germany HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR Hamburg
Germany Rheumazentrum Ratungen-Studienambulanz GbR Ratingen
Hong Kong Department of Medicine & Theraputics, The Chinese University of Hong Kong Hong Kong
Hong Kong Department of Medicine, Queen Mary Hospital Hong Kong
Hong Kong Tuen Mun Hospital Hong Kong
Hungary Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz Budapest
Hungary Revita Reumatológiai Kft. Budapest
Hungary Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly Eger
Hungary Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly Gyula
Hungary Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh Kalocsa
Hungary Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly Kistarcsa
Hungary C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia Székesfehérvár
Hungary Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly Szentes
India B.J. Medical College and Civil Hospital Ahmedabad
India Panchshil Hospital, Dep Ahmedabad
India Chanre Rheumatology and Immunology Centre and Research Bangalore
India Chennai Meenakshi Multispeciality Hospital Ltd Chennai
India All India Institute of Medical Sciences Delhi
India Medanta - The Medicity Gurgaon
India Gleneagles Global Hospitals Hyderabad
India Nizams Institute of Medical Sciences Hyderabad
India Santokba Durlabhji Memorial Hospital Cum Medical Research Institute Jaipur
India Shri Nidaan Hospital and Hope Fertility Centre Jaipur
India SR Kalla Memorial Gastro and General Hospital Jaipur
India Apollo Gleneagles Hospitals, Kolkata Kolkata
India Medical College & Hospital, Kolkata Kolkata
India Department of Rheumatology, KG Medical University Lucknow
India Kasturba Medical College Hospital Mangalore
India Vinaya Hospital and Research Centre Mangalore
India JSS Medical College and Hospital Mysuru
India Suretech Hospital and Research Centre Pvt Ltd Nagpur
India Maharaja Agrasen Hospital New Delhi
India Sir Ganga Ram Hospital New Delhi
India Centre for Rheumatic Disease, Hermes Doctor House Pune
India Deenanath Mangeshkar Hospital and Research Centre Pune
India Krishna Institute of Medical Sciences Secunderabad
India Rajiv Gandhi Institute of Medical Sciences and Government General Hospital Srikakulam
India Nirmal Hospital Private Limited Surat
India Medical College Baroda and Sir Sayajirao General Hospital Vadodara
India King George Hospital Visakhapatnam
Ireland St Vincent's University Hospital Dublin
Israel Bnai Zion Medical Center Haifa
Israel The Lady Davis Carmel Medical Center Haifa
Israel Rabin Medical Center Petah Tikva
Israel The Chaim Sheba Medical Center Ramat Gan
Israel Tel Aviv Medical Center Tel Aviv
Italy Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso Bologna
Italy Reumatologia Milano
Japan Chiba University Hospital Chiba-shi
Japan Kyushu Medical Center Fukuoka
Japan National Hospital Organization Kyushu Medical Center Fukuoka
Japan Seirei Hamamatsu General Hospital Hamamatsu
Japan Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital Hiroshima
Japan Hiroshima University Hospital Hiroshima
Japan Hiroshima Rheumatology Clinic Hiroshima-shi
Japan Iizuka Hospital Iizuka-shi
Japan Saitama Medical University Hospital Iruma-gun
Japan Shimane University Hospital Izumo
Japan Kagoshima red cross hospital Kagoshima-shi
Japan Matsubara Mayflower Hospital Kato
Japan Saitama Medical Center Kawagoe
Japan Hospital of the University of Occupational and Environmental Health, Japan Kitakyushu-shi
Japan Kobe University Hospital Kobe
Japan Kumamoto Orthopaedic Hospital Kumamoto-shi
Japan Kurume University Medical Center Kurume-shi
Japan University Hospital, Kyoto Prefectural University of Medicine Kyoto
Japan Kyoto University Hospital Kyoto-shi
Japan Yu Family Clinic Miyagi-gun
Japan Zenjinkai Shiminnnomori Hospital Miyazaki
Japan Yoshida orthopaedic and rheumatology Clinic Morioka-shi
Japan Nagaoka Red Cross Hospital Nagaoka
Japan Nagasaki Medical Hospital of Rheumatology Nagasaki-shi
Japan Nagoya University Hospital Nagoya
Japan Chibaken Saiseikai Narashino Hospital Narashino Chiba
Japan The Hospital of Hyogo College of Medine Nishinomiya
Japan Okayama University Hospital Okayama
Japan Okayama Saiseikai General Hospital Outpatient Center Okayama-city
Japan Ome Municipal General Hospital Ome
Japan National Hospital Organization Sagamihara National Hospital Sagamihara
Japan Sanuki Municipal Hospital Sanuki-shi
Japan Hokkaido Medical Center for Rheumatic Diseases Sapporo
Japan Hokkaido University Hospital Sapporo
Japan Sagawa Akira Rheumatology Clinic Sapporo
Japan Sapporo City General Hospital Sapporo
Japan Sasebo Chuo Hospital Sasebo-shi
Japan Azuma Rheumatology Clinic Sayama-shi
Japan Niigata Rheumatic Center Shibata-City
Japan Shizuoka Welfare Hospital Shizuoka
Japan Osaka University Hospital Suita-shi
Japan Honjo Rheumatism Clinic Takaoka Toyama
Japan Inoue Hospital Takasaki-shi
Japan Medical Corporation Kojyokai Hirose Clinic Tokorozawa Saitama
Japan Keio University Hospital Tokyo
Japan Medical Corporation Uchida Clinic Tokyo
Japan Setagaya Rheumatic Clinic Tokyo
Japan Showa University East Hospital Tokyo
Japan St. Luke's International Hospital Tokyo
Japan Teikyo University Hospital Tokyo
Japan Toho University Ohashi Medical Center Tokyo
Japan Toho University Omori Medical Center Tokyo
Japan Yuuai Medical Center Tomigusuku-shi
Japan University of Tsukuba Hospital Tsukuba-shi
Japan Wakayama Medical University Hospital Wakayama
Japan Yokohama Minami Kyousai Hospital Yokohama-shi
Korea, Republic of Pusan National University Hospital Busan-si
Korea, Republic of Daegu Catholic University Medical Center Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Eulji University Hospital Daejeon
Korea, Republic of Chonnam National University Hospital Gwangju
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of Chonbuk National University Medical School Jeonju
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Chung-Ang University Hospital Institutional Review Board Seoul
Korea, Republic of Hanyang University Seoul Hospital Seoul
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of SMG-SNU Boramae Medical Center Seoul
Malaysia Hospital Selayang Batu Caves Selangor
Malaysia University Malaya Medical Centre Kuala Lumpur
Mexico Investigacion y Biomedicina de Chihuahua, S.C. Chihuahua
Mexico Clinstile, S.A. De C.V. Ciudad de Mexico
Mexico Clinosar Mexico. S.A. de C. V. Ciudad de México
Mexico Centro Peninsular De Investigacion Clinica S.C.P. Merida
Mexico Kohler & Milstein Research S.A. de C.V. Mérida Yucatan
Mexico Biologicos Especializados Mexico
Mexico Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey
Mexico Centro De Investigación Clínica De Morelia, Sc Morelia Michoacan
New Zealand Optimal Clinical Trials, Level 2 Auckland
New Zealand Waikato Hospital Hamilton
New Zealand Clinical Trial Unit, CCHDB, Wellington Hospital Newtown
New Zealand Middlemore Clinical Trial Papatoetoe Auckland
New Zealand Clinical Trials Unit, Timaru Hospital Timaru
Poland Clinicmed Bialystok
Poland Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk Bialystok
Poland Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej Bydgoszcz
Poland Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C. Bytom
Poland Nszoz Unica Cr Dabrówka
Poland Centrum Kliniczno-Badawcze J. Brzezicki Elblag
Poland Centrum Medyczne Pratia Gdynia Gdynia
Poland NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach Kartuzy
Poland SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach Katowice
Poland Nzoz Centrum Medyczne Promimed Krakow
Poland Twoja Przychodnia -Centrum Medyzcne Nowa Sol Nowa Sol
Poland Ai Centrum Medyczne Poznan
Poland Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski Poznan
Poland Synexus Polska Sp. z.o.o. Oddzial w Porznaniu Poznan
Poland Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy Tomaszów Lubelski
Poland Nasz Lekarz Przychodnie Medyczne Torun
Poland Centrum Medyczne AMED Warszawa Targówek Warszawa
Poland Reumatika -Centrum Reumatologii NZOZ Warszawa
Poland Centrum Medyczne Oporow Wroclaw
Romania Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie Bacau
Romania S.C. Ianuli Med Consult S.R.L. Bucuresti
Romania Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie Bucuresti
Romania Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie Bucuresti
Romania Spitalul Clinic Judetean de Urgenta Tirgu Mures Targu-Mures
Russian Federation Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital" Barnaul
Russian Federation State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital Chelyabinsk
Russian Federation FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy Kazan
Russian Federation Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans Kemerovo
Russian Federation Medical Center Maximum Zdorovia LLC Kemerovo
Russian Federation City Clinical Hospital #4 of Department of Healthcare of Moscow City Moscow
Russian Federation M. Vladimirsky Moscow Regional Research Clinical Institute Moscow
Russian Federation Municipal Clinical Hospital No. 15 named after O.M. Filatov Moscow
Russian Federation Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City Moscow
Russian Federation Nizhny Novgorod City Clinical Hospital #5 Nizhny Novgorod
Russian Federation Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25" Saint Petersburg
Russian Federation State Healthcare Institution, Regional Clinical Hospital Saratov
Russian Federation LLC Polyclinic of Private Security Personnel St.Petersburg
Russian Federation LLC BioMed Vladimir
Russian Federation State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev" Yaroslavl
Serbia Clinical Hospital Center Bezanijska Kosa Belgrade
Serbia Institute Of Rheumatology Belgrade
Serbia Military Medical Academy, Clinic of Rheumatology Belgrade
Serbia Institute For Treatment And Rehabilitation Niska Banja Niska Banja
Slovakia Neštátna Reumatologická Ambulancia Bratislava
Slovakia Reumex S.R.O. Rimavská Sobota
Slovakia LERAM s.r.o. Topolcany
South Africa Arthritis Clinical Trial Centre Cape Town
South Africa Netcare St. Augustine's Hospital Durban
South Africa Umhlanga Netcare Medical Centre Durban
South Africa Charlotte Maxeke Johannesburg Academic Hospital Johannesburg
South Africa Winelands Medical Research Centre Stellenbosch
Spain Hospital Universitario Cruces Barakaldo
Spain Complejo Hospitalario Universitario de Santiago La Coruña
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Regional Universitario de Malaga Málaga
Spain Corporacio Santiaria Parc Tauli Sabadell
Spain Clínica Gaias Santiago de Compostela
Spain Hospital HM Nuestra Senora de la Esperanza Santiago de Compostela
Spain Hospital Clinico Universitario de Valencia Valencia
Taiwan Changhua Christian Hospital Changhua City
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Chang Gung Memorial Hospital, Keelung Keelung
Taiwan Chung Shan Medical University Hospital Taichung
Taiwan China Medical University Hospital Taichung City
Taiwan Chi Mei Hospital, Chi Mei Medical Center Tainan City
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Medical University Hospital Taipei
Taiwan Tri-Service General Hospital Taipei
Taiwan Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch Taoyuan
Thailand Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine Bangkok
Thailand Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine Bangkok
Thailand Rajavithi Hospital, Rheumatology and Allergy Unit Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University Chiangmai
Thailand Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital Songkla
Ukraine Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council Dnipro
Ukraine Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine" Kharkiv
Ukraine Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy Kharkiv
Ukraine Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1 Kharkiv
Ukraine State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine" Kharkiv
Ukraine Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1 Kherson
Ukraine Kyiv City Clinical Hospital #6, Department of Therapy Kyiv
Ukraine Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2 Kyiv
Ukraine Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department Kyiv
Ukraine State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine Kyiv
Ukraine Lutsk City Clinical Hospital Lutsk
Ukraine Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology Lviv
Ukraine Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology Lviv
Ukraine Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department Odesa
Ukraine City Clinical Hospital #1, Department of Rheumatology Vinnytsia
Ukraine Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology Vinnytsya
Ukraine Medical Centre Modern Clinic, LLC Zaporizhzhya
Ukraine Municipal Institution "City Hospital #1", Department of Therapy Zaporizhzhya
Ukraine Municipal Institution City Hospital #7, Department of Therapy Zaporizhzhya
United Kingdom NHS Lothian, Western General Hospital Edinburgh
United Kingdom Princess Alexandra Hospital Harlow
United Kingdom Northumbria Healthcare NHS Foundation Trust North Shields
United Kingdom Warrington and Halton Hospitals Nhs Foundation Trust Warrington
United States Albuquerque Clinical Trials, Inc. Albuquerque New Mexico
United States AARDS Research, Inc. Aventura Florida
United States Diagnostic Group Beaumont Texas
United States East Penn Rheumatology Associates Bethlehem Pennsylvania
United States NYU Langone Ambulatory Care Brooklyn Heights Brooklyn New York
United States Weill Cornell Physicians At Brooklyn Heights Brooklyn New York
United States Trinity Universal Research Associates, Inc Carrollton Texas
United States Joint And Muscle Research Institute Charlotte North Carolina
United States Clinical Research of West Florida, Inc. Clearwater Florida
United States Articularis Healthcare Inc., dba Columbia Arthritis Center, PA Columbia South Carolina
United States Adriana Pop-Moody MD Clinic PA Corpus Christi Texas
United States Medvin Clinical Research Covina California
United States Klein & Associates, M.D., P.A. Cumberland Maryland
United States Arthritis Centers Of Texas Dallas Texas
United States Omega Research Consultants, LLC DeBary Florida
United States Jefrey D. Lieberman, MD, P.C. Decatur Georgia
United States Henry Ford Health System Detroit Michigan
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States St. Paul Rheumatology, PA Eagan Minnesota
United States Center For Arthritis and Osteoporosis Elizabethtown Kentucky
United States Arthritis Treatment Center Frederick Maryland
United States Arthritis & Osteoporosis Associates Freehold New Jersey
United States Arthrocare, Arthritis Care & Research PC Gilbert Arizona
United States Physicians East, PA Greenville North Carolina
United States Klein & Associates, M.D., P.A. Hagerstown Maryland
United States Arthritis Associates, PLLC Hattiesburg Mississippi
United States C.V. Mehta M.D. Medical Corporation Hemet California
United States Rheumatology Associates of North Alabama, PC Huntsville Alabama
United States University of Florida College of Medicine, Jacksonville - Rheumatology Research Jacksonville Florida
United States University of Kansas Medical Center Kansas City Kansas
United States University of California San Diego (UCSD) - Perlman Ambulatory Clinic La Jolla California
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Bluegrass Community Research, Inc. Lexington Kentucky
United States Physician Research Collaboration, LLC Lincoln Nebraska
United States Keck Medicine of USC- Division of Rheumatology Los Angeles California
United States Ramesh C. Gupta, M.D. Memphis Tennessee
United States Southwest Rheumatology Research, LLC Mesquite Texas
United States Suncoast Research Group, LLC Miami Florida
United States San Marcus Research Clinic, Inc. Miami Lakes Florida
United States Paramount Medical Research & Consulting, LLC Middleburg Heights Ohio
United States Carolina Rheumatology & Neurology Assoc., PC Myrtle Beach South Carolina
United States Suncoast Clinical Research, Inc. New Port Richey Florida
United States Health Research of Oklahoma Oklahoma City Oklahoma
United States Articularis Healthcare Group d/b/a ACME Research Orangeburg South Carolina
United States Omega Research Consultants LLC Orlando Florida
United States Desert Medical Advances Palm Desert California
United States Stanford University Hospitals and Clinics (Immunology & Rheumatology) Palo Alto California
United States Arthritis Group, PC Philadelphia Pennsylvania
United States Arizona Arthritis & Rheumatology Associates, P.C. Phoenix Arizona
United States Trinity Universal Research Associates, Inc Plano Texas
United States IRIS Research and Development, LLC Plantation Florida
United States C.V. Mehta Medical Corporation Riverside California
United States Shores Rheumatology, PC Saint Clair Shores Michigan
United States Arthritis Consultants, Inc. Saint Louis Missouri
United States Clayton Medical Research, P.C. Saint Louis Missouri
United States PMG Research of Salisbury Salisbury North Carolina
United States Arthritis & Osteoporosis Center of South Texas San Antonio Texas
United States Springfield Clinic Springfield Illinois
United States Articularis Healthcare Group d/b/a Low Country Rheumatology Summerville South Carolina
United States Ocean Rheumatology, PA Toms River New Jersey
United States Arizona Arthritis & Rheumatology Associates, P.C. Tucson Arizona
United States The Oklahoma Center For Arthritis Therapy & Research, Inc. Tulsa Oklahoma
United States North Mississippi Medical Clinics, Inc. Tupelo Mississippi
United States Inland Rheumatology Clinical Trials, Inc. Upland California
United States Desert Valley Medical Group Victorville California
United States The Center For Rheumatology And Bone Research Wheaton Maryland
United States Medvin Clinical Research Whittier California
United States Heartland Research Associates, LLC Wichita Kansas
United States Clinical Pharmacology Study Group Worcester Massachusetts
United States Umass Memorial Medical Center- Memorial Campus Worcester Massachusetts
United States Clinical Research Center of Reading LLC Wyomissing Pennsylvania
United States PA Regional Center For Arthritis And Osteoporosis Research Wyomissing Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Galapagos NV Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  Chile,  Czechia,  France,  Germany,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  New Zealand,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants Experiencing Adverse Events (AEs) Up to 6 years
Primary Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities Up to 6 years
Secondary Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm Up to 6 years
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