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

About the trial

Sponsor

AbbVie

Tested

Abatacept (drug), Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion) (drug), Upadacitinib (drug), Placebo for upadacitinib (drug)

Dates

Started 2017-05-09; completion 2023-06-06

Results posted

Yes

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.

From ClinicalTrials.gov, last updated 2024-07-18. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $3,702 in research payments for this study in 2025 (5 payments).

Products named: Rinvoq

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.