drugset / Trial / NCT02049138
An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib in adults with rheumatoid arthritis (RA) who have completed a preceding randomized controlled trial with upadacitinib.
Timeline
- Start
- 2014-01-24
- Primary completion
- 2021-07-29
- Completion
- 2021-07-29
Publications
- Baraliakos X, van der Heijde D, Sieper J, Inman RD, Kameda H, Li Y, Bu X, Shmagel A, Wung P, Song IH, Deodhar A. Efficacy and safety of upadacitinib in patients with ankylosing spondylitis refractory to biologic therapy: 1-year results from the open-label extension of a phase III study. Arthritis Res Ther. 2023 Sep 18;25(1):172. doi: 10.1186/s13075-023-03128-1.
- Kivitz A, Wells AF, Vargas JI, Baraf HSB, Rischmueller M, Klaff J, Khan N, Li Y, Carter K, Friedman A, Durez P. Long-Term Efficacy and Safety of Upadacitinib in Patients with Rheumatoid Arthritis: Final Results from the BALANCE-EXTEND Open-Label Extension Study. Rheumatol Ther. 2023 Aug;10(4):901-915. doi: 10.1007/s40744-023-00557-x. Epub 2023 May 18.
- Winthrop K, Vargas JI, Drescher E, Garcia C, Friedman A, Hendrickson B, Li Y, Klaff J, Kivitz A. Evaluation of response to 13-valent conjugated pneumococcal vaccination in patients with rheumatoid arthritis receiving upadacitinib: results from a phase 2 open-label extension study. RMD Open. 2022 Mar;8(1):e002110. doi: 10.1136/rmdopen-2021-002110.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prevnar 13 | Vaccine | 0.5 ml | Intramuscular |
| Subject | Upadacitinib | Small molecule | 15 mg | Oral |
| Subject | Upadacitinib | Small molecule | 30 mg | Oral |