A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
Study Identifier
M16-852
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
2023-505476-29-00
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, Czech, Danish, German (Austria), German (Belgium), German (Switzerland), German, Spanish, French (Belgium), French (Switzerland), French, Hungarian, Italian (Switzerland), Italian, Japanese, Dutch (Belgium), Dutch, Norwegian, Portuguese (Native), Swedish, Greek
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
50+ years
Protocol Summary
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.
Study Locations
Location
Status
Location
Rheum Assoc of North Alabama /ID# 168668
Huntsville, Alabama, United States, 35801
Status
Not applicable
Location
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 204702
Glendale, Arizona, United States, 85306-9802
Status
Not applicable
Location
VA Long Beach Healthcare System /ID# 203833
Long Beach, California, United States, 90822-5201
Status
Not applicable
Location
Robin K. Dore MD, Inc /ID# 201950
Tustin, California, United States, 92780
Status
Not applicable
Location
Denver Arthritis Clinic /ID# 171552
Denver, Colorado, United States, 80230
Status
Not applicable
Location
Duplicate_Western Connecticut Health Network- Germantown Rd /ID# 205071
Danbury, Connecticut, United States, 06810-5038
Status
Not applicable
Showing {first} - {last} of {total} Results