Remicade Infusion Management Program (Study P04466) - Full Text View

Sponsors and Collaborators:	Schering-Plough Centocor, Inc.
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00723905

Purpose

Schering Canada plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.

Condition	Intervention
Crohn Disease Rheumatoid Arthritis	Biological: Infliximab

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Rheumatoid Arthritis

Drug Information available for: Infliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Remicade Infusion Management Program

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

To accurately define the types and frequency of infusion reactions. [ Time Frame: At each infusion following treatment administration (as per product monograph) ] [ Designated as safety issue: Yes ]
To collect information on pre-infusion treatments and their efficacy. [ Time Frame: At each infusion following treatment administration (as per product monograph) ] [ Designated as safety issue: No ]
To collect information on infusion reaction management approaches [ Time Frame: At each infusion following treatment administration (as per product monograph) ] [ Designated as safety issue: Yes ]
To follow up on safety parameters in subjects treated with infliximab [ Time Frame: At each infusion following treatment administration (as per product monograph) ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	567
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Infliximab The data captured and reported in this registry will reflect a "real world" approach to the treatment of Rheumatoid Arthritis and Crohn's Disease with infliximab.	Biological: Infliximab Not specified in protocol

Detailed Description:

This study population was chosen from a non-probability sample.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The data captured and reported in this registry will reflect a "real world" approach to the treatment of Rheumatoid Arthritis and Crohn's Disease with infliximab.

Criteria

Inclusion Criteria:

Subject is a good candidate to receive infliximab as per the Product Monograph.
Subject is prescribed infliximab by an appropriate physician.
Subject receives infusion in a community infusion centre.
Subject has signed the approved consent form.

Exclusion Criteria:

Not specified in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723905

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Canada
Coordinating Location	Recruiting
Pointe-Claire, Canada

Sponsors and Collaborators

Schering-Plough

Centocor, Inc.

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04466
Study First Received:	July 25, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00723905 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Anti-Inflammatory Agents
Crohn's Disease
Autoimmune Diseases
Infliximab
Gastrointestinal Diseases
Ileitis
Enteritis
Joint Diseases
Arthritis, Rheumatoid
Inflammatory Bowel Diseases

Rheumatic Diseases
Intestinal Diseases
Ileal Diseases
Digestive System Diseases
Musculoskeletal Diseases
Arthritis
Crohn Disease
Connective Tissue Diseases
Antirheumatic Agents
Gastroenteritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immune System Diseases
Infliximab
Gastrointestinal Diseases
Ileitis
Enteritis
Joint Diseases
Gastrointestinal Agents
Arthritis, Rheumatoid
Inflammatory Bowel Diseases
Rheumatic Diseases

Intestinal Diseases
Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Crohn Disease
Connective Tissue Diseases
Antirheumatic Agents
Gastroenteritis
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009