Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 5:14 AM
Study NCT ID:
NCT01299857
Status:
COMPLETED
Last Update Posted:
2012-09-13
First Post:
2011-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010392', 'term': 'Pemphigus'}], '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': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-12', 'studyFirstSubmitDate': '2011-02-17', 'studyFirstSubmitQcDate': '2011-02-17', 'lastUpdatePostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of relapse after 5 years of treatment', 'timeFrame': 'five years', 'description': 'Primary outcome measure is the evaluation of Rate of relapse after 5 years of treatment by rituximab for patient with pemphigus. The relapse is defined by the reappearance of mucous or cutaneous érosives lésions proved by histology and by direct immunofluorescence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pemphigus', 'Mabthéra (R)', 'B lymphocytes', 'desmogleines'], 'conditions': ['Pemphigus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the midterm clinical evaluation, biological parameters and immune reconstitution after Rituximab treatment for Pemphigus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18\n* consentment\n* patient treated with Rituximab and included in clinical trial n°2002/020/HP - NCT00213512 "Treatment of Patients Presenting Pemphigus With Anti CD20 (Mabthera)".\n\nExclusion Criteria:\n\n* age \\< 18\n* no consentment'}, 'identificationModule': {'nctId': 'NCT01299857', 'acronym': 'Suiviritux', 'briefTitle': 'Long-term Clinical and Biological Evaluation of Patients With Severe Forms of Pemphigus Treated by Rituximab', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'EVALUATION CLINIQUE ET BIOLOGIQUE A LONG TERME DES PATIENTS ATTEINTS DE FORMES SEVERES DE PEMPHIGUS TRAITES PAR LE RITUXIMAB', 'orgStudyIdInfo': {'id': '2009/141/HP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthéra'], 'description': '375mg/m2'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'state': 'Seine maritime,', 'country': 'France', 'facility': 'UH-Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Damien PICARD, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'dermatological department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}