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NCT00724529 Clinical Trial

Post Marketing Surveillance of Remicade

Crohn's Disease Clinical Trial

Official title:
Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00724529
Other study ID # CR100771
Secondary ID REMICADECRD4015
Status Completed
Phase Phase 4
First received July 25, 2008
Last updated January 21, 2013
Start date June 2007
Est. completion date August 2011

Study information
Verified date January 2013
Source Janssen Korea, Ltd., Korea
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 938
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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 Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• Infliximab
Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Janssen Korea, Ltd., Korea

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety of Remicade Injection (Infliximab) when used in clinical practice The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis. Yes
Secondary To evaluate the efficacy of Remicade Injection (Infliximab) when used in clinical practice The maximum period for observation in this surveillance would be 30 weeks (6 administrations) for patients with Crohn's disease and 24~30 weeks (6 administrations) for patients with Ankylosing spondylitis. No
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