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A Study Comparing an Active Drug to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

Brief summary

The primary objectives of this study are to compare the efficacy, safety, and tolerability of an active drug 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs

Interventional study

Status:
Active, not recruiting
Conditions:
Rheumatoid Arthritis
Enrollment:
661 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M13-549
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 99 Years.

Inclusion Criteria:

- Adult male or female, at least 18 years old.

- Diagnosis of Rheumatoid Arthritis (RA) for greater than or equal to 3 months.

- Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for
greater than or equal to 3 months and on a stable dose for greater than or equal to 4
weeks prior to the first dose of study drug. The following csDMARDs are allowed:
Methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.

- Meets the following minimum disease activity criteria: greater than or equal to 6
swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints
(based on 68 joint counts) at Screening and Baseline Visits.

- Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled
(up to 20% of study population) if they have documented evidence of intolerance to
bDMARDs or limited exposure (less than 3 months) and have satisfied required washout
periods.

Exclusion Criteria:

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

- History of inflammatory joint disease other than RA. History of secondary Sjogren's
Syndrome is permitted.

- Subjects who are considered inadequate responders to bDMARD therapy as determined by
the Investigator.

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