Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Collaborator:
Centocor, Inc.
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00724958
First received: July 25, 2008
Last updated: September 16, 2011
Last verified: September 2011
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Purpose
The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.
| Condition | Intervention |
|---|---|
|
Crohn's Disease |
Biological: Infliximab |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
Drug Information available for:
Infliximab
U.S. FDA Resources
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
- Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
- Average Dose of Infliximab Per Participant Within the Observation Period [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
- Median Dose of Infliximab Per Participant Within the Observation Period [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
- Total Dose of Infliximab Per Participant Within the Observation Period [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Secondary Outcome Measures:
- Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease).
| Enrollment: | 348 |
| Study Start Date: | December 2004 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Remicade
Subjects with active luminal and/or fistulizing CD in the hospital or non-hospital setting.
|
Biological: Infliximab
Not specified in the protocol.
Other Names:
|
Detailed Description:
This study population was chosen from a non-probability sample
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects with active luminal and/or fistulizing CD who are treated with Remicade in the hospital and non-hospital setting.
Criteria
Inclusion Criteria:
- Subjects with active luminal and/or fistulizing CD.
Exclusion Criteria:
- Per summary of product characteristics.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00724958 History of Changes |
| Other Study ID Numbers: | P04052 |
| Study First Received: | July 25, 2008 |
| Results First Received: | July 13, 2011 |
| Last Updated: | September 16, 2011 |
| Health Authority: | Austria: No HA submission required |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Infliximab |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013