Trial Search Results
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
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.
Stanford is currently not accepting patients for this trial.
- Drug: GS-5718
- Drug: GS-5718
- Drug: Placebo to match GS-5718
- Drug: Tofacitinib 5 mg
- Drug: Placebo to match Tofacitinib
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.
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study