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

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Crohn's Disease

Treatments: Other: Data collection post infusion

Study type: Observational

Funder types: Industry

Identifiers

NCT00755937

P02793

Details and patient eligibility

About

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®.

Full description

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

Enrollment: 556 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

556 participants in 1 patient group

Subjects receiving Remicade

Description:

Crohn's disease subjects receiving Remicade® per Product Monograph.

Treatment:

Other: Data collection post infusion