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Remicade Infusion Management Program

Remicade Infusion Management Program

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00723905
Acronym
RemiTRAC
Enrollment
1630
Registered
2008-07-29
Start date
2005-08-31
Completion date
2012-10-31
Last updated
2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid, Crohn Disease

Keywords

Crohn's Disease, Rheumatoid Arthritis

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.

Interventions

None listed

Sponsors

Janssen Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Type and frequency of infusion reactionsUp to 7 years
Pre-infusion treatments and efficacyUp to 7 years
Infusion reaction management approachesUp to 7 years
The number of subjects with adverse eventsUp to 7 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026