Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-modifying Antirheumatic Drug(s) (bDMARDs) Treatment

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the effect of GS-5718 versus placebo for the treatment of rheumatoid arthritis (RA) as measured by change from baseline in Disease Activity Score (DAS) based on 28 joints using C-reactive protein (CRP) (DAS28[CRP]) at Week 12.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tofacitinib

Criteria

Key Inclusion Criteria:

• Diagnosis of rheumatoid arthritis (RA) ≥ 3 months prior to screening fulfilling the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA

• Rheumatoid factor (RF) and/or anti-citrullinated protein antibodies (ACPA) positivity

• Individual fulfills all of the following minimum disease activity criteria:

• ≥ 6 swollen joints (from a swollen joint count based on 66 joints [SJC66]) provided this would also fulfill ≥ 4 swollen joints (from a swollen joint count based on 28 joints [SJC28]) at screening and Day 1, and

• ≥ 6 tender joints (from a tender joint count based on 68 joints [TJC68]), provided this would also fulfill ≥ 4 tender joints (from a tender joint count based on 28 joints [TJC28]) at screening and Day 1, and

• hsCRP > upper limit of normal at screening

• Received at least one bDMARD for the treatment of RA to which there is a lack of efficacy and/or intolerance.

Key Exclusion Criteria:

• Individuals who do not qualify per the tofacitinib label and/or local guidelines should not be enrolled.

• Prior exposure to any Janus kinase inhibitor

Note: Other protocol defined Inclusion/Exclusion criteria may apply.