Post Marketing Surveillance of Remicade

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00724529

Enrollment

938

Registered

2008-07-29

Start date

2007-06-30

Completion date

2011-08-31

Last updated

2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Crohn's Disease

Keywords

Crohn's Disease, Ankylosing Spondylitis

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.

Interventions

BIOLOGICALInfliximab

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	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

Measure	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026