CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 576 enrolled
Drug / intervention
Infliximabbiological
Likely dose
Infliximab 5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00748826
NCT00748826N/ACompleted
CompareCT.gov

Remicade Safety Line

Merck Sharp & Dohme LLC·observational·Posted Sep 9, 2008·Updated Sep 3, 2015

In Brief

An observational study evaluating Infliximab for Arthritis, Rheumatoid. Completed, enrolled 576 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2008
Enrollment StartAug 1, 2002
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 17.8 years ago

Interventions

Infliximabbiological

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