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

May 6, 2024 updated by: Galapagos NV

A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis

The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.

Participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
739

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Atencion Integral en Reumatologa
      • Buenos Aires, Argentina
        • CER Intituto Medico
      • Buenos Aires, Argentina
        • Organizacion Medica de Investigaciones (OMI)
      • Cordoba, Argentina
        • Instituto Reumatológico Strusberg
      • Lanus, Argentina
        • CIMeL Centro dee Investigacion Medico Lanus
      • Rosario, Argentina
        • Instituto Caici
      • San Fernando, Argentina
        • Instituto de Asistencia Reumatologia Integral - IARI
      • San Miguel de Tucumán, Argentina
        • Centro Medico Privado de Reumatologia
  • Australia
      • Woolloongabba, Australia
        • Princess Alexandra Hospital
    • Flinders Drive, South Australia
      • Bedford Park, Flinders Drive, South Australia, Australia
        • Flinders Medical Centre
    • Victoria
      • Clayton, Victoria, Australia
        • Monash Medical Centre
  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires St-Luc
      • Leuven, Belgium
        • UZ Leuven
  • Bulgaria
      • Plovdiv, Bulgaria
        • University "Multiprofile Hospital for Active Treatment - Kaspela" LTD
      • Ruse, Bulgaria
        • Multiprofile Hospital for Active Treatment - Ruse
      • Sofia, Bulgaria
        • Diagnostic Consultative Center "Sveta Anna" LTD
      • Sofia, Bulgaria
        • National Multiprofile Transport Hospital "Tsar Boris III," Sofia, Clinical of Internal Diseases
      • Sofia, Bulgaria
        • University Multiprofile Hospital for Active Treatment "SV. Ivan Rilski" EAD, Sofia, Rheumatology Clinic
  • Chile
      • Santiago, Chile
        • PROSALUD
      • Santiago, Chile
        • Hospital Regional "Guillermo Grant Benavente"
      • Santiago, Chile
        • Someal SA
      • Temuco, Chile
        • Centro de Investigacion Clinica del Sur
      • Temuco, Chile
        • Consulta Privada Dra. Ponce
  • Colombia
      • Barranquilla, Colombia
        • Circaribe S.A.S
      • Bogota, Colombia, 110221
        • Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
      • Bogota, Colombia
        • Idearg Sas
      • Bogotá, Colombia, 110221
        • Riesgo De Fractura Cayre Ips7
      • Cundinamarca, Colombia
        • Preventive Care SAS
      • Medellin, Colombia
        • Hospital Pablo Tobon Uribe
    • Santander
      • Bucaramanga, Santander, Colombia
        • Medicity S.A.S.
  • Czechia
      • Brno, Czechia
        • Revmatologie S.R.O
      • Kladno, Czechia
        • Revmatologicka a interni ambulance
      • Praha-Nusle, Czechia
        • Revmatologicka ambulance
      • Zlin, Czechia
        • PV-MEDICAL s.r.o.
  • France
      • Strasbourg CEDEX, France
        • Hospitaux de Hautepierre
  • Germany
      • Berlin, Germany
        • Schlossparkklinik - Akad. Lehrkrankenhaus Charite
      • Hamburg, Germany
        • MVZ Rheumatologie and Autoimmun Medizin HH GmbH
  • Guatemala
      • Guatemala, Guatemala
        • Clinica de Especialidades Medicas
      • Guatemala, Guatemala
        • Clinica Medica Especializada en Reumatologia
      • Guatemala, Guatemala
        • Clinica Medica
      • Guatemala, Guatemala
        • Reuma S.A.
      • Guatemala, Guatemala
        • Reuma-Centro
      • Guatemala City, Guatemala
        • Centro Clinico
  • Hungary
      • Balatonfured, Hungary
        • Gyogyszervizs galo Kozpont Kft
      • Budapest, Hungary
        • Qualiclinic Kft.
      • Budapest, Hungary
        • Reumatologiai Kft.
      • Eger, Hungary
        • Markhot Ferenc Hospital, Rheumatology
      • Veszprem, Hungary
        • Csolnoky Ferenc Hospital, Rheumatology
  • Israel
      • Haifa, Israel
        • Rambam Medical Center
      • Haifa, Israel
        • Carmel Medical Center
  • Latvia
      • Adazi, Latvia
        • Ltd M&M Centr
      • Baldone, Latvia
        • SIA Arijas Ancane's Family Doctor
      • Daugavpils, Latvia
        • Daugavpils Regional Hospital
      • Liepaja, Latvia
        • L. Atikes doktorats
      • Riga, Latvia
        • 'Bruninieku' polyclinic
  • Mexico
      • Ciudad de Mexico, Mexico
        • Centro Medico Dalinde
      • Guadalajara, Mexico
        • Centro de Estudios de Investigacion Basica y Clinica, Sc
      • Mexico, Mexico
        • ARKE Estudios Clínicos S.A. de C.V.
      • Mexico, Mexico
        • Clinstile, S.A. de C.V.
      • Mexico, Mexico
        • Hospital General De Mexico
      • Monterrey, Mexico
        • Hospital Universitario José E. Gonzalez
      • Oaxaca, Mexico
        • OSMO
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • IMSP Institutul de Cardiologie
  • New Zealand
      • Hamilton, New Zealand
        • Waikato Hospital
      • Timaru, New Zealand
        • Timaru Rheumatology Studies
  • Poland
      • Bialystok, Poland
        • NZOZ Osteo-Medic s.c.
      • Bytom, Poland
        • Centrum Medyczne Silesiana Sp. Z.o.o.
      • Katowice, Poland
        • Centrum Medyczne Pratia Katowice
      • Krakow, Poland
        • Centrum Medyczne Plejady
      • Krakow, Poland
        • NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
      • Krakow, Poland
        • Specjalistyczne Centrum Medyczne Nowomed
      • Skierniewice, Poland
        • NZOZ Przychodnia Lekarska "Eskulap"
      • Starachowice, Poland
        • Powiatowy Zaklad Opieki Zdrowotnej w Starachowicach
      • Torun, Poland
        • NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz
      • Warsaw, Poland
        • AMED Medical Center
      • Warszawa, Poland
        • Rheumatica Sp. Z.o.o.
  • Romania
      • Bucuresti, Romania
        • Spitalul Clinic Sfanta Maria
      • Galati, Romania
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati
  • Russian Federation
      • Moscow, Russian Federation
        • First Moscow State Medical University n.a. I.M. Sechenova of the Ministry of Health
      • Moscow, Russian Federation
        • Scientific Research Institute of Rheumatology
      • Nizhniy Novgorod, Russian Federation
        • City Clinical Hospital #5
      • Orenburg, Russian Federation
        • GBOU VPO Orenburg State Medical University
      • Ryazan, Russian Federation
        • Ryazan State Medical University
      • Saratov, Russian Federation
        • Regional Clinical Hospital
      • St Petersburg, Russian Federation
        • City Hospital #26
      • Vladimir, Russian Federation
        • Vladimir Regional State Instituion of Healthcare
  • Spain
      • A Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña (CHUAC)
      • A Coruña, Spain
        • Sanatorio Nuestra Señora de la Esperanza
      • Sabadell, Spain
        • Hospital Parc Tauli
  • Ukraine
      • Kharkiv, Ukraine
        • Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13
      • Kharkiv, Ukraine
        • Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology
      • Kharkiv, Ukraine
        • L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine
      • Kherson, Ukraine
        • Kherson City Clinical Hospital N. A. Afanasii and Olga Tropin
      • Kiev, Ukraine
        • Municipal Non-Profit Institution Consultative and Diagnostic Centre of Desnyasky District of Kyiv
      • Kyiv, Ukraine
        • Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kiev city
      • Vinnytsya, Ukraine
        • Vinnitsya Regional Clinical Hospital Named after M.I.Pirogov, Rheumatology Department
  • United States
    • Arizona
      • Gilbert, Arizona, United States
        • Arthro, Arthritis Care & Research
      • Mesa, Arizona, United States
        • Arizona Arthritis & Rheumatology Research PLLC
    • California
      • Hemet, California, United States
        • C.V. Mehta MD Medical Corp.
      • Palm Desert, California, United States
        • Desert Medical Advances
    • Florida
      • Boca Raton, Florida, United States
        • RASF Clinical Research Center
      • Ormond Beach, Florida, United States
        • Millenium Research
      • Venice, Florida, United States
        • Lovelace Scientific Resources
    • Illinois
      • Springfield, Illinois, United States
        • Springfield Clinic
    • Maryland
      • Hagerstown, Maryland, United States
        • Klein and Associates MD, PA
    • North Carolina
      • Greenville, North Carolina, United States
        • Physicians East
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Health Research of Oklahoma
    • South Carolina
      • Charleston, South Carolina, United States
        • Low County Rheumatology PA
    • Tennessee
      • Jackson, Tennessee, United States
        • West Tennessee Research Institute
    • Texas
      • Austin, Texas, United States
        • Austin Rheumatology Research PA
      • Houston, Texas, United States
        • Pioneer Research Solutions Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Filgotinib Darwin 1

Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 milligrams (mg) in this extension study, with the exception of male participants in the United States (US) who were limited to a daily dose of 100 mg due to a Food and Drug Administration (FDA) requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.

In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
Drug: Filgotinib
Administered as Oral Tablets
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Filgotinib Darwin 2

Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg once daily (q.d) in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.

Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
Drug: Filgotinib
Administered as Oral Tablets
Other Names:
  • GS-6034
  • GLPG0634

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame: From First dose to Week 437

An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date.
From First dose to Week 437

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408

The American College of Rheumatology (ACR) response was a measurement of improvement in multiple disease assessment criteria.

The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in swollen joint count 66 (SJC66), and 2) ≥ 20% improvement from baseline in tender joint count 68 (TJC68), and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2.Subject's Global Assessment of Disease Activity (SGA) (VAS), 3. Physician's Global Assessment of Disease Activity (PGA) (VAS), 4. Total HAQ-DI score, and 5. High-Sensitivity C- Reactive Protein (hsCRP).
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408

The ACR response was a measurement of improvement in multiple disease assessment criteria.

The ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP.
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Percentage of Participants Achieving ACR50 Response: NRI
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408

The ACR response was a measurement of improvement in multiple disease assessment criteria.

ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP.
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Percentage of Participants Achieving ACR50 Response: OC
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408

The ACR response was a measurement of improvement in multiple disease assessment criteria.

ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2.SGA (VAS) 3. PGA (VAS) 4. Total HAQ-DI score 5. hsCRP.
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Percentage of Participants Achieving ACR70 Response: NRI
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408

The ACR response was a measurement of improvement in multiple disease assessment criteria.

ACR70 response was defined as : 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP.
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Percentage of Participants Achieving ACR70 Response: OC
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408

The ACR response was a measurement of improvement in multiple disease assessment criteria.

ACR70 response was defined as : 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5.hsCRP.
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
ACR N% Improvement (ACR-N) Response: OC
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
ACR-N was defined as the smallest percentage improvement from core baseline in SJC66, TJC68 and the median of the following 5 items (Pain VAS [taken from the HAQ-DI], 2.SGA (VAS), 3. PGA (VAS), 4. Total HAQ-DI score, and 5. hsCRP). It had a range between 0 and 100%.
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
Time Frame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408

The DAS28(CRP) was a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), SGA [using a VAS on a scale of 0 (very well) to 100 (very poor)] and hsCRP using the formula:

DAS28(CRP) = 0.56 * Square root [SQRT] (TJC28) + 0.28 * SQRT(SJC28) + 0.36 * Ln(CRP+1) + 0.014 * SGA + 0.96

and the total possible score ranged from 1 to 9.4. Higher values indicated higher disease activity. A negative change from baseline indicated improvement.
Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
Time Frame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm), CRP (mg/dL). SDAI = TJC + SJC + SGA + PGA+ CRP. The SDAI score ranged from 0 to approximately 86. Higher SDAI indicated greater disease activity. A negative change from baseline indicated improvement.
Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
Time Frame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
The CDAI was the SDAI modified that excluded CRP and consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0 to 10 cm), PGA (0 to 10 cm). SDAI = TJC + SJC + SGA+ PGA. The CDAI score ranged from 0 to approximately 76. Higher CDAI indicated greater disease activity. A negative change from baseline indicated improvement.
Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
Time Frame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408

DAS28(CRP) was categorized into EULAR response categories (none, moderate, good) as follows:

None= Actual DAS28(CRP) ≤ 3.2, > 3.2 to ≤ 5.1, or > 5.1 AND Improvement in DAS28(CRP) from baseline ≤ 6.0 or > 0.6 to ≤ 1.2;

Moderate= Actual DAS28(CRP) ≤ 3.2 AND Improvement in DAS28(CRP) from baseline > 0.6 to ≤ 1.2, Actual DAS28(CRP) > 3.2 to ≤ 5.1 or > 5.1 AND Improvement in DAS28(CRP) from baseline > 1.2, or Actual DAS28(CRP) > 3.2 to ≤ 5.1 AND Improvement in DAS28(CRP) from baseline > 0.6 to ≤ 1.2;

Good= Actual DAS28(CRP) ≤ 3.2 AND Improvement in DAS28(CRP) from baseline > 1.2.
Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Percentage of Participants Achieving ACR/EULAR Remission: NRI
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1.
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Percentage of Participants Achieving ACR/EULAR Remission: OC
Time Frame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
A participant's disease activity status was defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and SGA (cm) were all ≤ 1.
Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
Time Frame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384

The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components:

  • Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items).
  • Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items).

These scales were from 0 to 100 with higher scores indicating a better quality of life.
Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
Time Frame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384

The health-related quality of life of the subject was assessed using the SF-36 with a 4-week recall period. This consists of 36 questions belonging to 8 domains in 2 components:

  • Physical well-being: 4 domains: physical functioning (10 items), role physical (4 items), bodily pain (2 items), and general health (GH) perceptions (5 items).
  • Mental well-being: 4 domains: vitality (4 items), social functioning (2 items), role emotional (3 items), and mental health (5 items).

These scales were from 0 to 100 with higher scores indicating a better quality of life.
Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
Time Frame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
FACIT-Fatigue scale was a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). Negatively stated items were reversed by subtracting the response from "4" before being added to obtain a total score. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating less fatigue. A positive change from baseline indicated better quality of life.
Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galapagos NV

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Galapagos Study Director, Galapagos NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2014

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLPG0634-CL-205
  • 2012-003655-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified external researchers may request IPD for clinical trials that support an approved indication in the EU and the US for which Galapagos is the Marketing Authorisation / New Drug Application Holder, with a marketing authorisation date on or after January 1, 2021 and for which the summary results have been published on ClinicalTrials.gov (CT.gov) and/or the EU Clinical Trials Register (EU CTR). For clinical trials of newly approved compounds or indications the IPD can be requested at earliest 6 months after the EMA and FDA approval. The study last patient last visit (LPLV) must have occurred at least 18 months prior to the request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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