CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 660 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/NCT00779675
NCT00779675N/ACompleted

Real-World Assessment of Long-Term Infliximab Therapy for Psoriasis

Merck Sharp & Dohme LLC·observational·Posted Oct 24, 2008·Updated Nov 2, 2015

In Brief

An observational study evaluating Infliximab for Psoriasis. Completed, enrolled 660 participants.

Detailed Summary

This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 24, 2008
Enrollment StartOct 1, 2008
Primary CompletionOct 1, 2011
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.7 years ago

Interventions

Infliximabbiological

Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).