A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
Study Identifier
M13-542
CT.gov Identifier
EudraCT Identifier
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, German, Hungarian, Polish, Spanish, Turkish
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18 - 99 Years
Protocol Summary
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.
Study Locations
Location
Status
Location
Rheum Assoc of North Alabama /ID# 145959
Huntsville, Alabama, United States, 35801
Status
Not applicable
Location
AZ Arthritis and Rheum Assoc /ID# 148593
Mesa, Arizona, United States, 85202
Status
Not applicable
Location
AZ Arthritis and Rheum Researc /ID# 142816
Phoenix, Arizona, United States, 85032-9306
Status
Not applicable
Location
AZ Arthritis and Rheum Researc /ID# 146075
Phoenix, Arizona, United States, 85032-9306
Status
Not applicable
Location
AZ Arthritis and Rheum Researc /ID# 148592
Phoenix, Arizona, United States, 85032-9306
Status
Not applicable
Location
Arizona Research Center, Inc. /ID# 142741
Phoenix, Arizona, United States, 85053-4061
Status
Not applicable
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