A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)
- Conditions
- Moderately to Severely Active Rheumatoid Arthritis (RA)MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-003332-13-FI
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
• Adult male or female, at least 18 years old.
• Diagnosis of RA for = 3 months.
• Subjects have been receiving csDMARD therapy = 3 months and on a stable dose for = 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: MTX, sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
• Meets the 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.
• Subjects with prior exposure to at most one bDMARD may be enrolled (up to 20% of study population).
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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
• Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: • To compare the efficacy of upadacitinib versus placebo for the treatment of signs and symptoms of subjects with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response to csDMARDs.<br> • To compare the safety and tolerability of upadacitinib versus placebo in subjects with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs.<br> • To evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.<br> ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the proportion of subjects achieving ACR20 response / the proportion of subjects achieving LDA at Week 12.;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Week 12;<br> Secondary end point(s): 1. Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP])<br> 2. Change from baseline in HAQ-DI<br> 3. ACR 20 response rate<br> 4. Change from baseline in SF-36 PCS<br> 5. Proportion of subjects achieving Clinical remission (CR) based on DAS28 (CRP)<br> 6. Proportion of subjects achieving LDA based on CDAI = 10;<br> 7. Change from baseline in morning stiffness<br> 8. Change from baseline in FACIT-F<br>