Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-25 @ 11:23 PM
Study NCT ID:
NCT02223195
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-12-08', 'releaseDate': '2023-03-03'}, {'resetDate': '2025-12-09', 'releaseDate': '2025-11-18'}], 'estimatedResultsFirstSubmitDate': '2023-03-03'}}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva sampels'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers in saliva, a comparison between healthy children and children with juvenile idiopathic arthritis.', 'timeFrame': 'one day', 'description': 'Saliva sampels will be colleceted and analysed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Juvenile Idiopathic Arthritis', 'Saliva'], 'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'Purpose and aims This as a pilot study that aims to investigate which inflammatory biomarkers can be found in saliva in children with Juvenile Idiopathic Arthritis (JIA).\n\nThe hypothesis is that children with JIA will show a different pattern of inflammatory biomarkers in saliva than healthy Children.\n\nThe null hypothesis is that there are no differences.', 'detailedDescription': 'This is a comparison between 100 children with JIA and 100 healthy children. Saliva will be collected and analyzed with respect to biomarkers.\n\nOne-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.\n\nInclusion criteria are:\n\n* age between 7 and 14 years\n* a diagnosis of JIA according to the International League of Associations for rheumatology\n\nExclusion criteria are:\n\n* current malignancies\n* TMJ surgery or trauma within two years\n* recent intra-articular glucocorticoid injection in TMJ (within 1 month)\n* other conditions or diseases than JIA that may cause orofacial pain. The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.\n\nThe control group of 100 age and sex matched healthy children will be included at Folktandvården Stockholms Län AB.\n\nInclusion criteria are:\n\n• age between 7 and 14 years\n\nExclusion criteria are:\n\n* current malignancies\n* TMJ surgery or trauma within two years\n* recent intra-articular glucocorticoid injection in TMJ (within 1 month)\n* A diagnosis of JIA\n* other conditions or diseases than JIA that may cause orofacial pain. The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1: 40 consecutive patients with active JIA, as diagnosed by the Department of Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.\n\nGroup 2: 40 healthy children, age-and sex-matched.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. A diagnosis of JIA according to the International League of Associations for rheumatology (ILAR) The parents of the patients and/or the patients will give their verbal and written informed consent to participate in the study according to the permission from the regional ethical committee 2011/2:1\n\nExclusion Criteria:\n\n1. current malignancies\n2. TMJ surgery or trauma within two years\n3. Recent intra-articular glucocorticoid injection in TMJ (within 1 month)\n4. Other conditions or diseases than JIA that may cause orofacial pain. Fore the controllgroup JIA are excluded'}, 'identificationModule': {'nctId': 'NCT02223195', 'briefTitle': 'Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Folktandvården Stockholms län AB'}, 'officialTitle': 'Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'MC 2'}}, 'contactsLocationsModule': {'locations': [{'zip': '17267', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Folktandvården Stockholmslän AB', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Britt Hedenberg Magnusson, PhD DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Folktandvården Stockholms län AB', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student, DDS', 'investigatorFullName': 'Malin Collin', 'investigatorAffiliation': 'Folktandvården Stockholms län AB'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-03-03', 'type': 'RELEASE'}, {'date': '2023-12-08', 'type': 'RESET'}, {'date': '2025-11-18', 'type': 'RELEASE'}, {'date': '2025-12-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Malin Collin, PhD student, DDS, Folktandvården Stockholms län AB'}}}}