A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Study Identifier
M14-663
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Japanese

Study Details

Medical Condition
  • Rheumatoid Arthritis
  • Study Drug
  • Placebo
  • Upadacitinib
  • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This is a randomized, double-blind study comparing ABT-494 to placebo in Japanese participants 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.

    Following marketing approval of upadacitinib for rheumatoid arthritis in Japan, this study will become a post-marketing clinical study and include a long-term extension period.

    Study Locations

    Location
    Status
    Location
    Nagoya University Hospital /ID# 148005
    Nagoya, Aichi-ken, Japan, 466-8560
    Status
    Not applicable
    Location
    Hamanomachi Hospital /ID# 147991
    Fukuoka, Fukuoka, Japan, 810-8539
    Status
    Not applicable
    Location
    Kyushu University Hospital /ID# 148008
    Fukuoka, Fukuoka, Japan, 812-8582
    Status
    Not applicable
    Location
    Inoue Hospital /ID# 147966
    Takasaki, Gunma, Japan, 3700053
    Status
    Not applicable
    Location
    National Hospital Organization Asahikawa Medical Center /ID# 147994
    Asahikawa, Hokkaido, Japan, 070-8644
    Status
    Not applicable
    Location
    Katayama Orthopedic Rheumatology Clinic /ID# 147976
    Asahikawa, Hokkaido, Japan, 078-8243
    Status
    Not applicable
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