An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis Subjects
Completed
AbbVie
Phase 2
2014-01-24
This is a Phase 2, multicenter, open-label extension study in RA subjects. The sub-study is
to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background MTX on
immunological responses to Prevnar 13® in RA patients.
A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
Active, not recruiting
AbbVie
Phase 3
2015-12-17
The primary objectives of this study are to compare the efficacy, safety, and tolerability of
upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and
symptoms of adults with moderately to severely active rheumatoid arthritis who were on a
stable dose of csDMARDs and had an inadequate response to csDMARDs.
A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
Active, not recruiting
AbbVie
Phase 3
2016-03-15
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of
30 mg once daily (QD) and 15 mg QD upadacitinib versus placebo for the treatment of signs and
symptoms of participants with moderately to severely active RA who were on a stable dose of
csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety,
tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who
completed Period 1.
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