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

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ClinicalTrials.gov Identifier: NCT00724958
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : October 26, 2011
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Crohn's Disease Biological: Infliximab

Detailed Description:
This study population was chosen from a non-probability sample

Study Type : Observational
Actual Enrollment : 348 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension
Study Start Date : December 2004
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) [ Time Frame: 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).

  2. Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) [ Time Frame: 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).

  3. Average Dose of Infliximab Per Participant Within the Observation Period [ Time Frame: 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).

  4. Median Dose of Infliximab Per Participant Within the Observation Period [ Time Frame: 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).

  5. Total Dose of Infliximab Per Participant Within the Observation Period [ Time Frame: 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 :
  1. 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. [ Time Frame: 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).



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Subjects with active luminal and/or fistulizing CD.

Exclusion Criteria:

  • Per summary of product characteristics.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724958     History of Changes
Other Study ID Numbers: P04052
First Posted: July 30, 2008    Key Record Dates
Results First Posted: October 26, 2011
Last Update Posted: October 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents