CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 234 enrolled
Drug / intervention
Infliximab +1 moredrug
Likely dose
Infliximab 3 mgfrom 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/NCT00896168
NCT00896168Phase 4Completed
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A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis

Xian-Janssen Pharmaceutical Ltd.·interventional·Posted May 11, 2009·Updated Sep 13, 2013

In Brief

A Phase 4 clinical trial evaluating Infliximab and Methotrexate for Arthritis, Rheumatoid. Completed, enrolled 234 participants.

Detailed Summary

The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.

Study Details

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

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2009
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.1 years ago

Interventions

Infliximabdrug

Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.

Methotrexatedrug

MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.