Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

NCT ID: NCT03025308

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2731 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Study Completion Date

2025-05-16

Brief Summary

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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).

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This study was originally designed and initiated as a double-blind study but the study design will change to open-label following implementation of the protocol amendment # 4.

Study Groups

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Blinded Phase: Filgotinib 200 mg

Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years

Group Type EXPERIMENTAL

Filgotinib

Intervention Type DRUG

Tablet(s) administered orally once daily

Placebo to match filgotinib

Intervention Type DRUG

Tablet(s) administered orally once daily

Blinded Phase: Filgotinib 100 mg

Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years

Group Type EXPERIMENTAL

Filgotinib

Intervention Type DRUG

Tablet(s) administered orally once daily

Placebo to match filgotinib

Intervention Type DRUG

Tablet(s) administered orally once daily

Open Label Phase: Filgotinib 200 mg

Filgotinib 200 mg for up to 6 years

Group Type EXPERIMENTAL

Filgotinib

Intervention Type DRUG

Tablet(s) administered orally once daily

Open Label Phase: Filgotinib 100 mg

Filgotinib 100 mg for up to 6 years

Group Type EXPERIMENTAL

Filgotinib

Intervention Type DRUG

Tablet(s) administered orally once daily

Interventions

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Filgotinib

Tablet(s) administered orally once daily

Intervention Type DRUG

Placebo to match filgotinib

Tablet(s) administered orally once daily

Intervention Type DRUG

Other Intervention Names

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GS-6034 GLPG0634

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Alfasigma S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfasigma Study Director

Role: STUDY_DIRECTOR

Alfasigma S.p.A.

Locations

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Rheumatology Associates of North Alabama, PC

Huntsville, Alabama, United States

Site Status

Arthrocare, Arthritis Care & Research PC

Gilbert, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States

Site Status

Arizona Arthritis & Rheumatology Associates, P.C.

Tucson, Arizona, United States

Site Status

Medvin Clinical Research

Covina, California, United States

Site Status

C.V. Mehta M.D. Medical Corporation

Hemet, California, United States

Site Status

University of California San Diego (UCSD) - Perlman Ambulatory Clinic

La Jolla, California, United States

Site Status

Keck Medicine of USC- Division of Rheumatology

Los Angeles, California, United States

Site Status

Desert Medical Advances

Palm Desert, California, United States

Site Status

Stanford University Hospitals and Clinics (Immunology & Rheumatology)

Palo Alto, California, United States

Site Status

C.V. Mehta Medical Corporation

Riverside, California, United States

Site Status

Inland Rheumatology Clinical Trials, Inc.

Upland, California, United States

Site Status

Desert Valley Medical Group

Victorville, California, United States

Site Status

Medvin Clinical Research

Whittier, California, United States

Site Status

AARDS Research, Inc.

Aventura, Florida, United States

Site Status

Clinical Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status

Omega Research Consultants, LLC

DeBary, Florida, United States

Site Status

University of Florida College of Medicine, Jacksonville - Rheumatology Research

Jacksonville, Florida, United States

Site Status

Suncoast Research Group, LLC

Miami, Florida, United States

Site Status

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Omega Research Consultants LLC

Orlando, Florida, United States

Site Status

IRIS Research and Development, LLC

Plantation, Florida, United States

Site Status

Jefrey D. Lieberman, MD, P.C.

Decatur, Georgia, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Center For Arthritis and Osteoporosis

Elizabethtown, Kentucky, United States

Site Status

Bluegrass Community Research, Inc.

Lexington, Kentucky, United States

Site Status

Klein & Associates, M.D., P.A.

Cumberland, Maryland, United States

Site Status

Arthritis Treatment Center

Frederick, Maryland, United States

Site Status

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, United States

Site Status

The Center For Rheumatology And Bone Research

Wheaton, Maryland, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

Umass Memorial Medical Center- Memorial Campus

Worcester, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Shores Rheumatology, PC

Saint Clair Shores, Michigan, United States

Site Status

St. Paul Rheumatology, PA

Eagan, Minnesota, United States

Site Status

Arthritis Associates, PLLC

Hattiesburg, Mississippi, United States

Site Status

North Mississippi Medical Clinics, Inc.

Tupelo, Mississippi, United States

Site Status

Clayton Medical Research, P.C.

St Louis, Missouri, United States

Site Status

Arthritis Consultants, Inc.

St Louis, Missouri, United States

Site Status

Physician Research Collaboration, LLC

Lincoln, Nebraska, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Arthritis & Osteoporosis Associates

Freehold, New Jersey, United States

Site Status

Ocean Rheumatology, PA

Toms River, New Jersey, United States

Site Status

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, United States

Site Status

NYU Langone Ambulatory Care Brooklyn Heights

Brooklyn, New York, United States

Site Status

Weill Cornell Physicians At Brooklyn Heights

Brooklyn, New York, United States

Site Status

Joint And Muscle Research Institute

Charlotte, North Carolina, United States

Site Status

Physicians East, PA

Greenville, North Carolina, United States

Site Status

PMG Research of Salisbury

Salisbury, North Carolina, United States

Site Status

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States

Site Status

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

The Oklahoma Center For Arthritis Therapy & Research, Inc.

Tulsa, Oklahoma, United States

Site Status

East Penn Rheumatology Associates

Bethlehem, Pennsylvania, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Arthritis Group, PC

Philadelphia, Pennsylvania, United States

Site Status

Clinical Research Center of Reading LLC

Wyomissing, Pennsylvania, United States

Site Status

PA Regional Center For Arthritis And Osteoporosis Research

Wyomissing, Pennsylvania, United States

Site Status

Articularis Healthcare Inc., dba Columbia Arthritis Center, PA

Columbia, South Carolina, United States

Site Status

Carolina Rheumatology & Neurology Assoc., PC

Myrtle Beach, South Carolina, United States

Site Status

Articularis Healthcare Group d/b/a ACME Research

Orangeburg, South Carolina, United States

Site Status

Articularis Healthcare Group d/b/a Low Country Rheumatology

Summerville, South Carolina, United States

Site Status

Ramesh C. Gupta, M.D.

Memphis, Tennessee, United States

Site Status

Diagnostic Group

Beaumont, Texas, United States

Site Status

Trinity Universal Research Associates, Inc

Carrollton, Texas, United States

Site Status

Adriana Pop-Moody MD Clinic PA

Corpus Christi, Texas, United States

Site Status

Arthritis Centers Of Texas

Dallas, Texas, United States

Site Status

Southwest Rheumatology Research, LLC

Mesquite, Texas, United States

Site Status

Trinity Universal Research Associates, Inc

Plano, Texas, United States

Site Status

Arthritis & Osteoporosis Center of South Texas

San Antonio, Texas, United States

Site Status

Ceim Investigaciones Medicas Srl

Ciudad Autonoma, Buenos Aires, Argentina

Site Status

CIMEL

Buenos Aires, , Argentina

Site Status

Onganizacion Medica de Investigacion S.A (OMI)

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Mautalen Salud e Investigación

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Consultorios Reumatológicos Pampa

Ciudad Autonoma de Buenos Aire, , Argentina

Site Status

Investigaciones Reumatologicas Y Osteologicas (IRO) SRL

Ciudad Autonoma, , Argentina

Site Status

Instituto De Reumatologia

Mendoza, , Argentina

Site Status

Instituto Médico Cer

Quilmes, , Argentina

Site Status

Instituto Iari

San Isidro, , Argentina

Site Status

Cer San Juan, Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, , Argentina

Site Status

Centro Medico Privado de Reumatología

San Miguel de Tucumán, , Argentina

Site Status

Rheumatology Research Unit

Maroochydore, Queensland, Australia

Site Status

RK Will Pty Ltd

Victoria Park, Western Australia, Australia

Site Status

Southern Clinical Research Pty Ltd

Hobart, , Australia

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Reumaclinic Genk

Genk, , Belgium

Site Status

Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

Leuven, , Belgium

Site Status

Zna Jan Palfijn

Merksem, , Belgium

Site Status

"Medical Center Help" EOOD

Dobrich, , Bulgaria

Site Status

"Medical Center- Hipokrat 2000" OOD

Haskovo, , Bulgaria

Site Status

"UMHAT - Kaspela" EOOD

Plovdiv, , Bulgaria

Site Status

"MHAT Lyulin" EAD, Department of Rheumatology

Sofia, , Bulgaria

Site Status

Medical Center "N. I. Pirogov" EOOD

Sofia, , Bulgaria

Site Status

"DCC Equita" EOOD

Varna, , Bulgaria

Site Status

MHAT "Sveta Petka" AD, Department of Internal Diseases

Vidin, , Bulgaria

Site Status

The Waterside Clinic

Barrie, , Canada

Site Status

Centre De Recherche Musculo Squelettique

Trois-Rivières, , Canada

Site Status

Quantum Research Santiago

Santiago, , Chile

Site Status

Someal SA

Santiago, , Chile

Site Status

Centro Medico De Reumatologia

Temuco, , Chile

Site Status

MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.

Brno, , Czechia

Site Status

L.K.N. Arthrocentrum, s.r.o.

Hlučín, , Czechia

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MUDr. Rosypalová, S.R.O.

Ostrava-Poruba, , Czechia

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Revmatologicky ustav

Prague, , Czechia

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Revmatologicka Ambulance

Prague, , Czechia

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Revmatologicka ambulance, Nuselska Poliklinika

Prague, , Czechia

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Arthrocentrum spol.s.r.o.

Prague Praha 10, , Czechia

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Medical Plus, S.R.O.

Uherské Hradiště, , Czechia

Site Status

Hôpital Lapeyronie, Service d'Immuno-Rhumatologic

Montpellier, , France

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Rheumapraxis Dr. med. Reiner Kurthen

Aachen, , Germany

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Schlosspark-Klinik

Berlin, , Germany

Site Status

Centrum f. inn. Diagn. und Therap. Rheumatologie/Immunologie

Frankfurt am Main, , Germany

Site Status

HRF II, Hamburger Rheuma Forsch. Zentrum II, MVZ f. Rheumatologie und Autoimmuned. Hamb. GmbH/ Dr. A. Everding GbR

Hamburg, , Germany

Site Status

Rheumazentrum Ratungen-Studienambulanz GbR

Ratingen, , Germany

Site Status

Department of Medicine & Theraputics, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Department of Medicine, Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Tuen Mun Hospital

Hong Kong, , Hong Kong

Site Status

Betegapolo-Irgalmasrend Budai Irgalmasrendi Korhaz

Budapest, , Hungary

Site Status

Revita Reumatológiai Kft.

Budapest, , Hungary

Site Status

Markhot Ferenc Oktatokorhaz es Rendelointezet; Reumatologiai Osztaly

Eger, , Hungary

Site Status

Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Reumatologiai Osztaly

Gyula, , Hungary

Site Status

Bacs Kiskun Megyei Korhaz Szedgedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktatokorhaz Kalocsai Szent Kereszt Korh

Kalocsa, , Hungary

Site Status

Pest Megyei Flor Ferenc Korhaz, Reumatologiai-es Fizioterapias Osztaly

Kistarcsa, , Hungary

Site Status

Csongrad Megyei Dr. Bugyi Istvan Korhaz; Mozgasszervi Rehabilitacios Osztaly

Szentes, , Hungary

Site Status

C-Med Rehabilitacios es Diagnosztikai Kozpont. Reumatologia

Székesfehérvár, , Hungary

Site Status

Panchshil Hospital, Dep

Ahmedabad, , India

Site Status

B.J. Medical College and Civil Hospital

Ahmedabad, , India

Site Status

Chanre Rheumatology and Immunology Centre and Research

Bangalore, , India

Site Status

Chennai Meenakshi Multispeciality Hospital Ltd

Chennai, , India

Site Status

All India Institute of Medical Sciences

Delhi, , India

Site Status

Medanta - The Medicity

Gurgaon, , India

Site Status

Gleneagles Global Hospitals

Hyderabad, , India

Site Status

Nizams Institute of Medical Sciences

Hyderabad, , India

Site Status

Shri Nidaan Hospital and Hope Fertility Centre

Jaipur, , India

Site Status

SR Kalla Memorial Gastro and General Hospital

Jaipur, , India

Site Status

Santokba Durlabhji Memorial Hospital Cum Medical Research Institute

Jaipur, , India

Site Status

Apollo Gleneagles Hospitals, Kolkata

Kolkata, , India

Site Status

Medical College & Hospital, Kolkata

Kolkata, , India

Site Status

Department of Rheumatology, KG Medical University

Lucknow, , India

Site Status

Kasturba Medical College Hospital

Mangalore, , India

Site Status

Vinaya Hospital and Research Centre

Mangalore, , India

Site Status

JSS Medical College and Hospital

Mysuru, , India

Site Status

Suretech Hospital and Research Centre Pvt Ltd

Nagpur, , India

Site Status

Maharaja Agrasen Hospital

New Delhi, , India

Site Status

Sir Ganga Ram Hospital

New Delhi, , India

Site Status

Centre for Rheumatic Disease, Hermes Doctor House

Pune, , India

Site Status

Deenanath Mangeshkar Hospital and Research Centre

Pune, , India

Site Status

Krishna Institute of Medical Sciences

Secunderabad, , India

Site Status

Rajiv Gandhi Institute of Medical Sciences and Government General Hospital

Srikakulam, , India

Site Status

Nirmal Hospital Private Limited

Surat, , India

Site Status

Medical College Baroda and Sir Sayajirao General Hospital

Vadodara, , India

Site Status

King George Hospital

Visakhapatnam, , India

Site Status

St Vincent's University Hospital

Dublin, , Ireland

Site Status

Bnai Zion Medical Center

Haifa, , Israel

Site Status

The Lady Davis Carmel Medical Center

Haifa, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

Site Status

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Departimento Cardio-toraco-vascolare Gestione delle Malattie Reumatiche e del Connettivo e Malattie Metaboliche dell'osso

Bologna, Bologna, Italy

Site Status

Reumatologia

Milan, , Italy

Site Status

Chibaken Saiseikai Narashino Hospital

Narashino, Chiba, Japan

Site Status

Medical Corporation Kojyokai Hirose Clinic

Tokorozawa, Saitama, Japan

Site Status

Honjo Rheumatism Clinic

Takaoka, Toyama, Japan

Site Status

Chiba University Hospital

Chiba, , Japan

Site Status

Kyushu Medical Center

Fukuoka, , Japan

Site Status

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Site Status

Seirei Hamamatsu General Hospital

Hamamatsu, , Japan

Site Status

Hiroshima Rheumatology Clinic

Hiroshima, , Japan

Site Status

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, , Japan

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

Iizuka Hospital

Iizuka-shi, , Japan

Site Status

Saitama Medical University Hospital

Iruma-gun, , Japan

Site Status

Shimane University Hospital

Izumo, , Japan

Site Status

Kagoshima red cross hospital

Kagoshima, , Japan

Site Status

Matsubara Mayflower Hospital

Katō, , Japan

Site Status

Saitama Medical Center

Kawagoe, , Japan

Site Status

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-shi, , Japan

Site Status

Kobe University Hospital

Kobe, , Japan

Site Status

Kumamoto Orthopaedic Hospital

Kumamoto, , Japan

Site Status

Kurume University Medical Center

Kurume-shi, , Japan

Site Status

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Yu Family Clinic

Miyagi-gun, , Japan

Site Status

Zenjinkai Shiminnnomori Hospital

Miyazaki, , Japan

Site Status

Yoshida orthopaedic and rheumatology Clinic

Morioka, , Japan

Site Status

Nagaoka Red Cross Hospital

Nagaoka, , Japan

Site Status

Nagasaki Medical Hospital of Rheumatology

Nagasaki, , Japan

Site Status

Nagoya University Hospital

Nagoya, , Japan

Site Status

The Hospital of Hyogo College of Medine

Nishinomiya, , Japan

Site Status

Okayama Saiseikai General Hospital Outpatient Center

Okayama, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

Ome Municipal General Hospital

Ōme, , Japan

Site Status

National Hospital Organization Sagamihara National Hospital

Sagamihara, , Japan

Site Status

Sanuki Municipal Hospital

Sanuki-shi, , Japan

Site Status

Sagawa Akira Rheumatology Clinic

Sapporo, , Japan

Site Status

Sapporo City General Hospital

Sapporo, , Japan

Site Status

Hokkaido University Hospital

Sapporo, , Japan

Site Status

Hokkaido Medical Center for Rheumatic Diseases

Sapporo, , Japan

Site Status

Sasebo Chuo Hospital

Sasebo-shi, , Japan

Site Status

Azuma Rheumatology Clinic

Sayama-shi, , Japan

Site Status

Niigata Rheumatic Center

Shibata, , Japan

Site Status

Shizuoka Welfare Hospital

Shizuoka, , Japan

Site Status

Osaka University Hospital

Suita-shi, , Japan

Site Status

Inoue Hospital

Takasaki-shi, , Japan

Site Status

St. Luke's International Hospital

Tokyo, , Japan

Site Status

Medical Corporation Uchida Clinic

Tokyo, , Japan

Site Status

Showa University East Hospital

Tokyo, , Japan

Site Status

Toho University Omori Medical Center

Tokyo, , Japan

Site Status

Toho University Ohashi Medical Center

Tokyo, , Japan

Site Status

Setagaya Rheumatic Clinic

Tokyo, , Japan

Site Status

Keio University Hospital

Tokyo, , Japan

Site Status

Teikyo University Hospital

Tokyo, , Japan

Site Status

Yuuai Medical Center

Tomigusuku-shi, , Japan

Site Status

University of Tsukuba Hospital

Tsukuba, , Japan

Site Status

Wakayama Medical University Hospital

Wakayama, , Japan

Site Status

Yokohama Minami Kyousai Hospital

Yokohama, , Japan

Site Status

Hospital Selayang

Batu Caves, Selangor, Malaysia

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Centro De Investigación Clínica De Morelia, Sc

Morelia, Michoacán, Mexico

Site Status

Kohler & Milstein Research S.A. de C.V.

Mérida, Yucatán, Mexico

Site Status

Investigacion y Biomedicina de Chihuahua, S.C.

Chihuahua City, , Mexico

Site Status

Clinstile, S.A. De C.V.

Mexico City, , Mexico

Site Status

Clinosar Mexico. S.A. de C. V.

Mexico City, , Mexico

Site Status

Centro Peninsular De Investigacion Clinica S.C.P.

Mérida, , Mexico

Site Status

Biologicos Especializados

México, , Mexico

Site Status

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, , Mexico

Site Status

Middlemore Clinical Trial

Papatoetoe, Auckland, New Zealand

Site Status

Optimal Clinical Trials, Level 2

Auckland, , New Zealand

Site Status

Waikato Hospital

Hamilton, , New Zealand

Site Status

Clinical Trial Unit, CCHDB, Wellington Hospital

Newtown, , New Zealand

Site Status

Clinical Trials Unit, Timaru Hospital

Timaru, , New Zealand

Site Status

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, , Poland

Site Status

Clinicmed

Bialystok, , Poland

Site Status

Szpital Uniwersytecki Nr 2, Klinka Reumatologii I Ukladowych Chorob Tkanki Lacznej

Bydgoszcz, , Poland

Site Status

Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C.

Bytom, , Poland

Site Status

Nszoz Unica Cr

Dabrówka, , Poland

Site Status

Centrum Kliniczno-Badawcze J. Brzezicki

Elblag, , Poland

Site Status

Centrum Medyczne Pratia Gdynia

Gdynia, , Poland

Site Status

NZOZ Centrum Medyczna Sw. Lukasza w Kartuzach

Kartuzy, , Poland

Site Status

SILMEDIC Spolka z ograniczona odpowiedzialnoscia w Swindniku, Oddzial w Katowicach

Katowice, , Poland

Site Status

Nzoz Centrum Medyczne Promimed

Krakow, , Poland

Site Status

Twoja Przychodnia -Centrum Medyzcne Nowa Sol

Nowa Sól, , Poland

Site Status

Synexus Polska Sp. z.o.o. Oddzial w Porznaniu

Poznan, , Poland

Site Status

Centrum Badan Klinicznych S.C. Wieslawa Porawska, Lukasz Porawski

Poznan, , Poland

Site Status

Ai Centrum Medyczne

Poznan, , Poland

Site Status

Samodzielny Publiczny Zespol Opieki Zdrowotnej w Tomaszowie Lubelskim Lubelskim; Oddzial Reumatologiczy

Tomaszów Lubelski, , Poland

Site Status

Nasz Lekarz Przychodnie Medyczne

Torun, , Poland

Site Status

Reumatika -Centrum Reumatologii NZOZ

Warsaw, , Poland

Site Status

Centrum Medyczne AMED Warszawa Targówek

Warsaw, , Poland

Site Status

Centrum Medyczne Oporow

Wroclaw, , Poland

Site Status

Spitalul Judetean de Urgenta Bacau, Sectia Reumatologie

Bacau, , Romania

Site Status

S.C. Ianuli Med Consult S.R.L.

Bucharest, , Romania

Site Status

Spitalul Clinic ,, Sf. Maria", Sectia Reumatologie

Bucharest, , Romania

Site Status

Spitalul Clinic,, Sf. Maria"", Departamentul de Medicina Interna si Reumatologie

Bucharest, , Romania

Site Status

Spitalul Clinic Judetean de Urgenta Tirgu Mures

Târgu Mureş, , Romania

Site Status

Territorial State Budgetary Healthcare Institution "Territorial Clinical Hospital"

Barnaul, , Russia

Site Status

State Budgetary Healthcare Institution, Chelyabinsk Regional Clinical Hospital

Chelyabinsk, , Russia

Site Status

FSBEI of HE "Kazan State Medical University" of Ministry of Healthcare of the Russia Federation, Department of hospital therapy

Kazan', , Russia

Site Status

Medical Center Maximum Zdorovia LLC

Kemerovo, , Russia

Site Status

Kemerovo State Medical University on the base of Regional Clinical Hospital for War Veterans

Kemerovo, , Russia

Site Status

Municipal Clinical Hospital No. 15 named after O.M. Filatov

Moscow, , Russia

Site Status

City Clinical Hospital #4 of Department of Healthcare of Moscow City

Moscow, , Russia

Site Status

M. Vladimirsky Moscow Regional Research Clinical Institute

Moscow, , Russia

Site Status

Municipal Clinical Hospital No. 40 Department of healthcare of Moscow City

Moscow, , Russia

Site Status

Nizhny Novgorod City Clinical Hospital #5

Nizhny Novgorod, , Russia

Site Status

Saint-Petersburg State Budgetary Healthcare Institution "Clinical rheumatology hospital # 25"

Saint Petersburg, , Russia

Site Status

LLC Polyclinic of Private Security Personnel

Saint Petersburg, , Russia

Site Status

State Healthcare Institution, Regional Clinical Hospital

Saratov, , Russia

Site Status

LLC BioMed

Vladimir, , Russia

Site Status

State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital for Emergency Medical Care n. a. N. V. Solovyev"

Yaroslavl, , Russia

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Institute Of Rheumatology

Belgrade, , Serbia

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Military Medical Academy, Clinic of Rheumatology

Belgrade, , Serbia

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Clinical Hospital Center Bezanijska Kosa

Belgrade, , Serbia

Site Status

Institute For Treatment And Rehabilitation Niska Banja

Niška Banja, , Serbia

Site Status

Neštátna Reumatologická Ambulancia

Bratislava, , Slovakia

Site Status

Reumex S.R.O.

Rimavská Sobota, , Slovakia

Site Status

LERAM s.r.o.

Topoľčany, , Slovakia

Site Status

Arthritis Clinical Trial Centre

Cape Town, , South Africa

Site Status

Netcare St. Augustine's Hospital

Durban, , South Africa

Site Status

Umhlanga Netcare Medical Centre

Durban, , South Africa

Site Status

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, , South Africa

Site Status

Winelands Medical Research Centre

Stellenbosch, , South Africa

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Pusan National University Hospital

Busan, , South Korea

Site Status

Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Daegu Catholic University Medical Center

Daegu, , South Korea

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Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Eulji University Hospital

Daejeon, , South Korea

Site Status

Chonnam National University Hospital

Gwangju, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Chonbuk National University Medical School

Jeonju, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Hanyang University Seoul Hospital

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Chung-Ang University Hospital Institutional Review Board

Seoul, , South Korea

Site Status

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Complejo Hospitalario Universitario de Santiago

A Coruña, , Spain

Site Status

Hospital Universitario Cruces

Barakaldo, , Spain

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Hospital General Universitario Gregorio Maranon

Madrid, , Spain

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Hospital Universitario Ramon y Cajal

Madrid, , Spain

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Hospital Regional Universitario de Malaga

Málaga, , Spain

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Corporacio Santiaria Parc Tauli

Sabadell, , Spain

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Clínica Gaias

Santiago de Compostela, , Spain

Site Status

Hospital HM Nuestra Senora de la Esperanza

Santiago de Compostela, , Spain

Site Status

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

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Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

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Chang Gung Memorial Hospital, Keelung

Keelung, , Taiwan

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Chung Shan Medical University Hospital

Taichung, , Taiwan

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Chi Mei Hospital, Chi Mei Medical Center

Tainan City, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

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Taipei Medical University Hospital

Taipei, , Taiwan

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Tri-Service General Hospital

Taipei, , Taiwan

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Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, , Taiwan

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Phramongkutklao Hospital, Division of Rheumatology, Department of Medicine

Bangkok, , Thailand

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Rajavithi Hospital, Rheumatology and Allergy Unit

Bangkok, , Thailand

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Faculty of Medicine Siriraj Hospital, Mahidol University, Division of Rheumatology, Department of Medicine

Bangkok, , Thailand

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Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

Chiang Mai, , Thailand

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Faculty of Medicine, Prince of Songkla University, Songklanagarind Hospital

Songkhla, , Thailand

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Municipal Institution Dnipropetrovsk 6th City Clinical Hospital of Dnipropetrovsk Regional Council

Dnipro, , Ukraine

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Municipal Nonprofit Enterprise of the Kharkiv Regional Council, Regional Hospital for War Veterans, Department of Therapy #1

Kharkiv, , Ukraine

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State Institution "National Institute of Therapy named after L.T. Maloyi" of National Academy of Medical Sciences of Ukraine"

Kharkiv, , Ukraine

Site Status

Municipal Institution of Heath Care "Regional Clinical Hospital-Center Of Emergency Medicine & Disaster Medicine"

Kharkiv, , Ukraine

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Municipal Nonprofit Enterprise "City Clinical Hospital #13" of the Kharkiv City Council, Department of Therapy

Kharkiv, , Ukraine

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Minicipal Institution "Kherson City Clinical Hospital n. a. Afanasiy and Olga Tropinykh", Department of Therapy #1

Kherson, , Ukraine

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Kyiv Oleksandrivska City Clinical Hospital, Department of Rheumatology # 2

Kyiv, , Ukraine

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Kyiv City Clinical Hospital #6, Department of Therapy

Kyiv, , Ukraine

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State Institution National Scientific Center M.D. Strazhesko Institute of Cardiology of NAMS of Ukraine

Kyiv, , Ukraine

Site Status

Municipal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital", Highly Specialized Therapeutic Department

Kyiv, , Ukraine

Site Status

Lutsk City Clinical Hospital

Lutsk, , Ukraine

Site Status

Municipal Institution of Lviv Regional Council "Lviv Regional Clinical Hospital" Department of Rheumatology

Lviv, , Ukraine

Site Status

Municipal Nonprofit Enterprise "4-th City Clinical Hospital in Lviv", Department of Rheumatology

Lviv, , Ukraine

Site Status

Municipal Institution Odesa Regional Clinical Hospital, Polyclinic Department

Odesa, , Ukraine

Site Status

Vinnytsya Regional Clinical Hospital named after M. I. Pyrogova, Department of Rheumatology

Vinnytsia, , Ukraine

Site Status

City Clinical Hospital #1, Department of Rheumatology

Vinnytsia, , Ukraine

Site Status

Medical Centre Modern Clinic, LLC

Zaporizhzhya, , Ukraine

Site Status

Municipal Institution "City Hospital #1", Department of Therapy

Zaporizhzhya, , Ukraine

Site Status

Municipal Institution City Hospital #7, Department of Therapy

Zaporizhzhya, , Ukraine

Site Status

NHS Lothian, Western General Hospital

Edinburgh, , United Kingdom

Site Status

Princess Alexandra Hospital

Harlow, , United Kingdom

Site Status

Northumbria Healthcare NHS Foundation Trust

North Shields, , United Kingdom

Site Status

Warrington and Halton Hospitals Nhs Foundation Trust

Warrington, , United Kingdom

Site Status

Countries

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

References

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Tanaka Y, Matsubara T, Atsumi T, Amano K, Ishiguro N, Hirata S, Yamaoka K, Combe BG, Nash P, Genovese M, Pechonkina A, Liu J, Kondo A, Fukada H, De Leonardis F, Takeuchi T. Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4. Mod Rheumatol. 2025 Apr 8;35(3):425-433. doi: 10.1093/mr/roae099.

Reference Type DERIVED
PMID: 39506562 (View on PubMed)

Balsa A, Wassenberg S, Tanaka Y, Tournadre A, Orzechowski HD, Rajendran V, Lendl U, Stiers PJ, Watson C, Caporali R, Galloway J, Verschueren P. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Dec;10(6):1555-1574. doi: 10.1007/s40744-023-00599-1. Epub 2023 Sep 25.

Reference Type DERIVED
PMID: 37747626 (View on PubMed)

Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.

Reference Type DERIVED
PMID: 36205910 (View on PubMed)

Other Identifiers

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2016-003630-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-417-0304

Identifier Type: -

Identifier Source: org_study_id

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