A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
- 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
- EUCTR2015-003376-75-PL
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
• Adult male or female, at least 18 years old.
• Diagnosis of RA for = 3 months.
• Subjects must have been on oral or parenteral MTX therapy = 3 months and on a stable dose for = 4 weeks prior to first dose of study drug.
• Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) = 4 weeks prior to first dose of study drug.
• Meets the following minimum 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.
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 465
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135
• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
• History of any arthritis with onset prior to age 17 years or current
diagnosis 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 (signs and symptoms) of upadacitinib (ABT-494) monotherapy versus MTX in MTX-inadequate response (MTX-IR) subjects with moderately to severely active rheumatoid arthritis (RA).<br>• To evaluate the long-term safety, tolerability, and efficacy of upadacitinib (ABT-494) in subjects with RA.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the proportion of subjects achieving low disease activity (LDA) at Week 14.;Timepoint(s) of evaluation of this end point: Week 14
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Week 14;Secondary end point(s): • Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP])<br>• Change from baseline in HAQ-DI (Health Assessment Questionnaire - Disability Index)<br>• ACR20 response rate<br>• ACR50 response<br>• ACR70 response<br>• Change from Baseline in Short Form-36 (SF-36) Physical Component Score (PCS)<br>• Proportion of subjects achieving CR based on DAS28 (CRP)<br>• Change from baseline in morning stiffness (duration)<br>