Post Marketing Surveillance of Remicade

Study Overview
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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.

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.

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

Conditions
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Crohn's Disease, Ankylosing Spondylitis

Intervention / Treatment
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* Biological: Infliximab


Participation Criteria
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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. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Serious Active Crohns Disease<br>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. | Biological: Infliximab<br>* Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.<br>* Other names: Remicade;|
| Fistula-Type Active Crohns Disease<br>Patients with fistula-type Crohns Disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant. | Biological: Infliximab<br>* Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.<br>* Other names: Remicade;|
| Ankylosing Spondylitis<br>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. | Biological: Infliximab<br>* Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.<br>* Other names: Remicade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Ankylosing Spondylitis