A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 3/8/2019 |
Start Date: | March 2, 2016 |
End Date: | February 27, 2022 |
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
This is a randomized, double-blind study comparing Upadacitinib (ABT-494) monotherapy to
Methotrexate (MTX) monotherapy in subjects with moderately to severely active rheumatoid
arthritis who have had an inadequate response to methotrexate treatment.
Methotrexate (MTX) monotherapy in subjects with moderately to severely active rheumatoid
arthritis who have had an inadequate response to methotrexate treatment.
Inclusion Criteria:
- Diagnosis of RA for >= 3 months.
- Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable
dose for >= 4 weeks prior to first dose of study drug.
- Must have discontinued all conventional synthetic disease-modifying anti-rheumatic
drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.
- 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.
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).
- Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
- Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of
secondary Sjogren's Syndrome is permitted.
We found this trial at
53
sites
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1020 Medical Park Avenue
New Bern, North Carolina 28562
New Bern, North Carolina 28562
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