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.
We found this trial at
110
sites
32615 US Highway 19 North
Palm Harbor, Florida 34684
Palm Harbor, Florida 34684
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215 South Hickory Street
Escondido, California 92025
Escondido, California 92025
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4707 Papermill Drive Northwest
Knoxville, Tennessee 37909
Knoxville, Tennessee 37909
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1020 Medical Park Avenue
New Bern, North Carolina 28562
New Bern, North Carolina 28562
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Summerville, South Carolina 29486
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