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Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid


N/A
18 Years
N/A
Not Enrolling
Both
Pemphigoid, Bullous, Pemphigus, Lupus Erythematosus, Cutaneous

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Trial Information

Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid


The secondary objectives of this study are:

To compare the following parameters between the 3 groups:

- plasmatic proteasome concentrations

- plasmatic proteasome proteolytic activity

To explore the potential relationships between:

- plasmatic proteasome concentrations

- plasmatic proteasome proteolytic activity

- plasmatic anti-proteasome auto-antibody concentrations

- measures of disease severity for dermatological auto-immune diseases

To characterize plasmatic anti-proteasome auto-antibodies in patients suffering from bullous
pemphigoide and other dermatological auto-immune diseases (other bullous auto immune
diseases: pemphigus, cutaneous lupus, ...).

To characterize the expression and the activity of proteasomes in skin samples, in plasma
and in circulating mononuclear cells in patients with bullous pemphigoide.


Inclusion Criteria:



- The patient must have given his/her informed and signed consent

- The patient must be insured or beneficiary of a health insurance plan

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

- patient has not started treatment

For the pemphigus group:

- patient with pemphigus

- patient has not started treatment

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

- the patient has not started treatment

For the control group:

- hospitalized patients with no history of auto-immune, inflammatory or evolving
neoplastic disease

Exclusion Criteria:

- The patient is participating in another study

- The patient is in an exclusion period determined by a previous 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 has started treatment for his/her autoimmune disease

For the controls:

- autoimmune disease

- inflammatory disease

- evolving neoplastic disease

- surgery during the last 6 months

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

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

Outcome Time Frame:

baseline

Safety Issue:

No

Principal Investigator

Pierre Stoebner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nîmes

Authority:

France: Committee for the Protection of Personnes

Study ID:

LOCAL/2011/PS-02

NCT ID:

NCT01559155

Start Date:

July 2013

Completion Date:

July 2015

Related Keywords:

  • Pemphigoid, Bullous
  • Pemphigus
  • Lupus Erythematosus, Cutaneous
  • proteasomes
  • proteasome concentration
  • disease activity
  • proteolytic activity
  • autoantibodies
  • proteasome autoantibody
  • Autoimmune Diseases
  • Lupus Erythematosus, Cutaneous
  • Pemphigoid, Bullous
  • Pemphigus
  • Lupus Erythematosus, Systemic

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