Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 5:33 AM
Study NCT ID:
NCT01338103
Status:
UNKNOWN
Last Update Posted:
2011-05-02
First Post:
2011-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-29', 'studyFirstSubmitDate': '2011-04-17', 'studyFirstSubmitQcDate': '2011-04-17', 'lastUpdatePostDateStruct': {'date': '2011-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete or partial remission off treatment (based on the consensus statement for pemphigus)', 'timeFrame': '6 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pemphigus', 'Rituximab', 'Cylex'], 'conditions': ['Pemphigus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Pemphigus patients with moderate-severe disease\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Woman of reproductive age not using birth control measures.\n3. Prior severe allergy or anaphylaxis with a human monoclonal antibody\n4. Heart failure\n5. Unstable angina or ischemic heart disease\n6. Uncontrolled arrhythmia\n7. HIV positive\n8. Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.\n9. Severe dementia or a psychiatric illness\n10. Active acute infection'}, 'identificationModule': {'nctId': 'NCT01338103', 'briefTitle': 'Treatment of Pemphigus Patients With Rituximab 1000mgX2 and Assessment of Immune Status Via Cylex', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test', 'orgStudyIdInfo': {'id': '5474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': 'intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Daniel Mimouni, MD', 'role': 'CONTACT'}], 'facility': 'Bullous diseases clinic, Department of dermatology, Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Daniel Mimouni, MD', 'role': 'CONTACT', 'phone': '972-3-9376658'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leumit Health Services', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Daniel Mimouni MD', 'oldOrganization': 'Rabin Medical Center, Department of Dermatology'}}}}