Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-02-08 @ 9:43 PM
Study NCT ID:
NCT01593332
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2012-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-05', 'studyFirstSubmitDate': '2012-01-07', 'studyFirstSubmitQcDate': '2012-05-05', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in 28-joint disease activity index( DAS28)', 'timeFrame': 'Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.', 'description': 'disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)'}, {'measure': 'Change in European league against rheumatism(EULAR) response criteria', 'timeFrame': 'Change in EULAR 2,16,24 weeks'}], 'secondaryOutcomes': [{'measure': 'Rituximab side effects', 'timeFrame': '0,2,16,24 weeks', 'description': 'side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rituximab', 'Rheumatoid arthritis', 'Biologics', 'Anti-tumour necrosis factor', 'Disease-modifying anti-rheumatic drugs', 'DAS28', 'European League Against Rheumatism response'], 'conditions': ['DMARD Resistant Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1987 ACR criteria for classification of RA\n* Positive for rheumatoid factor(RF)\n* Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 \\> 3/2\n* Patients with active, resistant RA who didn't receive anti TNF agents.\n\nExclusion Criteria:\n\n* Patient with hypogammaglobulinemia\n* Patient with congestive heart failure (classIV)\n* Active current bacterial,viral,fungal,myocardial or other infections\n* Chronic hepatitis B or hepatitis C carriers\n* History of severe allergic reaction to human,humanized or murine monoclonal antibodies\n* History of malignancies\n* Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease."}, 'identificationModule': {'nctId': 'NCT01593332', 'briefTitle': 'Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '87549'}, 'secondaryIdInfos': [{'id': '87549', 'type': 'OTHER', 'domain': 'DEPUTY OF RESEARCH OF MASHHAD UNIVERSITY OF MEDICAL SCIENCES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab', 'interventionNames': ['Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera'], 'description': 'two 500 mg rituximab infusions 2 weeks apart', 'armGroupLabels': ['Methotrexate', 'Rituximab']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera'], 'description': '500mg,two times with two weeks interval', 'armGroupLabels': ['Methotrexate', 'Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mashhad', 'state': 'Khorasan Razavi', 'country': 'Iran', 'facility': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'Kamila Hashemzadeh', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}