NCT00755937 - Remicade® Crohn's Disease Registry Across Canada (Study P02793) | Crick | Crick

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

N/ATerminatedNCT00755937

Merck Sharp & Dohme LLC556 enrolled

Overview

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®.

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

Study Type

OBSERVATIONAL

Enrollment

556

Conditions

Crohn's Disease

Interventions

Data collection post infusionOTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From 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.

Time frame: 12 months after baseline

Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From 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.

Time frame: 24 months after baseline

Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From 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.

Time frame: 36 months after baseline

Clinical Remission at 12 Months (CDAI <= 150 Points).

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.

Time frame: 12 months after baseline

Clinical Remission at 24 Months (CDAI <= 150 Points).

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.

Data from ClinicalTrials.gov

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