Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-01 @ 1:22 PM
Study NCT ID:
NCT02024334
Status:
UNKNOWN
Last Update Posted:
2013-12-31
First Post:
2013-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], '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': 'D000077339', 'term': 'Leflunomide'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-25', 'studyFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2013-12-25', 'lastUpdatePostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'thirty percent changes in the ACR Pediatric core set of disease activity measures in at least three of the six response variables (ACR Pedi 30)', 'timeFrame': 'baseline, week 4, week 8, week 12', 'description': '6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR (Erythrocyte Sedimentation Rate), CHAQ (Childhood Health Assessment Questionnaire) score.'}], 'secondaryOutcomes': [{'measure': '50% and 70% changes in the ACR Pediatric core set of disease activity measures in at least three of the six response variables (ACR Pedi 30)', 'timeFrame': 'baseline, week 4, week 8, week 12', 'description': '6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR, CHAQ score.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['JIA', 'LEFLUNOMIDE', 'EFFICACY'], 'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of refractory juvenile idiopathic arthritis.\n\nPatients are randomly divided into two groups. In group 1 leflunomide and in group 2 placebos will be added to conventional treatment for three months. therapeutic responses will be evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4 weeks.', 'detailedDescription': '30 Patients(2-19 y) are randomly divided into two groups. In group 1 leflunomide will be added to conventional treatment, 5-20 mg daily based on weight.\n\nIn group 2 placebo will be prescribed as same as leflunomide. The course of treatment is 3 months. Every 4 weeks ACRped 30, 50, 70 should be determined to evaluate therapeutic response. Side effects of treatment will be assessed by physical examination and lab tests every 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* JIA based on ACR criteria\n* age between 2- 19 y\n* polyarticular, oligoarticular(\\> or = 3 active joints) or extended oligoarticular subtypes\n* resistance to conventional treatment\n\nExclusion Criteria:\n\n* pregnancy\n* malignancy\n* severe active infection\n* other rheumatic diseases or overlap\n* ALT(Alanine transaminase) or bilirubin \\> 3 folds\n* IVIG (Intravenous immunoglobulin) treatment during last 2 weeks\n* biologic agents during last 3 months'}, 'identificationModule': {'nctId': 'NCT02024334', 'acronym': 'JIA', 'briefTitle': 'Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': '900527'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'leflunomide', 'description': 'leflunomide tablet: for patients less than 20 kg: 10 mg every 2 day, for patients 20 - 40 kg: 10 mg daily, for patients more than 40 kg: 20 mg daily.', 'interventionNames': ['Drug: Leflunomide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo tablet for patients less than 20 kg: 10 mg every 2 day, for patients 20 - 40 kg: 10 mg daily, for patients more than 40 kg: 20 mg daily.'}], 'interventions': [{'name': 'Leflunomide', 'type': 'DRUG', 'otherNames': ['arava'], 'armGroupLabels': ['leflunomide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mashhad', 'state': 'Khorasan Razavi', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Zahra Rezaeiyazdi, MD', 'role': 'CONTACT', 'phone': '00989153115860'}, {'name': 'malihe bokaiyan, MD', 'role': 'SUB_INVESTIGATOR'}], 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'centralContacts': [{'name': 'Zahra Rezaieyazdi, MD', 'role': 'CONTACT', 'email': 'rezaieyazdiz@mums.ac.ir', 'phone': '009809153115860'}], 'overallOfficials': [{'name': 'Zahra Rezaieyazdi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rheumatic Diseases Research Center, Ghaem Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mashhad University of Medical Sciences', 'investigatorFullName': 'Zahra Rezaieyazdi', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}