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Remicade Safety Line (Study P03236)(COMPLETED)

NCT00748826 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 576

Last updated 2015-09-03

Study results available
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Summary

The goal of this study is to implement instruments that would increase the treating physician's awareness of the necessary tuberculosis screening when starting a new patient on infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying preparations, including methotrexate.

Conditions

  • Arthritis, Rheumatoid

Interventions

BIOLOGICAL

Infliximab

Patients with active rheumatoid arthritis (RA) confirmed with American College of Rheumatology (ACR) criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of Infliximab therapy with additional infusions of 5 mg/kg at week 2

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748826 on ClinicalTrials.gov