CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.
Upadacitinib: RINVOQ
| Study Name | |||
|---|---|---|---|
| M13-845 | Rheumatoid Arthritis | Phase 1 | A Study in Healthy Adult Volunteers and Adult Subjects with Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494 |
| M13-537 | Rheumatoid Arthritis | Phase 2 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone |
| M13-551 | Rheumatoid Arthritis | Phase 1 | A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Dose of ABT-494 in Subjects with Normal and Impaired Renal Function |
| M13-550 | Rheumatoid Arthritis | Phase 2 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy |
| M13-539 | Rheumatoid Arthritis | Phase 1 | A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Dose of ABT-494 in Subjects with Mild or Moderate Hepatic Impairment |