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Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03025308•Alfasigma S.p.A.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (345)

Rheumatology Associates of North Alabama, PC

Huntsville, Alabama, United States

Arthrocare, Arthritis Care & Research PC

Gilbert, Arizona, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Tucson, Arizona, United States

Medvin Clinical Research

Covina, California, United States

C.V. Mehta M.D. Medical Corporation

Hemet, California, United States

University of California San Diego (UCSD) - Perlman Ambulatory Clinic

La Jolla, California, United States

Keck Medicine of USC- Division of Rheumatology

Los Angeles, California, United States

Desert Medical Advances

Palm Desert, California, United States

Stanford University Hospitals and Clinics (Immunology & Rheumatology)

Palo Alto, California, United States

Key Dates

Start Date

February 28, 2017

Primary Completion Date

May 16, 2025

Completion Date

May 16, 2025

Last Updated

July 3, 2025

Enrollment

2,731

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

Filgotinib

DRUG

Placebo to match filgotinib

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Plant-Based Diet for Patients With Rheumatoid Arthritis

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An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis