NCT03682705
Brief summary
This is a phase 2 study to evaluate safety and efficacy of a combination of active drugs vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDS) for the treatment of signs and symptoms of Rheumatoid Arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs(bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months based on the 2010 American
College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification
criteria for RA
- Participant meets the following minimum disease activity criteria:
- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68
joint counts) at Screening and Baseline Visits
- High-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L (central lab) at Screening
Visit
- Participants must have been treated for ≥ 3 months with ≥ 1 biologic disease-modifying
anti-rheumatic drug (bDMARD) therapy but continue to exhibit active RA or had to
discontinue due to intolerability or toxicity, irrespective of treatment duration
- Participants must have been receiving conventional synthetic disease-modifying
anti-rheumatic drug (csDMARD) therapy ≥ 3 months and on a stable dose for ≥ 4 weeks
prior to the first dose of study drug
- Participants must have discontinued all bDMARDs prior to the first dose of study drug
Exclusion Criteria:
- Participant has prior exposure to any Janus Kinase (JAK) inhibitor for greater than 2
weeks (including but not limited to upadacitinib, tofacitinib, baricitinib, and
filgotinib). A washout period of ≥ 30 days is required for any JAK inhibitor prior to the
first dose of study drug.
