A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 3/8/2019 |
Start Date: | December 17, 2015 |
End Date: | October 1, 2021 |
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
This is a multi center, randomized, double-blind, placebo-controlled phase 3 study in
subjects with moderately to severely active rheumatoid arthritis on a stable dose of csDMARDs
who have had an inadequate response to csDMARDs.
subjects with moderately to severely active rheumatoid arthritis on a stable dose of csDMARDs
who have had an inadequate response to csDMARDs.
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.
We found this trial at
58
sites
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Hendersonville, Tennessee 37075
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Summerville, South Carolina 29486
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