Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-11 @ 9:27 AM
Study NCT ID:
NCT04042792
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2019-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010599', 'term': 'Pharmacokinetics'}, {'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D002620', 'term': 'Pharmacological and Toxicological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADA concentration (in mg/L)', 'timeFrame': 'at study inclusion', 'description': 'ADA concentration (in mg/L)'}, {'measure': 'ADA concentration (in mg/L)', 'timeFrame': 'during regular clinical follow up 3-6 months after inclusion', 'description': 'ADA concentration (in mg/L)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'pharmacodynamics', 'Adalimumab', 'methotrexate', 'drug-drug interaction', 'trough ADA concentration', 'peak ADA concentration', 'Pediatric inflammatory rheumatic diseases'], 'conditions': ['Rheumatic Diseases']}, 'referencesModule': {'references': [{'pmid': '38167019', 'type': 'DERIVED', 'citation': 'Welzel T, Golhen K, Atkinson A, Gotta V, Ternant D, Kuemmerle-Deschner JB, Michler C, Koch G, van den Anker JN, Pfister M, Woerner A. Prospective study to characterize adalimumab exposure in pediatric patients with rheumatic diseases. Pediatr Rheumatol Online J. 2024 Jan 2;22(1):5. doi: 10.1186/s12969-023-00930-8.'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to assess peak and trough ADA concentrations in ADA naïve patients after first ADA administration with and without MTX (pre-phase).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "PiRD patients treated with ADA for medical reasons at the University Children's Hospital Basel/ Switzerland and at the University Children's Hospital of Tuebingen/ Germany", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of a juvenile idiopathic Arthritis (JIA), uveitis or chronic recurrent multifocal osteomyelitis (CRMO)\n* Medical indication for initiation of ADA treatment or established ADA therapy for ≥ 12 weeks\n* Exclusion of chronic infections\n* No parallel treatment with other biologic medications\n* Available patient history since ADA start\n* No pregnancy\n* Ability to comply with the entire study protocol\n* Willingness to participate with signed informed consent\n\nExclusion Criteria:\n\n* Other rheumatic inflammatory diseases\n* Age \\< 2 years or \\>18 years\n* PiRD patients and parents with cognitive impairments preventing to understand study requirements\n* Additional severe chronic disease (kidney failure, liver insufficiency), malignancies or prior chemotherapy'}, 'identificationModule': {'nctId': 'NCT04042792', 'acronym': 'ADA in PiRD', 'briefTitle': 'Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)', 'orgStudyIdInfo': {'id': '2019-00916; ks18Pfister2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ADA for ≥12 weeks and concomitant MTX therapy', 'description': 'PiRD patients with ADA for ≥12 weeks and concomitant MTX therapy (oral or subcutaneous)', 'interventionNames': ['Other: pharmacokinetics (PK) measurement']}, {'label': 'ADA for ≥ 12 weeks without MTX', 'description': 'PiRD patients with ADA for ≥ 12 weeks without MTX ≥ 12 weeks (or never exposed to MTX)', 'interventionNames': ['Other: pharmacokinetics (PK) measurement']}], 'interventions': [{'name': 'pharmacokinetics (PK) measurement', 'type': 'OTHER', 'description': 'two ADA-PK samples will be collected during routine rheumatology visits in case of medical indicated blood draw (1 trough PK sample and 1 random PK sample per subject)', 'armGroupLabels': ['ADA for ≥ 12 weeks without MTX', 'ADA for ≥12 weeks and concomitant MTX therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': "University Children's Hospital Tubingen", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': "University of Basel Children's Hospital", 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Marc Pfister, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital Basel (UKBB), University of Basel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}