Remicade® Crohn's Disease Registry Across Canada (Study P02793AM2)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00755937

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. 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

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Infliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Remicade^TM Treatment Registry Across Canada in Crohn's Disease

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

To follow up on efficacy parameters in Canadian subjects treated with Remicade. [ Time Frame: From baseline, evaluations are conducted at 2 months, 6 months and every 6 months thereafter. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To follow up on safety parameters in Canadian subjects treated with Remicade [ Time Frame: From baseline, evaluations are conducted at 2 months, 6 months and every 6 months thereafter. ] [ Designated as safety issue: Yes ]
To provide expanded data to healthcare providers and hospitals to estimate and support appropriate use of Remicade. [ Time Frame: 2-4 times a year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	556
Study Start Date:	February 2002
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cohort 1 Crohn's disease patients receiving Remicade per Product Monograph.	Other: Data collection post infusion 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^TM (patient is naïve to Remicade^TM at the time of registration); AND,
Patient is a good candidate to receive Remicade^TM as per the PM; 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:

Not specified in the protocol; as per PM

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02793
Study First Received:	August 26, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00755937
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Digestive System Diseases
Infliximab
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 13, 2009