The purpose of the study is to assess the efficacy, safety and tolerability of JNJ-39758979 at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance) in patients with active rheumatoid arthritis despite concomitant treatment with methotrexate (MTX).
This is a double-blind (neither physician nor patient knows if the patient is receiving JNJ-39758979 or placebo), multicenter, randomized (patients are assigned to treatment by chance), placebo-controlled, dose range finding study of JNJ-39758979 in patients with stable methotrexate treatment through Week 24. The study will consist of 4 periods: a screening period, a 24-week placebo-controlled period, a 24-week extension period, and a 5-week safety follow-up period. The duration of participation in the study for an individual patient will be up to 59 weeks (including screening). All patients will be randomly assigned in a 1:1:1:1:1 ratio to receive placebo or JNJ-39758979 10 mg, 30 mg, 100 mg, or 300 mg once daily. At Week 24, all patients remaining in the placebo group will start to receive JNJ-39758979 300 mg/day. Safety assessments and evaluations to determine the efficacy of JNJ-39758979 to reduce the signs and symptoms of rheumatoid arthritis will be performed at study visits. The extension and safety follow-up periods of this study will continue through Week 53 in order to assess the safety and for maintenance of efficacy of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Form = tablet, route = oral adminstration placebo once daily from Week 0 to Week 24 followed by JNJ-39758979 300 mg once daily from Week 24 to Week 48.
Form = tablet, route = oral adminstration once daily up to 48 weeks
Form = tablet, route = oral adminstration once daily up to 48 weeks
The primary end point is change from baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12
Time frame: Baseline, Week 12
Change from baseline in DAS28 (CRP) at Week 24
Time frame: Baseline, Week 24
Change from baseline in DAS28 (ESR) at Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24
DAS28 (CRP) response rates at Week 12 and Week 24
Time frame: Week 12, Week 24
DAS28 (ESR) response rates at Week 12 and Week 24
Time frame: Week 12, Week 24
DAS28 (CRP) remission rates at Week 12 and Week 24
Time frame: Week 12, Week 24
American college of rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24
Time frame: Week 12, Week 24
Hybrid ACR response at Week 12 and Week 24
Time frame: Week 12, Week 24
ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24
Time frame: Week 12, Week 24
Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24
Time frame: Baseline, Week 12, Week 24
Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Form = tablet, route = oral adminstration once daily up to 48 weeks
Form = tablet, route = oral adminstration once daily for 48 weeks
Time frame: Baseline, Week 12, Week 24
Health Assessment Questionnaire - Disability Index (HAQ-DI) response at Week 12 and Week 24
Time frame: Week 12, Week 24
Change from baseline in HAQ-DI score at Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24
Percent change from baseline in ESR levels at Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24
Percent change from baseline in ACR components at Week 12 and Week 24
Time frame: Baseline, Week 12 and Week 24