An observational study in Crohn's Disease and Ankylosing Spondylitis, sponsored by Janssen Korea, Ltd., Korea. Completed. Per ClinicalTrials.gov, last updated 2013-01-23.
Sponsored by Janssen Korea, Ltd., Korea · Observational
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.
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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 938 is above the median of 202 across 256 observational studies indexed under Spondylitis.
Browse Spondylitis studies →Janssen Korea, Ltd., Korea is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population of subjects will mainly be taken from the digestive or rheumatoid departments of internal medicine in university or general hospitals, where patients with Crohn's Disease and Ankylosing Spondylitis are generally treated. The period of surveillance is from 23 AUG 2005 to 22 AUG 2011.
Exclusion Criteria:
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
Patients with fistula-type Crohns Disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
Biological: Infliximab
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
Infliximab 5 mg/kg IV given in a schedule according to the official label, based on the indication it is being used for.
Also known as: SCH 215596, Remicade
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.
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.
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Janssen Korea, Ltd., Korea