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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

Page last updated: August 23, 2015

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