Conditions: Rheumatoid Arthritis
Keywords: Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 252
Healthy volunteers: no

Brief summary:
Study in participants with RA who have an inadequate response to methotrexate.

Detailed description:

Arms:
arm 1: Placebo on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week). arm 2: 70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week). arm 3: 140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexateand folic acid supplementation (at least 5 mg per week). arm 4: 210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).

Interventions: intervention 1: Brodalumab intervention 2: Placebo intervention 3: Methotrexate intervention 4: folic acid
Intervention descriptions: intervention 1: 3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10 intervention 2: 3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10 intervention 3: Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study. intervention 4: at least 5 mg per week

Protocol document: