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
Study Drug
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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