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

NCT03025308

CompletedPhase 3

Sponsor: Alfasigma S.p.A.

Conditions: Rheumatoid Arthritis

Interventions: Filgotinib, Placebo to match filgotinib

Countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Czechia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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)
* 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 (345)
  • Huntsville, Alabama, United States
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Covina, California, United States
  • Hemet, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Palm Desert, California, United States
  • Palo Alto, California, United States
  • Riverside, California, United States
  • Upland, California, United States
  • Victorville, California, United States
  • Whittier, California, United States
  • Aventura, Florida, United States
  • Clearwater, Florida, United States
  • DeBary, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • New Port Richey, Florida, United States
  • Orlando, Florida, United States
  • Plantation, Florida, United States
  • Decatur, Georgia, United States
  • Springfield, Illinois, United States
  • Kansas City, Kansas, United States
  • Wichita, Kansas, United States
  • Elizabethtown, Kentucky, United States
  • Lexington, Kentucky, United States
  • Cumberland, Maryland, United States
  • + 315 more on CT.gov