A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy
- Conditions
- Moderately to Severely Active Rheumatoid Arthritis (RA)MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-002358-57-NL
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 276
1. Adult male or female, at least 18 years old.
2. Diagnosed with RA based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for = 3 months.
3. Subjects have been treated with 1 or more anti-TNF biologics (no maximum cap) for = 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s) (no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.
4. Have active RA as defined by the following minimum disease activity criteria:
• = 6 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.
• = 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
• hsCRP > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor (RF) and anti-CCP antibody 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 185
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65
1. Prior exposure to JAK inhibitor (e.g., tofacitinib, baricitinib).
2. Pregnant or breastfeeding female.
3. Any ongoing or active infection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to compare the safety and efficacy of multiple doses of ABT-494 versus placebo in moderately to severely active RA subjects on stable background MTX therapy with inadequate response or intolerance to anti-TNF biologic therapy.;Secondary Objective: Not applicable;Primary end point(s): ACR20 response rate.;Timepoint(s) of evaluation of this end point: Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ACR50/70 response rates, the proportion of subjects achieving low disease activity (LDA) (2.6 = DAS28 [CRP] < 3.2) or clinical remission (CR) (DAS28 [CRP] < 2.6), and the proportion of subjects achieving CR (DAS28 [CRP] < 2.6);Timepoint(s) of evaluation of this end point: Week 12