Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis

Study Identifier
P11-973
CT.gov Identifier
NCT01076205
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol and Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs * Inclusive methotrexate * Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before; In case of incompatibility with methotrexate, Humira can be used as monotherapy.
    Exclusion Criteria:
    * Hypersensitivity against the drug or one of the other ingredients * Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) * Moderate to severe cardiac insufficiency

    Protocol Summary

    The AGIL study was designed to evaluate the effectiveness and safety of adalimumab over 5 years in routine daily clinical practice in Germany, with a focus on the impact of therapy on employment-related outcomes.

    Study Locations

    No locations found.