A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis

Study Identifier
M11-328
CT.gov Identifier
NCT01166282
EudraCT Identifier
2009-017938-46
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Immune & Inflammatory - Other
    • Study Drug
  • adalimumab
  • placebo for adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    6 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of Enthesitis Related Arthritis (ERA) as defined by International League of Associations for Rheumatology (ILAR); * Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location; * Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.
    Exclusion Criteria:
    * Any ILAR Juvenile Idiopathic Arthritis (JIA) subtype other than ERA; * Psoriasis or a history of psoriasis in the patient or first-degree relative; * Presence of Immunoglobulin M (IgM) rheumatoid factor; * Presence of systemic JIA; * History of inflammatory bowel disease; * previous biologic therapy including anti-tumor necrosis factor (anti-TNF) therapy with a potential impact on pediatric ERA; * Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline.

    Protocol Summary

    The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA).

    Study Locations

    No locations found.