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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724958
First received: July 25, 2008
Last updated: October 7, 2014
Last verified: October 2014

July 25, 2008
October 7, 2014
December 2004
July 2010   (final data collection date for primary outcome measure)
  • Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    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).
Collect data on the real life dosing regimen of Remicade in patients with CD in the hospital and non-hospital setting. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00724958 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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).
  • Hospitalization rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

This study population was chosen from a non-probability sample

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects with active luminal and/or fistulizing CD who are treated with Remicade in the hospital and non-hospital setting.

Crohn's Disease
Biological: Infliximab
Not specified in the protocol.
Other Names:
  • Remicade
  • SCH 215596
Remicade
Subjects with active luminal and/or fistulizing CD in the hospital or non-hospital setting.
Intervention: Biological: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
348
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with active luminal and/or fistulizing CD.

Exclusion Criteria:

  • Per summary of product characteristics.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00724958
P04052
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Centocor, Inc.
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP