Post Marketing Surveillance of Remicade

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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Key information

Conditions

Crohn's Disease Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infliximab

Biological

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

Other names: SCH 215596, Remicade

Primary outcomes

To evaluate the safety of Remicade Injection (Infliximab) when used in clinical practice

Time frame: 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 outcomes

To evaluate the efficacy of Remicade Injection (Infliximab) when used in clinical practice

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Jul 29, 2008
Registry last updated: Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed