Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate

Amgen

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Dietary Supplement: folic acid; Drug: Brodalumab; Drug: Methotrexate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00950989

20090061

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 disease-modifying anti-rheumatic drug (DMARD) other than methotrexate within 28 days
• Leflunomide or live vaccines within 3 months
• Previous use of any experimental or commercially available biologic DMARD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: folic acid

Drug: Methotrexate

Drug: Placebo

Brodalumab 70 mg

Experimental group

Description:

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).

Treatment:

Dietary Supplement: folic acid

Drug: Methotrexate

Drug: Brodalumab

Brodalumab 140 mg

Experimental group

Description:

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).

Treatment:

Dietary Supplement: folic acid

Drug: Methotrexate

Drug: Brodalumab

Brodalumab 210 mg

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: folic acid

Drug: Methotrexate

Drug: Brodalumab