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)
    La Jolla California 92037 United States
  • C.V.Mehta MD Medical Corporation
    Riverside California 92518 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03025308
Phase
Phase 3
Study Type
Interventional
Last Updated
September 20, 2018