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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02065700
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Galapagos NV

Study Description
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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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Filgotinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 739 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2014
Actual Primary Completion Date : January 19, 2023
Actual Study Completion Date : January 19, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Filgotinib 200 mg once daily
Filgotinib 200 mg (2 x 100 mg) once daily (morning)
 Drug: Filgotinib
Tablets administered orally
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Filgotinib 100 mg twice daily
Filgotinib 100 mg twice daily (morning and evening)
 Drug: Filgotinib
Tablets administered orally
Other Names:
  • GS-6034
  • GLPG0634


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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) ]
  11. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065700


Locations
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Sponsors and Collaborators
Galapagos NV
Gilead Sciences
Investigators
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Study Director: Galapagos Study Director Galapagos NV
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT02065700    
Other Study ID Numbers: GLPG0634-CL-205
2012-003655-11 ( EudraCT Number )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galapagos NV:
Methotrexate
insufficient responders
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases