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

Completed

• Conditions: Crohn's Disease
• Interventions: Biological: Infliximab

• Registration Number: NCT00724958
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

This study population was chosen from a non-probability sample

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-07-13
• Results First Submitted QC: 2011-09-16
• Results First Posted: 2011-10-26
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

• Subjects with active luminal and/or fistulizing CD.

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Exclusion Criteria

• Per summary of product characteristics.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remicade	Infliximab	Subjects with active luminal and/or fistulizing CD in the hospital or non-hospital setting.

Primary Outcome Measures

Name	Time	Method
Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)	up to 2 years	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)	up to 2 years	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	up to 2 years	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	up to 2 years	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	up to 2 years	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

Name	Time	Method
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.	5 years	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).