Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief summary:
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.

Detailed description:

Arms:
arm 1: AIN457A 0.3 mg/kg was administered intravenously as a single dose. arm 2: AIN457A 1.0 mg/kg was administered intravenously as a single dose. arm 3: AIN457A 3.0 mg/kg was administered intravenously as a single dose. arm 4: AIN457A 10.0 mg/kg was administered intravenously as a single dose. arm 5: Placebo to AIN457A was administered intravenously as a single dose. arm 6: AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 7: AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 8: AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 9: Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 10: AIN457A 3.0 mg/kg was administered intravenously as a single dose. arm 11: AIN457A 10 mg/kg was administered intravenously as a single dose. arm 12: Placebo to AIN457A was administered intravenously as a single dose.

Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A. intervention 2: Placebo to AIN457

Protocol document: