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Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

This study is currently Recruiting

August 2011 By Abbott

First Recieved on August 5, 2011

Last Updated on August 5, 2011

Sponsor: Abbott
Collaborators:
Information provided by: Abbott
Identifier: NCT01412021

Purpose

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints 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 Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:N/A
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira 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

Investigators

  • Investigator: Toshiro Maeda - Study Director - Abbott Japan Co.,Ltd

Locations

  • Site Ref # / Investigator 60666

    Okayama, Japan

  • Site Ref # / Investigator 60665

    Osaka, Japan

  • Site Ref # / Investigator 49892

    Tokyo, Japan

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