Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-04-09 @ 7:27 AM
Study NCT ID:
NCT02102594
Status:
TERMINATED
Last Update Posted:
2019-12-03
First Post:
2014-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-29', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in disease specific antibody titers after application of Bortezomib', 'timeFrame': '6 months after end of therapy (6 weeks) compared to baseline (before therapy)', 'description': 'Change in disease specific antibody titers (anti-ACh for myasthenia gravis, anti-dsDNA for systemic lupus erythematosus, anti-ACPA for rheumatoid arthritis) 6 months after end of Bortezomib therapy (duration 6 weeks) compared to baseline (before therapy).'}], 'secondaryOutcomes': [{'measure': 'Change in disease specific antibody titer after Bortezomib application', 'timeFrame': 'at regular intervals up to 30 weeks compared to baseline', 'description': 'Change in disease specific antibody titer after Bortezomib application (except at time point 6 months after end of therapy = primary outcome measure)'}, {'measure': 'Change in quality of life (Qol score)', 'timeFrame': 'at regular intervals up to 30 weeks compared to baseline'}, {'measure': 'Change in Activities of Daily Living (Adl score)', 'timeFrame': 'at regular intervals up to 30 weeks compared to baseline'}, {'measure': 'change in dose of immunosuppressive co-medication', 'timeFrame': 'at regular intervals up to 30 weeks compared to baseline'}, {'measure': 'Change in titers of protective antibodies (e.g. measles)', 'timeFrame': 'at regular intervals up to 30 weeks compared to baseline', 'description': 'Change in titers of protective antibodies against measles virus, rubella virus, varicella zoster virus, pneumococcus, cytomegalovirus'}, {'measure': 'Change in number of antibody producing plasmablasts/cells', 'timeFrame': 'at regular intervals up to 30 weeks compared to baseline', 'description': 'Change in number of antibody producing plasmablasts/cells in peripheral blood'}, {'measure': 'Change in concentration of soluble mediators (e.g. IL-6)', 'timeFrame': 'at regular intervals up to 30 weeks compared to baseline', 'description': 'Change in concentration of soluble mediators (e.g. IL-6) in peripheral blood'}, {'measure': 'need for hospitalisation', 'timeFrame': 'at regular intervals up to 30 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'Systemic Lupus Erythematosus', 'Rheumatoid Arthritis', 'proteasome inhibitor', 'Bortezomib', 'Velcade', 'antibody-mediated autoimmune disease'], 'conditions': ['Myasthenia Gravis', 'Systemic Lupus Erythematosus', 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '26971655', 'type': 'BACKGROUND', 'citation': 'Kohler S, Losen M, Alexander T, Hiepe F, Meisel A. Myasthenia gravis: subgroup classifications. Lancet Neurol. 2016 Apr;15(4):356-7. doi: 10.1016/S1474-4422(16)00033-8. No abstract available.'}, {'pmid': '30696682', 'type': 'BACKGROUND', 'citation': 'Kohler S, Marschenz S, Grittner U, Alexander T, Hiepe F, Meisel A. Bortezomib in antibody-mediated autoimmune diseases (TAVAB): study protocol for a unicentric, non-randomised, non-placebo controlled trial. BMJ Open. 2019 Jan 28;9(1):e024523. doi: 10.1136/bmjopen-2018-024523.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to investigate the application of proteasome inhibitor Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is that the proteasome inhibition will lead to reduced antibody titers and improved clinical outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '(main) Inclusion Criteria:\n\n* age 18 - 75 years at screening\n* ability to give written consent, informed written consent\n* negative pregnancy test at screening\n* therapy-refractory Myasthenia Gravis (generalized) or Systemic Lupus Erythematosus or Rheumatoid Arthritis\n\n(main) Exclusion Criteria:\n\n* Belimumab therapy within the last 6 months\n* B-cell-depletion therapy within the last 9 months\n* heart or kidney insufficiency\n* known intolerability to Bortezomib\n* participation in another interventional trial within the last 3 months\n* liver cirrhosis\n* preexistent sensory or motor polyneuropathy ≥ degree 2 (NCI CTC AE criteria), within 14 days before screening\n* hints on clinically apparent herpes zoster reactivation\n* active systemic infection, or viral infection (CMV, EBV) within last 6 month before screening\n* serologically active hepatitis B and /or C, known HIV infection\n* tumor disease currently or within last 5 years\n* clinically relevant liver, kidney or bone marrow function disorder\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT02102594', 'acronym': 'TAVAB', 'briefTitle': 'Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)', 'orgStudyIdInfo': {'id': 'TAVAB'}, 'secondaryIdInfos': [{'id': '2013-005362-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bortezomib (Velcade)', 'interventionNames': ['Drug: Bortezomib']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'Bortezomib will be subcutaneously applicated in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle.', 'armGroupLabels': ['Bortezomib (Velcade)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumathology', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Meisel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center'}, {'name': 'Falk Hiepe, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology)', 'class': 'UNKNOWN'}, {'name': 'NeuroCure Clinical Research Center, Charite, Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Andreas Meisel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}