Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 418
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

Detailed description:

Arms:
arm 1: BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo arm 2: BMS-945429 + Methotrexate + Adalimumab Placebo arm 3: BMS-945429 + Methotrexate + Adalimumab Placebo arm 4: BMS-945429 + Methotrexate + Adalimumab Placebo arm 5: BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo arm 6: BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo arm 7: Adalimumab + Methotrexate

Interventions: intervention 1: BMS-945429 Placebo intervention 2: BMS-945429 intervention 3: BMS-945429 intervention 4: BMS-945429 intervention 5: BMS-945429 intervention 6: Methotrexate intervention 7: Methotrexate intervention 8: Methotrexate Placebo intervention 9: Methotrexate intervention 10: Adalimumab Placebo intervention 11: Adalimumab
Intervention descriptions: intervention 1: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only intervention 2: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only intervention 3: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks intervention 4: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 intervention 5: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks intervention 6: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only intervention 7: Tablets, Oral, 15 mg, Weekly, 48 weeks intervention 8: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only intervention 9: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only intervention 10: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks intervention 11: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks

Protocol document: