Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: ABT-494
Pharmaceutical Form: Tablet
INN or Proposed INN: ABT-494
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female, at least 18 years old. 2. Diagnosis of RA for = 3 months. 3. Subjects have been treated for = 3 months with = 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration and have never received abatacept prior to the first dose of study drug. 4. 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. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide. 5. Meets the following criteria: = 6 swollen joints (based on 66 joint counts) and = 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits and hsCRP = 3 mg/L 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 225 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). 2. Prior exposure to abatacept 3. History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. ACR20 response rate at Week 12 (non-inferiority); 2. Change from baseline in DAS28 (CRP) at Week 12 (non-inferiority); 3. Change from baseline in DAS28 (CRP) at Week 12 (superiority).;Primary end point(s): The primary endpoint is the proportion of subjects achieving low disease activity (LDA) at Week 12. LDA is defined as Disease Activity Score (DAS)28 (C-reactive protein [CRP]) = 3.2 (non-inferiority).;Timepoint(s) of evaluation of this end point: Week 12;Main Objective: 1. To compare the safety and efficacy of ABT-494 versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-intolerant subjects with moderately to severely active RA. 2. To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. ACR20 response rate at Week 12 (non-inferiority); 2. Change from baseline in DAS28 (CRP) at Week 12 (non-inferiority); 3. Change from baseline in DAS28 (CRP) at Week 12 (superiority).;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Argentina, Australia, Belarus, Brazil, Canada, Chile, Colombia, European Union, Hungary, Israel, Korea, Democratic People's Republic of, Latvia, Mexico, New Zealand, Norway, Puerto Rico, Russian Federation, Spain, Switzerland, Turkey, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd
Outcome results
None listed