[M23-700] Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants with Moderate to Severe Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2071230022
- Lead Sponsor
- Otani Tetsuya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 480
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein (DAS28-CRP) <=3.2
- Secondary Outcome Measures
Name Time Method - Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response<br>- Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) < 2.6<br>- Change from Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])<br>- Change from Baseline in Participants Assessment of Pain<br>- Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score