Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

Study Identifier
P12-764
CT.gov Identifier
NCT01329380
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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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Axial Spondyloarthritis (axSpA)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    16 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey
    Exclusion Criteria:
    * Contraindications according to the Package Insert * Patients who have serious infections * Patients who have tuberculosis * Patients with a history of hypersensitivity to any ingredient of Humira * Patients who have demyelinating disease or with a history of demyelinating disease * Patients who have congestive cardiac failure

    Protocol Summary

    This study of adalimumab (Humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug:

    • Unknown adverse drug reactions (especially important adverse drug reactions)
    • Incidence and conditions of occurrence of adverse reactions in the clinical setting
    • Factors that may affect the safety and effectiveness of Humira

    Study Locations

    Location
    Status
    Location
    Nagoya City University Hospital
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Not applicable
    Location
    Kurume University Hospital
    Kurume-shi, Fukuoka, Japan, 830-0011
    Status
    Not applicable
    Location
    Gunma University Hospital
    Maebashi, Gunma, Japan, 371-8511
    Status
    Not applicable
    Location
    Hyogo College of Medicine Hosp
    Nishinomiya, Hyōgo, Japan, 663-8501
    Status
    Not applicable
    Location
    Yokohama City Univ Medical Ctr
    Yokohama, Kanagawa, Japan, 232-0024
    Status
    Not applicable
    Location
    Nagasaki University Hospital
    Nagasaki, Nagasaki, Japan, 〒852-8102
    Status
    Not applicable
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