[M23-700] A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

Otani Tetsuya0 个研究点目标入组 480 人开始时间: 2023年6月18日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American College of
•Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA.
•- Treated for >= 3 consecutive months prior to screening with 1 tumor necrosis factor inhibitor (TNFi) (originator or biosimilar) for RA (except adalimumab [originator or biosimilar]), but continue to exhibit active RA, or had to discontinue due to intolerability, irrespective of treatment duration. Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll.
•- On oral or parenteral methotrexate (MTX) therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation.
•-- For participants in China, Japan, Korea, or Taiwan, a stable dose of MTX >= 7.5 mg/week is acceptable.
•-- Additional local requirements for MTX may apply.
•- Meets both of the following disease activity criteria:
•-- >= 6 swollen joint (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at screening and baseline;(central lab, upper limit of normal [ULN] 2.87 mg/L) at screening.
•-- High-sensitivity C-reactive protein (hsCRP) >= 3 mg/

•- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA).
•- Prior exposure to any janus kinase (JAK) inhibitor.
•- Prior exposure to adalimumab (original or biosimilar).
•- Prior exposure to a non-TNFi biologic disease modifying anti-rheumatic drug (bDMARD).

发起方

Otani Tetsuya