A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis
Study Identifier
M16-063
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
Plain Language Summary
Available Language(s): English, Dutch, Czech, Hungarian, Polish, Spanish
Study Details
Medical Condition
Study Drug
Phase
Phase 2
Sex
Female & Male
Age
18+ years
Protocol Summary
This was a phase 2 study to evaluate the safety and efficacy of elsubrutinib (ELS) and ABBV-599 (ELS plus upadacitinib \[UPA\]) vs placebo on a background of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) at 12 weeks in biological disease-modifying anti-rheumatic drugs (bDMARD)-inadequate response (bDMARD-IR) or bDMARD-intolerant participants with moderately to severely active RA and to define optimal dose for further development.
Study Locations
Location
Status
Location
Rheum Assoc of North Alabama /ID# 167382
Huntsville, Alabama, United States, 35801
Status
Not applicable
Location
AZ Arthritis & Rheum Research /ID# 167446
Mesa, Arizona, United States, 85210
Status
Not applicable
Location
SunValley Arthritis Center, Lt /ID# 213073
Peoria, Arizona, United States, 85381
Status
Not applicable
Location
AZ Arthritis and Rheum Researc /ID# 167448
Phoenix, Arizona, United States, 85032
Status
Not applicable
Location
St. Joseph Heritage Healthcare /ID# 167379
Fullerton, California, United States, 92835
Status
Not applicable
Location
Purushotham, Akther & Roshan K /ID# 168121
La Mesa, California, United States, 91942
Status
Not applicable
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