Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT00753103
Status:
COMPLETED
Last Update Posted:
2008-09-16
First Post:
2008-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-Cytokine Therapy for Vasculitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014890', 'term': 'Granulomatosis with Polyangiitis'}, {'id': 'D055953', 'term': 'Microscopic Polyangiitis'}, {'id': 'D014657', 'term': 'Vasculitis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'D010951', 'term': 'Plasma Exchange'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'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': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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'}, {'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010956', 'term': 'Plasmapheresis'}, {'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-15', 'studyFirstSubmitDate': '2008-09-15', 'studyFirstSubmitQcDate': '2008-09-15', 'lastUpdatePostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)', 'timeFrame': '0, 6, 10, 14, 26, 39 and 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Weeks 2, 6, 10, 14, 26, 39, 52'}, {'measure': 'Vasculitis Damage Index Score', 'timeFrame': 'Weeks 0, 14, 26, 39, 52'}, {'measure': 'Renal function', 'timeFrame': 'Weeks 0, 2, 6, 10, 14, 26, 39, 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infliximab', 'Vasculitis', 'antitnf monoclonal antibody'], 'conditions': ["Wegener's Granulomatosis", 'Renal Limited Vasculitis', 'Microscopic Polyangiitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis.', 'detailedDescription': 'Anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis is a life-threatening systemic inflammatory autoimmune disease. Current treatment regimes using corticosteroids and cyclophosphamide have improved patient survival but are associated with treatment associated morbidity and mortality. Tumour necrosis factor alpha (TNF) is a proinflammatory cytokine which has been implicated in the pathogenesis of ANCA vasculitis. Anti-TNF therapies have been used successfully in the management of other inflammatory autoimmune diseases. This phase II cohort study has been designed to investigate the safety and efficacy of anti-TNF monoclonal antibody (Infliximab) therapy for patients with ANCA associated vasculitis when used in addition to standard immunosuppressive therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's granulomatosis, microscopic polyangiitis, renal limited vasculitis)\n\nExclusion Criteria:\n\n* Active infection\n* Malignancy\n* Pregnancy\n* Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease"}, 'identificationModule': {'nctId': 'NCT00753103', 'acronym': 'ACTIVE', 'briefTitle': 'Anti-Cytokine Therapy for Vasculitis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Birmingham NHS Foundation Trust'}, 'officialTitle': 'Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis', 'orgStudyIdInfo': {'id': 'RRK2031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy', 'interventionNames': ['Biological: Infliximab', 'Drug: Cyclophosphamide', 'Drug: Prednisolone', 'Drug: Azathioprine', 'Drug: Mycophenolate mofetil', 'Drug: Methylprednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Prednisolone', 'Drug: Azathioprine', 'Procedure: Plasma exchange', 'Drug: Mycophenolate mofetil', 'Drug: Methylprednisolone']}], 'interventions': [{'name': 'Infliximab', 'type': 'BIOLOGICAL', 'otherNames': ['Remicade'], 'description': '5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study', 'armGroupLabels': ['1']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Daily oral 2 mg/kg or pulsed intravenous 15mg/kg every 2-3 weeks for 3-6 months (until patient has been in remission for 3 months).', 'armGroupLabels': ['1', '2']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Daily oral 1mg/kg tapered over 12 months', 'armGroupLabels': ['1', '2']}, {'name': 'Azathioprine', 'type': 'DRUG', 'description': 'Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.', 'armGroupLabels': ['1', '2']}, {'name': 'Plasma exchange', 'type': 'PROCEDURE', 'description': 'Additional therapy for patients with severe vasculitis (creatinine \\> 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.', 'armGroupLabels': ['2']}, {'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'description': 'Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.', 'armGroupLabels': ['1', '2']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'description': '500 mg intravenous infusion daily for three days at lead physicians discretion.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Lorraine Harper, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Birmingham NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Lorraine Harper', 'oldOrganization': 'University Hospitals Birmingham NHS Foundation Trust/University of Birmingham'}}}}