Rheumatoid Arthritis Clinical Trial
Official title:
Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX
The objective of this study was to verify the efficacy of ASP015K versus placebo administrated in combination with methotrexate (MTX) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to MTX
This study was a multi-center, randomized, placebo-controlled, double-blind, parallel-group,
confirmatory study to evaluate the efficacy and safety of ASP015K (100 and 150 mg/day)
administered in combination with MTX in participants with RA who had an inadequate response
to MTX.
Participants orally received ASP015K 100 mg, ASP015K 150 mg or placebo once daily (QD) in
combination with MTX after breakfast for 52 weeks.
At Week 12, inadequate responders in the placebo group, as determined by a < 20% improvement
from baseline (i.e., treatment initiation day) in tender or painful joint count (TJC) and
swollen joint count (SJC), were switched to either ASP015K 100 mg or ASP015K 150 mg, and the
dosage was maintained until the end of treatment (EOT). In addition, participants who
received placebo at Week 28 were switched to either ASP015K 100 mg or ASP015K 150 mg, and the
dosage was maintained until the EOT.
The ASP015K dose that was started for placebo group participants at Week 12 or Week 28 was
randomly chosen at baseline. The dose was switched under the blinded condition.
Participants who completed this study were eligible for participation in the open-label
extension study (015K-CL-RAJ2). Participants made a follow-up visit after the week 52 visit
if they did not enroll into the extension study on the day of the week 52 visit.
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