A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)
- Conditions
- Moderately to Severely Active Rheumatoid Arthritis (RA)MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-003334-27-IE
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 975
• Adult male or female, at least 18 years old.
• Diagnosis of RA for = 6 weeks.
• Naïve to MTX or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
• Subjects with prior exposure to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) other than MTX may be enrolled if completed the washout period.
• Subject meets the following disease activity criteria: = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
• = 1 bone erosion on x-ray (by local reading) OR in the absence of a documented bone erosion, both positive rheumatoid factor and positive anti-cyclic citrullinated peptide autoantibodies are required at Screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 731
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 244
• Intolerant to MTX.
• Prior exposure to any JAK inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• Prior exposure to any bDMARD(s).
• History of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To compare the safety and efficacy of Upadacitinib monotherapy versus methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis (RA) in MTX-naïve subjects with moderately to severely active RA.<br>• To compare the efficacy of Upadacitinib monotherapy versus MTX monotherapy for prevention of structural progression in MTX-naive subjects with moderately to severely active RA.<br>• To evaluate the long-term safety, tolerability, and efficacy of Upadacitinib in subjects with RA.;Secondary Objective: Not applicable;Primary end point(s): Proportion of subjects achieving Clinical Remission (CR) at Week 24.;Timepoint(s) of evaluation of this end point: week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in DAS28 (CRP)<br>Change from baseline in HAQ-DI<br>ACR20 response rate <br>ACR50 response rate<br>Change from baseline in modified Total Sharp Score (mTSS)<br>ACR70 response rate<br>Proportion of subjects achieving LDA based on DAS28 (CRP) = 3.2<br>Change from baseline in SF-36 PCS <br>Proportion of subjects with no radiographic progression (defined as change from baseline in mTSS = 0) at Weeks 24 and 48.;Timepoint(s) of evaluation of this end point: Week 24