Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT00801593
Status:
UNKNOWN
Last Update Posted:
2008-12-03
First Post:
2008-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-12-02', 'studyFirstSubmitDate': '2008-12-02', 'studyFirstSubmitQcDate': '2008-12-02', 'lastUpdatePostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TMJ arthritis on MRI', 'timeFrame': 'every three to six months from recruitment to end of study'}], 'secondaryOutcomes': [{'measure': 'TMJ arthritis on ultrasound', 'timeFrame': 'every three to six months from recruitment to end of study'}, {'measure': 'Action of current medication on TMJ arthritis.', 'timeFrame': 'every three to six months from recruitment to end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['JIA'], 'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'Children with juvenile idiopathic arthritis (JIA) suffer in up to 87% of the cases of arthritis of the temporomandibular joints (TMJs). Magnetic resonance imaging (MRI) is the only modality for the early diagnosis of TMJ involvement.\n\nAim of the study is to compare symptoms and clinical findings with MRI and ultrasonography results and to describe the action of the current medication on the arthritis of the TMJs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with JIA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with defined JIA.\n\nExclusion Criteria:\n\n* Children without defined diagnosis of JIA.'}, 'identificationModule': {'nctId': 'NCT00801593', 'briefTitle': 'Magnetic Resonance Imaging Follow-up on Temporomandibular Arthritis in Children With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Arthritis of the Temporomandibular Joints in Children With Juvenile Idiopathic Arthritis- Pilot Study on Diagnostic Value of Ultrasonography and Magnetic Resonance Imaging and Influence of Drug Treatment', 'orgStudyIdInfo': {'id': 'TMJ PROSPECT2008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with JIA', 'interventionNames': ['Procedure: Steroid injection into the TMJs.']}], 'interventions': [{'name': 'Steroid injection into the TMJs.', 'type': 'PROCEDURE', 'description': 'In case of otherwise noncontrollable TMJ involvement steroids are injected into arthritic TMJs under MRI guidance.', 'armGroupLabels': ['Children with JIA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nikolay Tzaribachev, MD', 'role': 'CONTACT', 'email': 'nikolay.tzaribachev@med.uni-tuebingen.de', 'phone': '+49707129', 'phoneExt': '84711'}, {'name': 'Nikolay Tzaribachev, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "University Children's Hospital", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'centralContacts': [{'name': 'Nikolay Tzaribachev, MD', 'role': 'CONTACT', 'email': 'nikolay.tzaribachev@med.uni-tuebingen.de', 'phone': '+49707129', 'phoneExt': '84711'}], 'overallOfficials': [{'name': 'Nikolay Tzaribachev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tuebingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nikolay Tzaribachev, Dr.', 'oldOrganization': "University Children's Hospital, Tuebingen"}}}}