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

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ClinicalTrials.gov Identifier: NCT02883894
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Bullous Pemphigoid Other: Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9

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.


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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid
Study Start Date : November 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

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



Primary Outcome Measures :
  1. Relapse of bullous pemphigoid. [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with bullous pemphigoid.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883894


Locations
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France
Chu de Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims

Publications:
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02883894     History of Changes
Other Study ID Numbers: 176IR09
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases