Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)

Crohn's Disease Clinical Trial

Official title:

Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724958
• Other study ID #: P04052
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: October 1, 2015
• Start date: December 2004
• Est. completion date: July 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: No HA submission required
• Study type: Observational

Clinical Trial 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.

Description:

This study population was chosen from a non-probability sample

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects with active luminal and/or fistulizing CD.

Exclusion Criteria:

• Per summary of product characteristics.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Infliximab
Not specified in the protocol.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Centocor, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)	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).	up to 2 years	No
Primary	Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)	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).	up to 2 years	No
Primary	Average Dose of Infliximab Per Participant Within the Observation Period	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).	up to 2 years	No
Primary	Median Dose of Infliximab Per Participant Within the Observation Period	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).	up to 2 years	No
Primary	Total Dose of Infliximab Per Participant Within the Observation Period	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).	up to 2 years	No
Secondary	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.	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).	5 years	No