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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 : June 30, 2020
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 19, 2017
Last Update Posted Date June 30, 2020
Actual Study Start Date  ICMJE February 28, 2017
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Proportion of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 6 years ]
  • Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 6 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
  • Proportion of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 3 years ]
  • Proportion of Participants Experiencing Clinically Significant Laboratory Abnormalities [ Time Frame: Up to 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm [ Time Frame: Up to 6 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
Proportion of Participants Achieving American College of Rheumatology- N (ACR-N) Response in Each Arm [ Time Frame: Up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
Official Title  ICMJE A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE RheumatoId Arthritis
Intervention  ICMJE
  • Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
    • GS-6034
    • GLPG0634
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily
Study Arms  ICMJE
  • Experimental: Blinded Phase: Filgotinib 200 mg
    Filgotinib 200 mg plus placebo to match (PTM) filgotinib 100 mg for up to 6 years
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
  • Experimental: Blinded Phase: Filgotinib 100 mg
    Filgotinib 100 mg plus PTM filgotinib 200 mg for up to 6 years
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
  • Experimental: Open Label Phase: Filgotinib 200 mg
    Filgotinib 200 mg for up to 6 years
    Intervention: Drug: Filgotinib
  • Experimental: Open Label Phase: Filgotinib 100 mg
    Filgotinib 100 mg for up to 6 years
    Intervention: Drug: Filgotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 16, 2019)
2731
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2017)
2800
Estimated Study Completion Date  ICMJE May 2025
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Belgium,   Bulgaria,   Canada,   Czechia,   France,   Germany,   Hong Kong,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Poland,   Romania,   Serbia,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03025308
Other Study ID Numbers  ICMJE GS-US-417-0304
2016-003630-25 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Galapagos NV
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP