Post Marketing Surveillance of Remicade

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

938 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn's Disease Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Serious Active Crohns Disease

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.

Infliximab

Intervention Type BIOLOGICAL

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

Fistula-Type Active Crohns Disease

Patients with fistula-type Crohns Disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.

Infliximab

Intervention Type BIOLOGICAL

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

Ankylosing Spondylitis

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.

Infliximab

Intervention Type BIOLOGICAL

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

Interventions

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Infliximab

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

Intervention Type BIOLOGICAL

Other Intervention Names

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SCH 215596 Remicade

Eligibility Criteria

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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.