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
Completed · Phase 3 · Has a placebo group
Conditions studied: Rheumatoid Arthritis (RA)
In brief
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.
Key facts
- Study ID
- NCT03086343
- Run by
- AbbVie
- People needed
- 657
- Starts
- 2017-05-09
- Expected to finish
- 2023-06-06
- Last updated by the study team
- 2024-07-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- AZ Arthritis & Rheum Research /ID# 156539 — Sun City, Arizona, United States
- AZ Arth & Rheum Res /ID# 167161 — Tucson, Arizona, United States
- CHI St. Vincent Medical Group /ID# 154561 — Hot Springs, Arkansas, United States
- Saint Jude Heritage /ID# 158833 — Fullerton, California, United States
- Kotha and Kotha /ID# 154573 — La Mesa, California, United States
- Denver Arthritis Clinic /ID# 159195 — Denver, Colorado, United States
- Arthritis and Rheum Clin N. CO /ID# 155673 — Fort Collins, Colorado, United States
- Scientia Medical Research /ID# 159189 — Lakewood, Colorado, United States
- Clinical Res of West FL, Inc. /ID# 154576 — Clearwater, Florida, United States
- Advanced Clin Res of Orlando /ID# 154580 — Ocoee, Florida, United States
- Gulf Region Clinical Res Inst /ID# 154597 — Pensacola, Florida, United States
- W. Broward Rheum Assoc Inc. /ID# 158835 — Tamarac, Florida, United States
- Lovelace Scientific Resources /ID# 154600 — Venice, Florida, United States
- Jefrey D. Lieberman, MD, P.C. /ID# 157178 — Decatur, Georgia, United States
- Advanced Clinical Research /ID# 154603 — Meridian, Idaho, United States
- PMG Research of Christie Clini /ID# 154569 — Champaign, Illinois, United States
- Bluegrass Community Research /ID# 154604 — Lexington, Kentucky, United States
- Four Rivers Clinical Research /ID# 154606 — Paducah, Kentucky, United States
- Ochsner Clinic Foundation /ID# 154585 — Baton Rouge, Louisiana, United States
- The Center for Rheumatology & Bone Research /ID# 158723 — Wheaton, Maryland, United States
- West Michigan Rheumatology /ID# 154551 — Grand Rapids, Michigan, United States
- Advanced Rheumatology, PC /ID# 154589 — Lansing, Michigan, United States
- Clinvest Research LLC /ID# 154554 — Springfield, Missouri, United States
- Overlook Medical Center /ID# 154794 — Summit, New Jersey, United States
- SunValley Arthritis Center, Lt /ID# 154558 — Peoria, Arizona, United States
Full record on ClinicalTrials.gov
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