Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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).

Official Title
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A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Filgotinib
* Drug: Placebo to match filgotinib


Participation Criteria
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Eligibility Criteria
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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.

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: Blinded Phase: Filgotinib 200 mg<br>Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years | Drug: Filgotinib<br>* Tablet(s) administered orally once daily<br>* Other names: GLPG0634;Drug: Placebo to match filgotinib<br>* Tablet(s) administered orally once daily<br>|
| Experimental: Blinded Phase: Filgotinib 100 mg<br>Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years | Drug: Filgotinib<br>* Tablet(s) administered orally once daily<br>* Other names: GLPG0634;Drug: Placebo to match filgotinib<br>* Tablet(s) administered orally once daily<br>|
| Experimental: Open Label Phase: Filgotinib 200 mg<br>Filgotinib 200 mg for up to 6 years | Drug: Filgotinib<br>* Tablet(s) administered orally once daily<br>* Other names: GLPG0634;|
| Experimental: Open Label Phase: Filgotinib 100 mg<br>Filgotinib 100 mg for up to 6 years | Drug: Filgotinib<br>* Tablet(s) administered orally once daily<br>* Other names: GLPG0634;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Experiencing Adverse Events (AEs) |  | Up to 6 years | 
| Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities |  | Up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm |  | Up to 6 years |