'Rheumatoid Arthritis' and 'Rheumatism'
Conditions
Interventions
Subjects who are randomized in the ABT-494 treatment groups will start their
dose ABT-494 30 mg QD or ABT-494 15 mg QD orally at Baseline and must take
their oral dose of medication once daily for 1
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 receiving csDMARD therapy * 3 months and on a stable dose for * 4 weeks prior to the first dose of study drug: **Subjects must have failed at least one of the following: MTX, sulfasalazine, or leflunomide. **Subjects with inadequate response to hydroxychloroquine and/or chloroquine can only be included if they have also failed MTX, sulfasalazine, or leflunomide. **The following csDMARDs are allowed (stable dose for * 4 weeks prior to the first dose of study drug): oral or parenteral MTX (15 to 25 mg/week; or * 10 mg/week in subjects who are intolerant of MTX at doses * 15 mg/week), sulfasalazine (* 3000 mg/day), hydroxychloroquine (* 400 mg/day), chloroquine (* 250 mg/day), and leflunomide (* 20 mg/day). **A combination of up to two background csDMARDs is allowed EXCEPT the combination of MTX and leflunomide.;4. 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 * 3 mg/L (central lab) at Screening Visit.;5. Subjects with prior exposure to at most one bDMARD may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (* 3 months).
Exclusion criteria
Exclusion criteria: 1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib);2. Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.;3. 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 ACR20 response (US/FDA regulatory purposes) or the proportion of subjects achieving LDA (EU/EMA regulatory purposes) at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ranked secondary endpoints (at Week 12) are: 1. Change from baseline in DAS28 (CRP); 2. Change from baseline in HAQ-DI; 3. ACR50 response; 4. ACR70 response; 5. Change from baseline in Short Form-36 (SF-36) Physical Component Score (PCS); 6. Proportion of subjects achieving LDA based on DAS28 (CRP) * 3.2; 7. Proportion of subjects achieving clinical remission (CR) based on DAS28 (CRP); 8. Change from baseline in FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue); 9. Change from baseline in RA-WIS (Work Instability Scale for Rheumatoid Arthritis); 10. Change from baseline in morning stiffness (severity). 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]); * Change from baseline in morning stiffness (severity and duration); * Proportion of subjects achieving LDA and proportion of subjects achieving CR based on DAS28 (CRP), DAS28 (ESR), Simplified Disease Activity Index (SDAI), and CDAI criteria * Change from baseline in EQ-5D-5L; * Change from baseline in SF-36. Assessments to evaluate efficacy of treatment in Period 2 will be analyzed for above-mentioned measures at Weeks 16, 20, 24, 36, 48 and every 12 weeks thereafter until completion of the study. | — |
Countries
Netherlands
Outcome results
None listed