A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 99
Updated:2/20/2019
Start Date:March 15, 2016
End Date:September 16, 2021

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A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

The comparison of safety and efficacy of two doses of Upadacitinib (ABT-494) versus placebo
in participants with rheumatoid arthritis on a stable background conventional synthetic
Disease Modifying Anti-Rheumatic Drug (csDMARD).


Inclusion Criteria:

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

- Subjects have been 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.

- Subjects have 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 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.

Exclusion Criteria:

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

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