Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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).

Official Title

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

Keywords

RheumatoId Arthritis Arthritis Arthritis, Rheumatoid Filgotinib Filgotinib Dose A Filgotinib Dose B

Eligibility

For people ages 18 years and up

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.

Locations

  • University of California San Diego (UCSD) - Perlman Ambulatory Clinic
    La Jolla California 92037 United States
  • C.V. Mehta M.D. Medical Corporation
    Hemet California 92543 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03025308
Phase
Phase 3
Study Type
Interventional
Last Updated