CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 593 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/NCT00254982
NCT00254982Phase 3Completed
CompareCT.gov

An Open-Label Study to Determine Equivalence in Efficacy, Organ Safety and Systemic Tolerability Between Infliximab in GROUP I ("High Need") and GROUP II ("Low Need") Patients Suffering From Chronic Plaque Psoriasis (Psoriasis Vulgaris)

Merck Sharp & Dohme LLC·interventional·Posted Nov 17, 2005·Updated Oct 12, 2015

In Brief

A Phase 3 clinical trial evaluating Infliximab for Psoriasis. Completed, enrolled 593 participants.

Detailed Summary

This is an open-label, multicenter, parallel-group comparison study of the efficacy, safety, and tolerability of infliximab therapy in adult patients suffering from chronic plaque psoriasis (psoriasis vulgaris). Patients will be assigned to GROUP I ("high need") or GROUP II ("low-need") by the investigator according to their previous psoriasis treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
Countries--
CollaboratorsEssex Pharma GmbH, Centocor, Inc.

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 17, 2005
Enrollment StartAug 1, 2005
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.6 years ago

Interventions

Infliximabbiological

Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.