CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Infliximab +1 moredrug
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/NCT00283712
NCT00283712Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Infliximab in Subjects With Pemphigus Vulgaris Receiving Prednisone

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 30, 2006·Updated Dec 6, 2017

In Brief

A Phase 2 clinical trial evaluating Infliximab and Placebo Comparator for Pemphigus. Completed, enrolled 20 participants across 4 sites.

Detailed Summary

Pemphigus vulgaris (PV) is a rare skin disorder that causes blistering of the skin and mucous membranes. Infliximab is a man-made antibody used to treat certain types of immune system disorders, including rheumatoid arthritis and Crohn's disease. This study will determine if infliximab given in combination with prednisone is a safe and effective treatment for adults with PV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPemphigus
CountriesUnited States
CollaboratorsAutoimmunity Centers of Excellence

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2006
Enrollment StartMar 1, 2006
Primary CompletionDec 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.4 years ago

Interventions

Infliximabdrug

Chimeric IgG monoclonal antibody that binds to TNF-alpha, generally used to treat Crohn's disease, given in a dosage of 5 mg/kg

Placebo Comparatorother

Placebo administered in place of infliximab for control group