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Study Complete
Sponsor ID
20090061

AMG 827 in Rheumatoid Arthritis Subjects with Inadequate Response to Methotrexate

Sponsor ID
20090061
Clinicaltrials.gov ID
NCT00950989
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 2
Product
AMG 827
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
240
Additional Study Details

Protocol Summary

Primary Outcome Measures

To evaluate the efficacy of AMG 827 compared with placebo as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 50 response at week 12.

Timeframe: 12 weeks

Secondary Outcome Measures

To evaluate the efficacy of AMG 827 as measured by the following: The proportion of subjects with an ACR 20 and 70 at week 12 and Disease Activity Score 28 joint (DAS28) at week 12.

Timeframe: 12 weeks

To evaluate the short term safety profile of AMG 827 in subjects with rheumatoid arthritis (RA)

Timeframe: 16 weeks

To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Rheumatoid Arthritis (RA)

Timeframe: 16 weeks

Study Documents

Study Synopsis
Available Language(s): English
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Locations

No locations found.
Study Info
Age
18 - 70 Years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Dec 2009 - Feb 2011
    Inclusion and Exclusion 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