Post Marketing Surveillance of Remicade
This study has been completed.
Sponsor:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT00724529
First received: July 25, 2008
Last updated: January 21, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease Ankylosing Spondylitis |
Biological: Infliximab |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD) |
Resource links provided by NLM:
Further study details as provided by Janssen Korea, Ltd., Korea:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 938 |
| Study Start Date: | June 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Serious Active Crohns Disease
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
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:
|
|
Fistula-Type Active Crohns Disease
Patients with fistula-type Crohns Disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
|
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.
Other Names:
|
|
Ankylosing Spondylitis
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.
Other Names:
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
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.
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT00724529 History of Changes |
| Other Study ID Numbers: | CR100771, REMICADECRD4015 |
| Study First Received: | July 25, 2008 |
| Last Updated: | January 21, 2013 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Crohn's Disease Ankylosing Spondylitis |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Spondylitis Spondylitis, Ankylosing Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases |
Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013