Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid

Completed

• Conditions: Bullous Pemphigoid
• Interventions: Other: Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9

• Registration Number: NCT02883894
• Lead Sponsor: CHU de Reims

Brief Summary

Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin in European countries, including France.

Immunologically, BP is characterized by the production of autoantibodies directed against two major components of the hemidesmosome, BP180 and BP230.

The anti-BP180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its serum level at diagnosis have been correlated with disease activity. The anti-BP230 autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis did not correlate with disease activity.

Up to now, no clinical or immunologic factors have been identified to predict outcome of patients with good or poor prognosis bullous pemphigoid as defined by long complete remission off therapy and recurrent disease requiring maintenance therapy for years. The usefulness of BP180 or BP230 ELISA scores for monitoring BP patients during treatment also remains unclear.

Detailed Description

Aim of the study were :

To study association between the serum level of cytokines (IL-17 and IL-23) and of the protease MMP-9 and the relapse of bullous pemphigoid.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2012-04
• Study Completion: 2014-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-25
• Last Update Submitted: 2016-08-25
• Study First Posted: 2016-08-30
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients with bullous pemphigoid
• patients not yet receiving treatment for bullous pemphigoid
• aged > 18 years

Exclusion Criteria

• Patients with relapse of bullous pemphigoid

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bullous pemphigoid	Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9	Patients with bullous pemphigoid.

Primary Outcome Measures

Name	Time	Method
Relapse of bullous pemphigoid.	Month 12	The relapse of bullous pemphigoid is defined as he reappearance of at least 3 new daily blisters along with pruritus and/or erythematous, eczematous or urticarial plaques

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France