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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: Infliximab

Detailed Description

This study population was chosen from a non-probability sample

• Study Type: Observational
• Enrollment (Actual): 348

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• Subjects with active luminal and/or fistulizing CD.

Exclusion Criteria:

• Per summary of product characteristics.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Remicade; SCH 215596

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: Centocor, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (Estimate): July 30, 2008

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: P04052