Remicade Infusion Management Program (RemiTRAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Inc.
ClinicalTrials.gov Identifier:
NCT00723905
First received: July 25, 2008
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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 Phase
Crohn Disease
Arthritis, Rheumatoid
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Infusion Management Program

Resource links provided by NLM:


Further study details as provided by Janssen Inc.:

Primary Outcome Measures:
  • Type and frequency of infusion reactions [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Pre-infusion treatments and efficacy [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • Infusion reaction management approaches [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • The number of subjects with adverse events [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

Enrollment: 1630
Study Start Date: August 2005
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Janssen Inc.
ClinicalTrials.gov Identifier: NCT00723905     History of Changes
Other Study ID Numbers: CR100746, P04466
Study First Received: July 25, 2008
Last Updated: January 14, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014