Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid

NCT01559155 | Terminated

• 2 other identifiers: LOCAL/2011/PS-022012-A00180-43
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.

Conditions

Pemphigoid, Bullous; Pemphigus; Lupus Erythematosus, Cutaneous

Keywords

proteasomes; proteasome concentration; disease activity; proteolytic activity; autoantibodies; proteasome autoantibody

Outcome Measures

Primary Outcomes (1)

• Plasmatic concentration of anti-proteasome autoantibodies (ng/ml)

  baseline

Secondary Outcomes (18)

• the daily number of new lesions

  baseline

• Presence/absence of mucosal disease

  baseline

• Disease duration (weeks)

  baseline

• % surface area

  baseline

• Puritis score

  baseline

Study Arms (3)

Bullous pemphigoid

Patients in this cohort are newly diagnosed (or have not started treatment) with bullous pemphigoid

Other bullous-like auto-immune

Patients in this cohort are newly diagnosed (or have not started treatment) with pemphigus (15 patients) or cutaneous lupus (15 patients)

Control group

Patients in this cohort are hospitalized at the Nîmes University Hospital, and have no history of autoimmune, inflammatory or neoplastic disease. Patients are matched for age and sex with patients in the bullous pemphigoid cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of three groups: (1) 50 patients with newly diagnosed (untreated) bullous pemphigoid, (2) 50 control patients matched for age and sex with the previous group and (3) 30 patients with other dermatological auto-immune disease (15 pemphigus + 15 cutaneous lupus).

You may qualify if:

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is not taking systemic treatment
• The patient has not been treated with topical steroids for more than 15 days.
• For the bullous pemphigoid group:
• clinical signs: erythematous-based lesions, especially on flexion areas of the arms and legs, not afflicting mucous membranes, and without atrophic scaring
• histology: without epidermal acantholysis
• For the pemphigus group:
• patient with pemphigus
• For the lupus group:
• systemic lupus patients: presence of the 4 diagnostic criteria for systemic lupus erythematosus as defined by the American College of Rheumatology (amended 1997)
• or characteristics of subacute cutaneous lupus: clinical, histological and immunological (anti-SSa)
• or clinical and histological characteristics of chronic lupus
• For the control group:
• hospitalized patients with no history of auto-immune, inflammatory or evolving neoplastic disease

You may not qualify if:

• The patient is participating in another study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• For patients with bullous pemphigoid, pemphigus or lupus:
• The patient is taking systemic treatment
• The patient has been taking topical steroids for more than 15 days.
• For the controls:
• autoimmune disease
• inflammatory disease
• evolving neoplastic disease
• surgery during the last 6 months

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

All left over plasma samples will be incorporated into the biological collection at the Nîmes University Hospital.

MeSH Terms

Conditions

Pemphigoid, Bullous; Pemphigus; Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre Stoebner, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: November 5, 2013
• Primary Completion: June 9, 2015
• Study Completion: June 9, 2015
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

FR (1)