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Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients (DARWIN3)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Filgotinib
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Methotrexate, insufficient responders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male or female who are 18 years of age or older on the day of signing informed consent
  • Participants who completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the Investigator's judgment
  • Females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib

Key Exclusion Criteria:

  • Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason
  • Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), according to the Investigator's judgment
  • Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary Sjogren's syndrome
  • Any condition or circumstances which, in the opinion of the Investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Arthro, Arthritis Care & Research
  • Arizona Arthritis & Rheumatology Research PLLC
  • C.V. Mehta MD Medical Corp.
  • Desert Medical Advances
  • RASF Clinical Research Center
  • Millenium Research
  • Lovelace Scientific Resources
  • Springfield Clinic
  • Klein and Associates MD, PA
  • Physicians East
  • Health Research of Oklahoma
  • Low County Rheumatology PA
  • West Tennessee Research Institute
  • Austin Rheumatology Research PA
  • Pioneer Research Solutions Inc
  • Atencion Integral en Reumatologa
  • CER Intituto Medico
  • Organizacion Medica de Investigaciones (OMI)
  • Instituto Reumatologico Strusberg
  • CIMeL Centro dee Investigacion Medico Lanus
  • Instituto CAICI
  • Instituto de Asistencia Reumatologia Integral - IARI
  • Centro Médico Privado de Reumatologia
  • Monash Medical Centre
  • Repatriation General Hospital
  • Princess Alexandra Hospital
  • Cliniques Universitaires St-Luc
  • UZ Leuven
  • "Multiprofile Hospital for Active Treatment - Kaspela" LTD
  • University "Multiprofile Hospital for Active Treatment - Kaspela" LTD
  • Multiprofile Hospital for Active Treatment - Ruse
  • Diagnostic Consultative Center "Sveta Anna" LTD
  • National Multiprofile Transport Hospital "Tsar Boris III," Sofia, Clinical of Internal Diseases
  • University Multiprofile Hospital for Active Treatment "SV. Ivan Rilski" EAD, Sofia, Rheumatology Clinic
  • Hospital Regional "Guillermo Grant Benavente"
  • Prosalud
  • Someal SA
  • Centro de Investigacion Clinica del Sur
  • Consulta Privada Dra. Ponce
  • Medicity S.A.S.
  • Circaribe S.A.S
  • Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
  • Idearg Sas
  • Riesgo De Fractura Cayre Ips7
  • Preventive Care SAS
  • Hospital Pablo Tobon Uribe
  • Revmatologie S.R.O
  • Revmatologicka a interni ambulance
  • Revmatologicka ambulance
  • PV-Medical S.R.O.
  • Hospitaux de Hautepierre
  • Schlossparkklinik - Akad. Lehrkrankenhaus Charite
  • MVZ Rheumatologie and Autoimmun Medizin HH GmbH
  • Centro Clinico
  • Clinica de Especialidades Medicas
  • Clinica Medica Especializada en Reumatologia
  • Clinica Medica
  • Reuma S.A.
  • Reuma-Centro
  • Gyogyszervizs galo Kozpont Kft
  • QualiClinic Kft.
  • Reumatologiai Kft.
  • Markhot Ferenc Hospital, Rheumatology
  • Csolnoky Ferenc Hospital, Rheumatology
  • Carmel Medical Center
  • Rambam Medical Center
  • Ltd M&M Centr
  • SIA Arijas Ancane's Family Doctor
  • Daugavpils Regional Hospital
  • L. Atikes doktorats
  • 'Bruninieku' polyclinic
  • Centro Medico Dalinde
  • Centro de Estudios de Investigacion Basica y Clinica, SC
  • Arke Estudios Clinicos S.A. de C.V.
  • Clinstile, S.A. de C.V.
  • Hospital General de México
  • Hospital Universitario José E. Gonzalez
  • OSMO
  • IMSP Institutul de Cardiologie
  • Waikato Hospital
  • Timaru Rheumatology Studies
  • NZOZ Osteo-Medic s.c.
  • Centrum Medyczne Silesian a Sp. Z.o.o.
  • Centrum Medyczne Pratia Katowice la
  • Centrum Medyczne Plejady
  • NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
  • Specjalisty Czne Centrum Medyczne Nowomed
  • NZOZ Przychodnia Lekarska "Eskulap"
  • Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
  • NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz
  • AMED Medical Center
  • Ars Rheumatica Sp. Z.o.o.
  • Spitalul Clinic Sfanta Maria
  • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati
  • First Moscow State Medical University n.a. I.M. Sechenova of the Ministry of Health
  • Scientific Research Institute of Rheumatology
  • City Clinical Hospital #5
  • GBOU VPO Orenburg State Medical University
  • Ryazan State Medical University
  • Regional Clinical Hospital
  • City Hospital #26
  • Vladimir Regional State Instituion of Healthcare
  • Complejo Hospitalario Universitario A Coruña (CHUAC)
  • Sanatorio Nuestra Señora de la Esperanza
  • Hospital Parc Tauli
  • Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13
  • Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology
  • L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine
  • Kherson City Clinical Hospital N. A. Afanasii and Olga Tropin
  • Municipal Non-Profit Institution Consultative and Diagnostic Centre of Desnyasky District of Kyiv
  • Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kiev city
  • Vinnitsya Regional Clinical Hospital Named after M.I.Pirogov, Rheumatology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Filgotinib 200 mg once daily

Filgotinib 100 mg twice daily

Arm Description

Filgotinib 200 mg (2 x 100 mg) once daily (morning)

Filgotinib 100 mg twice daily (morning and evening)

Outcomes

Primary Outcome Measures

Safety and Tolerability of Long-Term Dosing of Filgotinib as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Adverse Events

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology (ACR)20 Response at Every Visit
Percentage of Participants Achieving ACR50 Response at Every Visit
Percentage of Participants Achieving ACR70 Response at Every Visit
Percentage of Participants Achieving ACR-N Response at Every Visit
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response at Every Visit
Percentage of Participants Achieving ACR/EULAR Remission at Every Visit
Percentage of Participants Achieving a Clinical Disease Activity Index (CDAI) Response at Every Visit
Percentage of Participants Achieving a Simplified Disease Activity Index (SDAI) Response at Every Visit
Percentage of Participants Achieving a Disease Activity Score Based on 28 Joints and C-Reactive Protein (DAS28-CRP) Response at Every Visit
Quality of Life: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Every 48 Weeks
Quality of Life: Change from Baseline in the 36-Item Short Form Health Survey (SF-36) Score every 48 Weeks

Full Information

First Posted
February 14, 2014
Last Updated
February 6, 2023
Sponsor
Galapagos NV
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02065700
Brief Title
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients
Acronym
DARWIN3
Official Title
A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 25, 2014 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis. Participants will be enrolled in this open-label long-term follow-up study after they have completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) or GLPG0634-CL-204 (DARWIN2), and will be evaluated for any side effects that may occur (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants will also be examined for long-term effects of filgotinib administration on disease activity (efficacy), subjects' disability, fatigue, and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Methotrexate, insufficient responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
739 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filgotinib 200 mg once daily
Arm Type
Experimental
Arm Description
Filgotinib 200 mg (2 x 100 mg) once daily (morning)
Arm Title
Filgotinib 100 mg twice daily
Arm Type
Experimental
Arm Description
Filgotinib 100 mg twice daily (morning and evening)
Intervention Type
Drug
Intervention Name(s)
Filgotinib
Other Intervention Name(s)
GS-6034, GLPG0634
Intervention Description
Tablets administered orally
Primary Outcome Measure Information:
Title
Safety and Tolerability of Long-Term Dosing of Filgotinib as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame
Approximately 96 months, from Entry Visit (last visit from the previous core study, GLPG0634-CL-203 or GLPG0634-CL-204) to Final Visit (last dose) plus 2 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology (ACR)20 Response at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Percentage of Participants Achieving ACR50 Response at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Percentage of Participants Achieving ACR70 Response at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Percentage of Participants Achieving ACR-N Response at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Percentage of Participants Achieving ACR/EULAR Remission at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Percentage of Participants Achieving a Clinical Disease Activity Index (CDAI) Response at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Percentage of Participants Achieving a Simplified Disease Activity Index (SDAI) Response at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Percentage of Participants Achieving a Disease Activity Score Based on 28 Joints and C-Reactive Protein (DAS28-CRP) Response at Every Visit
Time Frame
Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks
Title
Quality of Life: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Every 48 Weeks
Time Frame
Baseline to approximately 96 months, every 48 weeks until Final Visit (last dose)
Title
Quality of Life: Change from Baseline in the 36-Item Short Form Health Survey (SF-36) Score every 48 Weeks
Time Frame
Baseline to approximately 96 months, every 48 weeks until Final Visit (last dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female who are 18 years of age or older on the day of signing informed consent Participants who completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the Investigator's judgment Females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib Key Exclusion Criteria: Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), according to the Investigator's judgment Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary Sjogren's syndrome Any condition or circumstances which, in the opinion of the Investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galapagos Study Director
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
Arthro, Arthritis Care & Research
City
Gilbert
State/Province
Arizona
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
C.V. Mehta MD Medical Corp.
City
Hemet
State/Province
California
Country
United States
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
Country
United States
Facility Name
RASF Clinical Research Center
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Millenium Research
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Lovelace Scientific Resources
City
Venice
State/Province
Florida
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Klein and Associates MD, PA
City
Hagerstown
State/Province
Maryland
Country
United States
Facility Name
Physicians East
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Low County Rheumatology PA
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
Austin Rheumatology Research PA
City
Austin
State/Province
Texas
Country
United States
Facility Name
Pioneer Research Solutions Inc
City
Houston
State/Province
Texas
Country
United States
Facility Name
Atencion Integral en Reumatologa
City
Buenos Aires
Country
Argentina
Facility Name
CER Intituto Medico
City
Buenos Aires
Country
Argentina
Facility Name
Organizacion Medica de Investigaciones (OMI)
City
Buenos Aires
Country
Argentina
Facility Name
Instituto Reumatologico Strusberg
City
Cordoba
Country
Argentina
Facility Name
CIMeL Centro dee Investigacion Medico Lanus
City
Lanus
Country
Argentina
Facility Name
Instituto CAICI
City
Rosario
Country
Argentina
Facility Name
Instituto de Asistencia Reumatologia Integral - IARI
City
San Fernando
Country
Argentina
Facility Name
Centro Médico Privado de Reumatologia
City
San Miguel de Tucumán
Country
Argentina
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
Repatriation General Hospital
City
Daw Park
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Brussels
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
"Multiprofile Hospital for Active Treatment - Kaspela" LTD
City
Plovdiv
Country
Bulgaria
Facility Name
University "Multiprofile Hospital for Active Treatment - Kaspela" LTD
City
Plovdiv
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Ruse
City
Ruse
Country
Bulgaria
Facility Name
Diagnostic Consultative Center "Sveta Anna" LTD
City
Sofia
Country
Bulgaria
Facility Name
National Multiprofile Transport Hospital "Tsar Boris III," Sofia, Clinical of Internal Diseases
City
Sofia
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "SV. Ivan Rilski" EAD, Sofia, Rheumatology Clinic
City
Sofia
Country
Bulgaria
Facility Name
Hospital Regional "Guillermo Grant Benavente"
City
Santiago
Country
Chile
Facility Name
Prosalud
City
Santiago
Country
Chile
Facility Name
Someal SA
City
Santiago
Country
Chile
Facility Name
Centro de Investigacion Clinica del Sur
City
Temuco
Country
Chile
Facility Name
Consulta Privada Dra. Ponce
City
Temuco
Country
Chile
Facility Name
Medicity S.A.S.
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Circaribe S.A.S
City
Barranquilla
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Idearg Sas
City
Bogota
Country
Colombia
Facility Name
Riesgo De Fractura Cayre Ips7
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Preventive Care SAS
City
Cundinamarca
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
Country
Colombia
Facility Name
Revmatologie S.R.O
City
Brno
Country
Czechia
Facility Name
Revmatologicka a interni ambulance
City
Kladno
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Praha-Nusle
Country
Czechia
Facility Name
PV-Medical S.R.O.
City
Zlin
Country
Czechia
Facility Name
Hospitaux de Hautepierre
City
Strasbourg CEDEX
Country
France
Facility Name
Schlossparkklinik - Akad. Lehrkrankenhaus Charite
City
Berlin
Country
Germany
Facility Name
MVZ Rheumatologie and Autoimmun Medizin HH GmbH
City
Hamburg
Country
Germany
Facility Name
Centro Clinico
City
Guatemala City
Country
Guatemala
Facility Name
Clinica de Especialidades Medicas
City
Guatemala
Country
Guatemala
Facility Name
Clinica Medica Especializada en Reumatologia
City
Guatemala
Country
Guatemala
Facility Name
Clinica Medica
City
Guatemala
Country
Guatemala
Facility Name
Reuma S.A.
City
Guatemala
Country
Guatemala
Facility Name
Reuma-Centro
City
Guatemala
Country
Guatemala
Facility Name
Gyogyszervizs galo Kozpont Kft
City
Balatonfured
Country
Hungary
Facility Name
QualiClinic Kft.
City
Budapest
Country
Hungary
Facility Name
Reumatologiai Kft.
City
Budapest
Country
Hungary
Facility Name
Markhot Ferenc Hospital, Rheumatology
City
Eger
Country
Hungary
Facility Name
Csolnoky Ferenc Hospital, Rheumatology
City
Veszprem
Country
Hungary
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Ltd M&M Centr
City
Adazi
Country
Latvia
Facility Name
SIA Arijas Ancane's Family Doctor
City
Baldone
Country
Latvia
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
Country
Latvia
Facility Name
L. Atikes doktorats
City
Liepaja
Country
Latvia
Facility Name
'Bruninieku' polyclinic
City
Riga
Country
Latvia
Facility Name
Centro Medico Dalinde
City
Ciudad de México
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Basica y Clinica, SC
City
Guadalajara
Country
Mexico
Facility Name
Arke Estudios Clinicos S.A. de C.V.
City
Mexico
Country
Mexico
Facility Name
Clinstile, S.A. de C.V.
City
Mexico
Country
Mexico
Facility Name
Hospital General de México
City
Mexico
Country
Mexico
Facility Name
Hospital Universitario José E. Gonzalez
City
Monterrey
Country
Mexico
Facility Name
OSMO
City
Oaxaca
Country
Mexico
Facility Name
IMSP Institutul de Cardiologie
City
Chisinau
Country
Moldova, Republic of
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Timaru Rheumatology Studies
City
Timaru
Country
New Zealand
Facility Name
NZOZ Osteo-Medic s.c.
City
Bialystok
Country
Poland
Facility Name
Centrum Medyczne Silesian a Sp. Z.o.o.
City
Bytom
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice la
City
Katowice
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Krakow
Country
Poland
Facility Name
NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
City
Krakow
Country
Poland
Facility Name
Specjalisty Czne Centrum Medyczne Nowomed
City
Krakow
Country
Poland
Facility Name
NZOZ Przychodnia Lekarska "Eskulap"
City
Skierniewice
Country
Poland
Facility Name
Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
City
Starachowice
Country
Poland
Facility Name
NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz
City
Torun
Country
Poland
Facility Name
AMED Medical Center
City
Warsaw
Country
Poland
Facility Name
Ars Rheumatica Sp. Z.o.o.
City
Warszawa
Country
Poland
Facility Name
Spitalul Clinic Sfanta Maria
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati
City
Galati
Country
Romania
Facility Name
First Moscow State Medical University n.a. I.M. Sechenova of the Ministry of Health
City
Moscow
Country
Russian Federation
Facility Name
Scientific Research Institute of Rheumatology
City
Moscow
Country
Russian Federation
Facility Name
City Clinical Hospital #5
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
GBOU VPO Orenburg State Medical University
City
Orenburg
Country
Russian Federation
Facility Name
Ryazan State Medical University
City
Ryazan
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Saratov
Country
Russian Federation
Facility Name
City Hospital #26
City
St Petersburg
Country
Russian Federation
Facility Name
Vladimir Regional State Instituion of Healthcare
City
Vladimir
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC)
City
A Coruña
Country
Spain
Facility Name
Sanatorio Nuestra Señora de la Esperanza
City
A Coruña
Country
Spain
Facility Name
Hospital Parc Tauli
City
Sabadell
Country
Spain
Facility Name
Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13
City
Kharkiv
Country
Ukraine
Facility Name
Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology
City
Kharkiv
Country
Ukraine
Facility Name
L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine
City
Kharkiv
Country
Ukraine
Facility Name
Kherson City Clinical Hospital N. A. Afanasii and Olga Tropin
City
Kherson
Country
Ukraine
Facility Name
Municipal Non-Profit Institution Consultative and Diagnostic Centre of Desnyasky District of Kyiv
City
Kiev
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kiev city
City
Kyiv
Country
Ukraine
Facility Name
Vinnitsya Regional Clinical Hospital Named after M.I.Pirogov, Rheumatology Department
City
Vinnytsya
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36205910
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.
Results Reference
derived
PubMed Identifier
33526618
Citation
Kavanaugh A, Westhovens RR, Winthrop KL, Lee SJ, Tan Y, An D, Ye L, Sundy JS, Besuyen R, Meuleners L, Stanislavchuk M, Spindler AJ, Greenwald M, Alten R, Genovese MC. Safety and Efficacy of Filgotinib: Up to 4-year Results From an Open-label Extension Study of Phase II Rheumatoid Arthritis Programs. J Rheumatol. 2021 Aug;48(8):1230-1238. doi: 10.3899/jrheum.201183. Epub 2021 Feb 1.
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Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients

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