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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.

Stanford Investigator(s):

Intervention(s):

  • drug: GS-5718
  • drug: GS-5718
  • drug: Placebo to match GS-5718
  • drug: Tofacitinib 5 mg
  • drug: Placebo to match Tofacitinib

Eligibility


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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting