Status:
COMPLETED
Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate
Lead Sponsor:
Amgen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Study in participants with RA who have an inadequate response to methotrexate.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2011
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00950989
Start Date
December 30 2009
End Date
February 11 2011
Last Update
December 21 2021
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