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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Filgotinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Filgotinib 200 mg once daily<br>Filgotinib 200 mg (2 x 100 mg) once daily (morning) | Drug: Filgotinib<br>* Tablets administered orally<br>* Other names: GLPG0634;|
| Experimental: Filgotinib 100 mg twice daily<br>Filgotinib 100 mg twice daily (morning and evening) | Drug: Filgotinib<br>* Tablets administered orally<br>* Other names: GLPG0634;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Long-Term Dosing of Filgotinib as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Adverse Events |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving American College of Rheumatology (ACR)20 Response at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Percentage of Participants Achieving ACR50 Response at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Percentage of Participants Achieving ACR70 Response at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Percentage of Participants Achieving ACR-N Response at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Percentage of Participants Achieving ACR/EULAR Remission at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Percentage of Participants Achieving a Clinical Disease Activity Index (CDAI) Response at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Percentage of Participants Achieving a Simplified Disease Activity Index (SDAI) Response at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Percentage of Participants Achieving a Disease Activity Score Based on 28 Joints and C-Reactive Protein (DAS28-CRP) Response at Every Visit |  | Approximately 96 months, from Entry Visit to Final Visit (last dose), every 12 weeks | 
| Quality of Life: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Every 48 Weeks |  | Baseline to approximately 96 months, every 48 weeks until Final Visit (last dose) | 
| Quality of Life: Change from Baseline in the 36-Item Short Form Health Survey (SF-36) Score every 48 Weeks |  | Baseline to approximately 96 months, every 48 weeks until Final Visit (last dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methotrexate, insufficient responders