AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to Methotrexate

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, double-blind, placebo-controlled study in subjects with RA who have an inadequate response to methotrexate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Brodalumab; Methotrexate

Criteria

Inclusion Criteria:

• Active RA for least 6 months

• Current RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal joints) and at least 1 of the following at screening: Erythrocyte sedimentation rate ≥ 28 mm or C-reactive protein > 15 mg/L

• At least 1 of the following at screening: Rheumatoid factor positive or Anti-cyclic citrullinated peptide antibody positive

• Currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at 15 to 25 mg weekly for ≥ 4 weeks at day -1.

Exclusion Criteria:

• Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening

• Class IV RA

• Felty's syndrome

• Presence of serious infection

• Significant concurrent medical conditions

• Pregnant or breast feeding

• Significant Laboratory abnormalities

• Any DMARD other than methotrexate within 28 days

• Leflunomide or live vaccines within 3 months

• Previous use of any experimental or commercially available biologic DMARD