A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | December 1, 2015 |
| End Date: | May 20, 2022 |
A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
This is a phase 3, randomized, double-blind study comparing ABT-494 to Placebo and to
Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a
stable background of Methotrexate (MTX) and who have an inadequate response to MTX.
Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a
stable background of Methotrexate (MTX) and who have an inadequate response to MTX.
Inclusion Criteria:
- Adult male or female, at least 18 years old.
- Diagnosis of RA for greater than or equal to 3 months.
- Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than
or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25
mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses
greater than or equal to 12.5 mg/week) for greater than or equal to 4 weeks prior to
the first dose of study drug. In addition all subjects should take a dietary
supplement of folic acid or folinic acid throughout the study participation.
- 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.
- At least one of the following at Screening: greater than or equal to 3 bone erosions
on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor
OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated
peptide autoantibodies.
- Subjects with prior exposure to only one Biological disease-modifying anti-rheumatic
drugs (bDMARD) (except ADA) may be enrolled (up to 20% of total study population) if
they have documented evidence of intolerance to the bDMARD or limited exposure (less
than 3 months), but required washout periods need to be satisfied.
- Except for MTX, subject must have discontinued all conventional synthetic
disease-modifying anti-rheumatic drugs (csDMARDs).
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
tofacitinib, baricitinib, and filgotinib).
- Subjects who have been exposed to adalimumab or who are considered inadequate
responders to bDMARD therapy as determined by the Investigator.
- History of inflammatory joint disease other than RA. History of secondary Sjogren's
Syndrome is permitted.
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