A Study to Compare an Active Drug to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

Brief summary

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of 30 mg once daily (QD) and 15 mg QD an active drug versus placebo for the treatment of signs and symptoms of participants with moderately to severely active RA who were on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

The study objective of Period 2 (Week 24 to Week 240) is to evaluate the long-term safety, tolerability, and efficacy of an active drug 30 mg QD and 15 mg QD in participants with RA who completed Period 1.

Interventional study

Rheumatoid Arthritis
499 patients
  • 1
  • 2
  • 3
  • 4
Protocol ID:
Intervention model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Eligibility criteria

Participant attributes:
Male and Female


From 18 Years to 99 Years.

Inclusion Criteria:

- Diagnosis of rheumatoid arthritis (RA) for≥ 3 months.

- Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or
had to discontinue due to intolerability or toxicity, irrespective of treatment
duration prior to the first dose of study drug.

- Participant has been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4
weeks prior to the first dose of study drug. The following csDMARDs are allowed:
methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A
combination of up to two background csDMARDs is allowed except the combination of MTX
and leflunomide.

- Meets both of the following criteria:

- ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint
counts) at Screening and Baseline Visits.

- hsCRP ≥ 3mg/L at Screening Visit.

Exclusion Criteria:

- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).

- History of any arthritis with onset prior to age 17 years or current diagnosis of
inflammatory joint disease other than RA (including but not limited to gout, systemic
lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing
spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap
connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia
[currently with active symptoms]). Current diagnosis of secondary Sjogren's Syndrome
is permitted.

All the cities where the clinical studies are located

Winnipeg - R3N 0K6


More information about this study