Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis ACR Methotrexate Interleukin-22
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 195
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.

Detailed description:

Arms:
arm 1: Part 1: Placebo arm 2: Part 1: 100 mg ILV-094 SC Q4W arm 3: Part 1: 100 mg ILV-094 SC Q2W arm 4: None arm 5: Part 2: 200 mg ILV-094 SC Q2W

Interventions: intervention 1: Placebo intervention 2: ILV-094 intervention 3: ILV-094 intervention 4: Placebo intervention 5: ILV-094
Intervention descriptions: intervention 1: Part 1: Placebo SC administration every 2 weeks X 10 weeks. intervention 2: Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks. intervention 3: Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks. intervention 4: Part 2: Placebo SC administration every 2 weeks X 10 weeks intervention 5: Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks

Protocol document: