Remicade Infusion Management Program

NCT ID: NCT00723905

Last Updated: 2013-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1630 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn Disease Arthritis, Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Inc.

Locations

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Montreal, Quebec, Canada

Site Status

Pointe-Claire, , Canada

Site Status

Countries

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Canada

References

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Choquette D, Faraawi R, Chow A, Rodrigues J, Bensen WJ, Nantel F. Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry. J Rheumatol. 2015 Jul;42(7):1105-11. doi: 10.3899/jrheum.140538. Epub 2015 Jun 15.

Reference Type DERIVED
PMID: 26077415 (View on PubMed)

Other Identifiers

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P04466

Identifier Type: OTHER

Identifier Source: secondary_id

CR100746

Identifier Type: -

Identifier Source: org_study_id

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