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

NCT02883894 | Completed

• 1 other identifier: 176IR09
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• Relapse of bullous pemphigoid.

  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

  Month 12

Study Arms (1)

bullous pemphigoid

Patients with bullous pemphigoid.

Other: Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9

Interventions

Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9 OTHER

bullous pemphigoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with bullous pemphigoid.

You may qualify if:

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

You may not qualify if:

• \- Patients with relapse of bullous pemphigoid

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

Location

Related Publications (1)

• Plee J, Le Jan S, Giustiniani J, Barbe C, Joly P, Bedane C, Vabres P, Truchetet F, Aubin F, Antonicelli F, Bernard P. Integrating longitudinal serum IL-17 and IL-23 follow-up, along with autoantibodies variation, contributes to predict bullous pemphigoid outcome. Sci Rep. 2015 Dec 14;5:18001. doi: 10.1038/srep18001.

  PMID: 26656739 BACKGROUND

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Blood Specimen Collection; Interleukin-17; Interleukin-23

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: August 30, 2016
• Study Start: November 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2014
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

FR (1)