A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
Study Identifier
M15-925
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
For general inquiries, please contact
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, Spanish (Argentina), Spanish (Mexico), Dutch, Portuguese (Brazil), Turkish
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+ years
Protocol Summary
The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.
Study Locations
Location
Status
Location
SunValley Arthritis Center, Lt /ID# 154558
Peoria, Arizona, United States, 85381
Status
Not applicable
Location
AZ Arthritis & Rheum Research /ID# 156539
Sun City, Arizona, United States, 85351
Status
Not applicable
Location
AZ Arth & Rheum Res /ID# 167161
Tucson, Arizona, United States, 85704
Status
Not applicable
Location
CHI St. Vincent Medical Group /ID# 154561
Hot Springs, Arkansas, United States, 71913-6999
Status
Not applicable
Location
Saint Jude Heritage /ID# 158833
Fullerton, California, United States, 92835
Status
Not applicable
Location
Kotha and Kotha /ID# 154573
La Mesa, California, United States, 91942
Status
Not applicable
Showing {first} - {last} of {total} Results