'Rheumatoid Arthritis' and 'Rheumatism'
Conditions
Interventions
Subjects will receive both oral study drug QD (either ABT-494 15 mg or matching
placebo) and subcutaneous study drug eow (either ADA 40 mg or matching placebo).
Subjects must have been on oral or pa
or * 10 mg/week in subjects who are intolerant of MTX at doses * 15
mg/week), and must remain on a stable dose throughout the study.
Subjects in the placebo group who do not achieve a * 20% improvem
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 must have been on oral or parenteral MTX therapy * 3 months and on a stable prescription of 15 to 25 mg/week (or * 10 mg/week in subjects intolerant of MTX at doses * 15 mg/week) for * 4 weeks prior to the first dose of study drug. In addition, all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.;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 * 5 mg/L (central lab, ULN 2.87 mg/L) at Screening Visit.;5. Subject has at least one of the following at Screening: a. * 3 bone erosions on x-ray; or b. * 1 bone erosion and a positive rheumatoid factor; or c. * 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibody.;6. Subjects with prior exposure to only one bDMARD (except ADA) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (
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 have been exposed to adalimumab or 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 at Week 12 (US/FDA regulatory purposes) or the proportion of subjects achieving CR based on DAS28 (CRP) at Week 12 (EU/EMA regulatory purposes). | — |
Secondary
| Measure | Time frame |
|---|---|
| Ranked secondary endpoints of this study are: 1. Proportion of subjects achieving LDA at Week 12; 2. Change from baseline in DAS28 (CRP) at Week 12; 3. Change from baseline in HAQ-DI at Week 12; 4. ACR20 response rate at Week 12; 5. ACR50 response rate at Week 12; 6. ACR70 response rate at Week 12; 7. Proportion of subjects achieving LDA based on based on DAS28 (CRP) * 3.2 at Week 12 8. Change from baseline in SF-36 PCS at Week 12; 9. Proportion of subjects achieving CR based on DAS28 (CRP) at Week 12; 10. Change from baseline in FACIT-F at Week 12; 11. Proportion of subjects with no radiographic progression at Week 26; 12. Change from baseline in RA-WIS at Week 12; 13. Change from baseline in morning stiffness (severity) at Week 12. 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 based on DAS28 (CRP), DAS28 (ESR), Simplified Disease Activity Index (SDAI), and CDAI criteria; * Change from baseline in morning stiffness (severity and duration). Additional endpoints (at Weeks 12, 26, and 48) are: * Change from baseline in EQ-5D-5L. Additional endpoints (at Weeks 26 and 48) are: * Change from baseline in SF-36; * Proportion of subjects with no radiographic progression (defined as change from baseline in mTSS * 0) * Change from baseline in joint space narrowing score and joint erosion score. Asessments 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