Remicade® Crohn's Disease Registry Across Canada (Study P02793AM2)(COMPLETED) (RemiTRAC®)

This study has been terminated.
(Satisfied a post-marketing commitment to Canadian Health Authorities.)
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00755937
First received: August 26, 2008
Last updated: October 9, 2009
Last verified: October 2009
  Purpose

This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects with Crohn's disease being treated with Remicade® as per approved product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed experimental intervention and treatment with Remicade® is determined solely by the subject's physicians. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment of Crohn's disease with Remicade®.


Condition Intervention
Crohn's Disease
Other: Data collection post infusion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade® Treatment Registry Across Canada in Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline). [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
  • Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline). [ Time Frame: 24 months after baseline ] [ Designated as safety issue: No ]
  • Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline). [ Time Frame: 36 months after baseline ] [ Designated as safety issue: No ]
  • Clinical Remission at 12 Months (CDAI <= 150 Points). [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
  • Clinical Remission at 24 Months (CDAI <= 150 Points). [ Time Frame: 24 months after baseline ] [ Designated as safety issue: No ]
  • Clinical Remission at 36 Months (CDAI <= 150 Points). [ Time Frame: 36 months after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Serious Adverse Events [ Time Frame: Throughout study (up to 36 months) ] [ Designated as safety issue: No ]

Enrollment: 556
Study Start Date: February 2002
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects receiving Remicade
Crohn's disease subjects receiving Remicade® per Product Monograph.
Other: Data collection post infusion

Detailed Description:

Subjects will be selected for this registry using a non-probability sampling method.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primarily from community centers and some academic centers.

Criteria

Inclusion Criteria:

  • Patient was given the Patient Information Brochure; AND,
  • Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND,
  • Patient is a good candidate to receive Remicade® as per the product monograph; AND,
  • Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND,
  • Patient has signed the approved consent form.

Exclusion Criteria:

  • Per product monograph
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00755937     History of Changes
Other Study ID Numbers: P02793
Study First Received: August 26, 2008
Results First Received: September 29, 2008
Last Updated: October 9, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014