Trial intelligence / Profile preview

Infliximab for Hidradenitis Suppurativa

NCT00795574Phase 2

Key facts

Status: Completed
Start: Jun 2005
Primary completion: Aug 2008
Countries: 1
Sponsor: Florida Academic Dermatology Centers
Modality: Monoclonal Antibodies

Drugs: infliximab
Conditions: hidradenitis suppurativa (HS)

Overview

Phase 2, randomised, double-blind trial in hidradenitis suppurativa (HS) comparing Infliximab with Placebo (2 arms). Primary endpoint: Hidradenitis Suppurativa Severity Index at 8 weeks. Started Jun 2005; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Infliximab
Infliximab 5mg/kg IV at weeks 0, 2, 6, then every 8 weeks
Placebo
Placebo IV at weeks 0, 2, 6, then crossover to Infliximab

Who it enrols

Adult patients with moderate to severe Hidradenitis Suppurativa for >1 year who have failed systemic retinoids and at least one course of antibiotics. Patients must not have active infections, history of malignancy within 5 years, or history of lymphoproliferative disease.

Endpoints

Primary

Hidradenitis Suppurativa Severity Index8 weeks

Secondary

Dermatology Life Quality Index8 weeks
Visual Analog Scale8 weeks
Physician Global Assessment8 weeks
Erythrocyte Sedimentation Rate8 weeks
C-Reactive Protein8 weeks

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