'Rheumatoid Arthitis' and 'Rheumatism'
Conditions
Interventions
Subjects who are assigned to ABT-494 15 mg will start oral at 15 mg/day at
Baseline. Subjects who are assigned to ABT-494 30 mg will start oral at 30
mg/day at Baseline. Subjects who are assigned to
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. Naïve to MTX or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.;4. Subjects with prior exposure to csDMARDs other than MTX may be enrolled if completed the washout period as specified below or should be at least five times the mean terminal elimination half-life of a drug: *** 4 weeks prior to first dose of study drug for minocycline, penicillamine, sulfasalazine, hydroxychloroquine, chloroquine, azathioprine, gold formulations, cyclophosphamide, tacrolimus, cyclosporine, mycophenolate; *** 8 weeks prior to first dose of study drug for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure.;5. Subject meets both of the following disease activity criteria: a. * 6 swollen joints (based on 66 joint counts) and * 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits; and b. hsCRP * 5 mg/L (central lab, ULN 2.87 mg/L) at Screening Visit.
Exclusion criteria
Exclusion criteria: 1. Intolerant to MTX.;2. Prior exposure to any JAK inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).;3. Prior exposure to any bDMARD(s).;4. History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in Period 1 is the proportion of subjects achieving ACR50 response (US/FDA regulatory purposes) or the proportion of subjects achieving Clinical Remission (CR) (EU/EMA regulatory purposes) at Week 24. For Japan/PMDA regulatory purposes, the primary endpoints are the proportion of subjects achieving ACR20 response and change from baseline in modified Total Sharp Score (mTSS) at Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ranked secondary endpoints are: 1. Change from baseline in DAS28 (CRP); 2. Change from baseline in HAQ-DI; 3. ACR20 response rate; 4. ACR50 response rate; 5. Change from baseline in modified Total Sharp Score (mTSS); 6. ACR70 response rate; 7. Proportion of subjects achieving LDA based on DAS28 (CRP) * 3.2; 8. Change from baseline in SF-36 PCS; 9. Proportion of subjects with no radiographic progression (defined as change from baseline in mTSS * 0) at Weeks 24 and 48. Additional endpoints at all visits are: * Change from baseline in individual components of ACR response; * ACR20/50/70 response rates; * Change from baseline in DAS28(CRP) and DAS28 (erythrocyte sedimentation rate [ESR]); * Proportion of subjects achieving LDA or CR by DAS28(CRP), DAS28(ESR), Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI); * Change from baseline in morning stiffness (severity and duration); Additional endpoints (at Weeks 12, 24, and 48) are: * Change from baseline in EQ-5D-5L; * Change from baseline in FACIT-F; * Change from baseline in WPAI; * Change from baseline in SF-36. Additional endpoints (at Weeks 24 and 48) are: * Change from baseline in mTSS; * Proportion of subjects with no radiographic progression (defined as change from baseline in mTSS * 0); * Change from baseline in radiographic joint space narrowing and erosion scores. Assessments to evaluate efficacy of treatment in Period 2 will be analyzed for above-mentioned measures at Weeks 60, 72, 84, 96 and every 12 weeks thereafter until completion of the study. | — |
Countries
Netherlands
Outcome results
None listed