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
  Purpose

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 Intervention
Crohn's Disease
Biological: Infliximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 348
Study Start Date: December 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

This study population was chosen from a non-probability sample

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724958     History of Changes
Other Study ID Numbers: P04052
Study First Received: July 25, 2008
Results First Received: July 13, 2011
Last Updated: October 7, 2014
Health Authority: Austria: No HA submission required

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014