Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: Infliximab (Biological)
Phase: N/A
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
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.
Clinical Details
Official title: Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) Average Dose of Infliximab Per Participant Within the Observation Period Median Dose of Infliximab Per Participant Within the Observation Period Total Dose of Infliximab Per Participant Within the Observation Period
Secondary outcome: 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.
Detailed description:
This study population was chosen from a non-probability sample
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with active luminal and/or fistulizing CD.
Exclusion Criteria:
- Per summary of product characteristics.
Locations and Contacts
Additional Information
Starting date: December 2004
Last updated: October 23, 2014
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