A Study Comparing 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)

Phase 1

Conditions: Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2015-003332-13-SK

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

• 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). Specifically, prior to enrollment: a. Subjects with limited exposure to bDMARD (< 3 months) OR b. Subjects who are responding to bDMARD therapy but had to discontinue due to intolerability (regardless of treatment duration).
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

Exclusion Criteria

• 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
Main Objective: • To compare the efficacy of ABT-494 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 ABT-494 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 ABT-494 in subjects with RA. ;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
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;Timepoint(s) of evaluation of this end point: Week 12

Related Trials