Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-02 @ 3:41 AM
Study NCT ID:
NCT00363350
Status:
COMPLETED
Last Update Posted:
2009-02-24
First Post:
2006-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab Treatment in Sjogren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-23', 'studyFirstSubmitDate': '2006-08-10', 'studyFirstSubmitQcDate': '2006-08-10', 'lastUpdatePostDateStruct': {'date': '2009-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stimulated whole salivary flow rate', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'Functional parameters', 'timeFrame': '48 weeks'}, {'measure': 'Laboratory parameters', 'timeFrame': '48 weeks'}, {'measure': 'Subjective parameters', 'timeFrame': '48 weeks'}, {'measure': 'Histological/Molecular parameters', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'conditions': ["Sjogren's Syndrome"]}, 'referencesModule': {'references': [{'pmid': '16142737', 'type': 'BACKGROUND', 'citation': "Pijpe J, van Imhoff GW, Spijkervet FK, Roodenburg JL, Wolbink GJ, Mansour K, Vissink A, Kallenberg CG, Bootsma H. Rituximab treatment in patients with primary Sjogren's syndrome: an open-label phase II study. Arthritis Rheum. 2005 Sep;52(9):2740-50. doi: 10.1002/art.21260."}, {'pmid': '20131246', 'type': 'DERIVED', 'citation': "Meijer JM, Meiners PM, Vissink A, Spijkervet FK, Abdulahad W, Kamminga N, Brouwer E, Kallenberg CG, Bootsma H. Effectiveness of rituximab treatment in primary Sjogren's syndrome: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Apr;62(4):960-8. doi: 10.1002/art.27314."}]}, 'descriptionModule': {'briefSummary': 'This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.', 'detailedDescription': 'Study design:\n\nphase II trial\n\nStudy objective:\n\nevaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS\n\nNumber of participating centres:\n\n1\n\nDuration:\n\nfollow-up 48 weeks\n\nStudy medication:\n\n2 infusions on day 1 and day 15 rituximab infusions (1000 mg) or placebo infusions intravenous infusion of 100 mg of methylprednisolone before infusion of rituximab (or the placebo for rituximab), together with 60 mg per day of oral prednisone on days 2, 3, 16 and 17, 30 mg per day on days 4, 5, 18 and 19 and 15 mg per day on days 6 and 20\n\nPrimary objective/endpoint:\n\nstimulated salivary gland function (stimulated submandibular/sublingual and parotid saliva)\n\nSecondary objectives/endpoint:\n\nFunctional parameters Laboratory parameters Subjective parameters Histological/Molecular parameters\n\nNumber of subjects:\n\n30 patients with primary SS (20 patients rituximab treatment, 10 patients placebo)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stimulated whole saliva secretion ≥ 0,15 ml/min\n* Male or female \\> 18 years\n* Primary SS according to the revised European - U.S. criteria(22)\n* Positive autoantibodies (IgM-Rf \\> 10 and SS-A and/or SS-B)\n* Parotid gland biopsy (paraffine material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago)\n* Use of reliable method of contraception during the study\n* Written informed consent\n\nExclusion Criteria:\n\n* The presence of any other connective tissue disease\n* Preceding treatment with anti-TNF or other monoclonal antibodies\n* Use of prednisone, hydroxychloroquine less than 1 month ago\n* Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than 0,5 year ago\n* Serum creatine \\> 2.8 mg/dl (250 micromol/l)\n* ASAT or ALAT outside 1.5 x upper normal range of the laboratory\n* Hb \\< 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females\n* Neutrophil granulocytes less than 0.5 x 109/l\n* Platelet count less then 50 x 109/l\n* Positive pregnancy test or breast-feeding\n* History of alcohol or drug abuse\n* Serious infections\n* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study\n* History of any malignancy with the exception of completely resected basal cell carcinoma of the skin'}, 'identificationModule': {'nctId': 'NCT00363350', 'briefTitle': "Rituximab Treatment in Sjogren's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': "Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial", 'orgStudyIdInfo': {'id': 'METc2005.229'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rituximab (anti-CD20)', 'type': 'DRUG', 'otherNames': ['Mabthera'], 'description': '2 infusions of 1000 mg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700 RB', 'city': 'Groningen', 'state': 'Provincie Groningen', 'country': 'Netherlands', 'facility': 'University Medical Centre Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Jiska Meijer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'H Bootsma', 'oldOrganization': 'University Medical Centre Groningen'}}}}