Remicade® Crohn's Disease Registry Across Canada (Study P02793) (RemiTRAC®)

This study has been terminated.
(Satisfied a post-marketing commitment to Canadian Health Authorities.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00755937
First received: August 26, 2008
Last updated: April 25, 2014
Last verified: April 2014
  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 Merck Sharp & Dohme Corp.:

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 ]
    CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.

  • 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 ]
    CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.

  • 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 ]
    CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.

  • Clinical Remission at 12 Months (CDAI <= 150 Points). [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
    CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.

  • Clinical Remission at 24 Months (CDAI <= 150 Points). [ Time Frame: 24 months after baseline ] [ Designated as safety issue: No ]
    CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.

  • Clinical Remission at 36 Months (CDAI <= 150 Points). [ Time Frame: 36 months after baseline ] [ Designated as safety issue: No ]
    CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is < 150, and moderate to severe disease ranges from 220 to 450.


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
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: NCT00755937     History of Changes
Other Study ID Numbers: P02793
Study First Received: August 26, 2008
Results First Received: September 29, 2008
Last Updated: April 25, 2014
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 July 22, 2014