A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
Study Identifier
M19-944
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2022-501018-78-00
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, Bulgarian, Czech, German (Belgium), German, Spanish, French (Belgium), French, Hungarian, Japanese, Dutch (Belgium), Polish, Slovak, Turkish, Ukrainian
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+ years
Protocol Summary
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently.
The main objectives of this protocol are:
- To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).
- To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2).
- To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2).
- To evaluate the maintenance of disease control after withdrawal of upadacitinib.
Study Locations
Location
Status
Location
Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282
Flagstaff, Arizona, United States, 86001-6269
Status
Not applicable
Location
AZ Arthritis and Rheumotology Research, PLLC /ID# 215113
Phoenix, Arizona, United States, 85032-9306
Status
Not applicable
Location
Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731
Tucson, Arizona, United States, 85704
Status
Not applicable
Location
Newport Huntington Medical Group /ID# 216281
Huntington Beach, California, United States, 92648-5994
Status
Not applicable
Location
Inland Rheum & Osteo Med Grp /ID# 215807
Upland, California, United States, 91786
Status
Not applicable
Location
Denver Arthritis Clinic /ID# 215346
Denver, Colorado, United States, 80230
Status
Not applicable
Showing {first} - {last} of {total} Results