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Remicade Infusion Management Program (RemiTRAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00723905
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Janssen Inc. 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 or disease Phase
Crohn Disease Arthritis, Rheumatoid Phase 4

Study Design

Study Type : Observational
Actual Enrollment : 1630 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Infusion Management Program
Study Start Date : August 2005
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Type and frequency of infusion reactions [ Time Frame: Up to 7 years ]
  2. Pre-infusion treatments and efficacy [ Time Frame: Up to 7 years ]
  3. Infusion reaction management approaches [ Time Frame: Up to 7 years ]
  4. The number of subjects with adverse events [ Time Frame: Up to 7 years ]

Eligibility Criteria

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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723905


Locations
Canada, Quebec
Montreal, Quebec, Canada
Canada
Pointe-Claire, Canada
Sponsors and Collaborators
Janssen Inc.
Investigators
Study Director: Janssen Inc. Clinical Trial Janssen Inc.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT00723905     History of Changes
Other Study ID Numbers: CR100746
P04466 ( Other Identifier: Janssen Inc. )
First Posted: July 29, 2008    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by Janssen Inc.:
Crohn's Disease, Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Crohn Disease
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents