Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-02 @ 11:33 AM
Study NCT ID:
NCT00656656
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2008-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D001379', 'term': 'Azathioprine'}], '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'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'detlef.zillikens@uksh.de', 'phone': '+49-451-500-41500', 'title': 'Prof. Dr. Detlef Zillikens', 'organization': 'University of Lübeck'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Immunoadsorption/Dexamethasone/Rituximab', 'description': 'Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil\n\nProtein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks\n\nRituximab: 1000 mg i.v. given twice at a 2-week interval\n\nDexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks\n\nAzathioprine: 2.5 mg/kg body weight daily p.o.\n\nMycophenolate mofetil 2 g/d p.o.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'extensive herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Achieving a Short- and Long-term Remission of Pemphigus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immunoadsorption/Dexamethasone/Rituximab', 'description': 'Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil\n\nProtein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks\n\nRituximab: 1000 mg i.v. given twice at a 2-week interval\n\nDexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks\n\nAzathioprine: 2.5 mg/kg body weight daily p.o.\n\nMycophenolate mofetil 2 g/d p.o.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 43 months', 'description': 'Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Experienced Side-effects of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Immunoadsorption/Dexamethasone/Rituximab', 'description': 'Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil\n\nProtein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks\n\nRituximab: 1000 mg i.v. given twice at a 2-week interval\n\nDexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks\n\nAzathioprine: 2.5 mg/kg body weight daily p.o.\n\nMycophenolate mofetil 2 g/d p.o.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 43 months', 'description': 'Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immunoadsorption/Dexamethasone/Rituximab', 'description': 'Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil\n\nProtein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks\n\nRituximab: 1000 mg i.v. given twice at a 2-week interval\n\nDexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks\n\nAzathioprine: 2.5 mg/kg body weight daily p.o.\n\nMycophenolate mofetil 2 g/d p.o.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Immunoadsorption/Dexamethasone/Rituximab', 'description': 'Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil\n\nProtein A Immunoadsorption: performed on 3 consecutive days every 3-4 weeks\n\nRituximab: 1000 mg i.v. given twice at a 2-week interval\n\nDexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days initially every 3 weeks\n\nAzathioprine: 2.5 mg/kg body weight daily p.o.\n\nMycophenolate mofetil 2 g/d p.o.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2008-04-07', 'resultsFirstSubmitDate': '2016-10-28', 'studyFirstSubmitQcDate': '2008-04-07', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-28', 'studyFirstPostDateStruct': {'date': '2008-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Achieving a Short- and Long-term Remission of Pemphigus', 'timeFrame': 'up to 43 months', 'description': 'Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Who Experienced Side-effects of Treatment', 'timeFrame': 'up to 43 months', 'description': 'Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pemphigus', 'rituximab', 'immunoadsorption', 'dexamethasone', 'treatment', 'management'], 'conditions': ['Pemphigus']}, 'descriptionModule': {'briefSummary': "Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of pemphigus confirmed by immunofluorescence and desmoglein ELISA.\n* Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.\n\nExclusion Criteria:\n\n* General condition too poor to tolerate immunoadsorption treatment.\n* Severe dementia or psychiatric disease.'}, 'identificationModule': {'nctId': 'NCT00656656', 'briefTitle': 'Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab', 'orgStudyIdInfo': {'id': 'Pemphigus-Luebeck'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Immunoadsorption/Dexamethasone/Rituximab', 'interventionNames': ['Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine']}], 'interventions': [{'name': 'Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine', 'type': 'DRUG', 'description': 'Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks\n\nRituximab: 1000 mg i.v. given twice at a 2-week interval\n\nDexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks\n\nAzathioprine: 2.5 mg/kg body weight daily p.o.', 'armGroupLabels': ['Immunoadsorption/Dexamethasone/Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23552', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Department of Dermatology, University of Luebeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Detlef Zillikens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, University of Luebeck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatologist', 'investigatorFullName': 'Michael Kasperkiewicz', 'investigatorAffiliation': 'University of Luebeck'}}}}