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Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis (FINCH 4)

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: NCT03025308
Recruitment Status : Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : October 27, 2021
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Galapagos NV

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Filgotinib Drug: Placebo to match filgotinib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2731 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: This study was originally designed and initiated as a double-blind study but the study design will change to open-label following implementation of the protocol amendment # 4.
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Blinded Phase: Filgotinib 200 mg
Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
 Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Experimental: Blinded Phase: Filgotinib 100 mg
Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
 Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Experimental: Open Label Phase: Filgotinib 200 mg
Filgotinib 200 mg for up to 6 years
 Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Open Label Phase: Filgotinib 100 mg
Filgotinib 100 mg for up to 6 years
 Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 6 years ]
  2. Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 6 years ]

Secondary Outcome Measures :
  1. Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm [ Time Frame: Up to 6 years ]

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:

  • 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)
  • Males and 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.

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): NCT03025308


Locations
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Sponsors and Collaborators
Galapagos NV
Gilead Sciences
Investigators
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Study Director: Galapagos Study Director Gilead Sciences
More Information
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03025308    
Other Study ID Numbers: GS-US-417-0304
2016-003630-25 ( EudraCT Number )
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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