Post Marketing Surveillance of Remicade

Completed

• Conditions: Crohn's Disease; Ankylosing Spondylitis
• Interventions: Biological: Infliximab

• Registration Number: NCT00724529
• Lead Sponsor: Janssen Korea, Ltd., Korea

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-29
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 938

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ankylosing Spondylitis	Infliximab	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.
Fistula-Type Active Crohns Disease	Infliximab	Patients with fistula-type Crohns Disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
Serious Active Crohns Disease	Infliximab	Patients with severe active Crohns Disease who do not show any response to treatment with corticosteroids or immunosuppressive agents, and have no drug tolerance or contraindications to such treatments.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.