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

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ClinicalTrials.gov Identifier: NCT00755937
Recruitment Status : Terminated (Satisfied a post-marketing commitment to Canadian Health Authorities.)
First Posted : September 19, 2008
Results First Posted : June 11, 2009
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment
Crohn's Disease Other: Data collection post infusion

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

Study Type : Observational
Actual Enrollment : 556 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade® Treatment Registry Across Canada in Crohn's Disease
Study Start Date : February 2002
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

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
Subjects receiving Remicade
Crohn's disease subjects receiving Remicade® per Product Monograph.
Other: Data collection post infusion



Primary Outcome Measures :
  1. 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 ]
    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.

  2. Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline). [ Time Frame: 24 months after baseline ]
    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.

  3. Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline). [ Time Frame: 36 months after baseline ]
    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.

  4. Clinical Remission at 12 Months (CDAI <= 150 Points). [ Time Frame: 12 months after baseline ]
    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.

  5. Clinical Remission at 24 Months (CDAI <= 150 Points). [ Time Frame: 24 months after baseline ]
    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.

  6. Clinical Remission at 36 Months (CDAI <= 150 Points). [ Time Frame: 36 months after baseline ]
    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 :
  1. Number of Serious Adverse Events [ Time Frame: Throughout study (up to 36 months) ]


Information from the National Library of Medicine

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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
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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00755937     History of Changes
Other Study ID Numbers: P02793
First Posted: September 19, 2008    Key Record Dates
Results First Posted: June 11, 2009
Last Update Posted: June 22, 2015
Last Verified: May 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