Clinical trial NCT03025308: Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
Official title: A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Alfasigma S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2017-01-19
Enrollment: 2731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

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