Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis

Study Identifier
P12-070
CT.gov Identifier
NCT01163318
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

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
  • Rheumatoid Arthritis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    15+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Participants who received adalimumab in accordance with its indications for treatment and dosage regimens. 2. Participants who used adalimumab continuously. 3. Participants without current or past history of malignant tumors. 4. Participants evaluated for Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR). 5. Participants evaluated by Health Assessment Questionnaire (HAQ) or Modified Health Assessment Questionnaire (MHAQ) prior to the initiation of adalimumab treatment in the all-case PMOS.
    Exclusion Criteria:
    1. Contraindications according to the package insert. 2. Participants with serious infections. 3. Participants with tuberculosis. 4. Participants with a history of hypersensitivity to any ingredient of adalimumab. 5. Participants with demyelinating disease or a history of demyelinating disease. 6. Participants with congestive cardiac failure.

    Protocol Summary

    The purpose of this study was to collect data on the incidence of adverse drug reactions, infections and malignant tumors, as well as factors that might affect the safety and effectiveness of Humira® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the drug for the treatment of rheumatoid arthritis.

    Study Locations

    No locations found.