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

Trial ID or NCT#

NCT05165771

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-5718 on Background Therapy With Conventional Synthetic Disease-modifying Antirheumatic Drug(s) (csDMARDs) in Participants With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
View All Criteria
Show Less

Investigator(s)

Matthew C. Baker, MD MS
Matthew C. Baker, MD MS
Immunologist, Rheumatologist
Assistant Professor of Medicine (Immunology and Rheumatology)

View on ClinicalTrials.gov