Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-02-20 @ 1:32 PM
Study NCT ID:
NCT02883894
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2016-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010391', 'term': 'Pemphigoid, Bullous'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D020381', 'term': 'Interleukin-17'}, {'id': 'D053759', 'term': 'Interleukin-23'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-25', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse of bullous pemphigoid.', 'timeFrame': 'Month 12', 'description': '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'}]}, 'conditionsModule': {'conditions': ['Bullous Pemphigoid']}, 'referencesModule': {'references': [{'pmid': '26656739', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin in European countries, including France.\n\nImmunologically, BP is characterized by the production of autoantibodies directed against two major components of the hemidesmosome, BP180 and BP230.\n\nThe 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.\n\nUp 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.', 'detailedDescription': 'Aim of the study were :\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with bullous pemphigoid.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with bullous pemphigoid\n* patients not yet receiving treatment for bullous pemphigoid\n* aged \\> 18 years\n\nExclusion Criteria:\n\n\\- Patients with relapse of bullous pemphigoid'}, 'identificationModule': {'nctId': 'NCT02883894', 'acronym': 'Cyto-PB', 'briefTitle': 'Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Reims'}, 'officialTitle': 'Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid', 'orgStudyIdInfo': {'id': '176IR09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bullous pemphigoid', 'description': 'Patients with bullous pemphigoid.', 'interventionNames': ['Other: Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9']}], 'interventions': [{'name': 'Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9', 'type': 'OTHER', 'armGroupLabels': ['bullous pemphigoid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51092', 'city': 'Reims', 'state': 'France', 'country': 'France', 'facility': 'Chu de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Reims', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}