Post Marketing Surveillance of Remicade

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Crohn's Disease; Ankylosing Spondylitis

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00724529

REMICADECRD4015 (Other Identifier)

CR100771

Details and patient eligibility

About

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.

Full 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.

Enrollment: 938 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

938 participants in 3 patient groups

Serious Active Crohns Disease

Description:

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.

Treatment:

Biological: Infliximab

Fistula-Type Active Crohns Disease

Description:

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

Treatment:

Biological: Infliximab

Ankylosing Spondylitis

Description:

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.

Treatment:

Biological: Infliximab