Rheumatoid Arthritis and Rheumatism
Conditions
Interventions
Subjects who meet eligibility criteria will be randomized in a 1:1 ratio to one
of two treatment groups:
• Group 1: upadacitinib tablet QD, (Period 1)
• Group 2: Abatacept IV at Day 1, Weeks 2, 4, 8,
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
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.
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. Current diagnosis of secondary Sjogren's Syndrome is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in DAS28 (CRP) (non-inferiority). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: 1. Change from baseline in DAS28 (CRP) at Week 12 (superiority); 2. Proportion of subjects achieving Clinical Remission (CR) at Week 12 (superiority) | — |
Countries
Netherlands
Outcome results
None listed