Special Investigation in Patients With Ulcerative Colitis

Study Identifier
P14-190
CT.gov Identifier
NCT01947816
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

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
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    N/A - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patients receiving Humira for the first time for the treatment of Ulcerative Colitis
    Exclusion Criteria:
    Contraindications according to the Package Insert include patients who have any of the following: * serious infections * tuberculosis * a history of hypersensitivity to any ingredient of Humira * demyelinating disease or a history of demyelinating disease * congestive cardiac failure

    Protocol Summary

    This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.

    1. Unknown adverse reactions (in particular, clinically significant)

    2. Incidence and conditions of occurrence of adverse reactions in clinical practice

    3. Factors likely to affect the safety and effectiveness

    Study Locations

    No locations found.