Status:
COMPLETED
Post Marketing Surveillance of Remicade
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Crohn's Disease
Ankylosing Spondylitis
Eligibility:
All Genders
Brief Summary
The purpose of this study is to understand the safety and effectiveness of infliximab when used in clinical practice. This is a post-marketing surveillance study.
Detailed Description
The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Remicade approval.
Eligibility Criteria
Inclusion
- Severe active Crohn's disease: the patients with severe active Crohn's disease who do not show any response to the treatment with corticosteroid or immunosuppressive agents, have no drug tolerance, or are contraindicated to such treatments.
- Fistula-type active Crohn's disease: the patients with fistula-type active Crohn's disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
- Ankylosing spondylitis: the patients with ankylosing spondylitis who do not show adequate response to general treatments, and with increased serological indices related to severe axial symptoms and inflammation.
Exclusion
- None
Key Trial Info
Start Date :
June 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
938 Patients enrolled
Trial Details
Trial ID
NCT00724529
Start Date
June 1 2007
End Date
August 1 2011
Last Update
January 23 2013
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