Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02052167
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2014-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients 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': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-26', 'studyFirstSubmitDate': '2014-01-27', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of test case scenarios with observation and performance measures', 'timeFrame': '8 days', 'description': 'Test case scenarios were designed to determine if the potential risks associated with the use of the prefilled pen were mitigated by information contained in the patient leaflet and the training provided to each patient or caregiver. The test case scenarios with observation and performance measures will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the Methotrexate Prefilled Pen (including a label comprehension assessment and a device robustness evaluation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* patient of either gender aged ≥2 to \\<21 years of age\n* is a suitable candidate for treatment with injectable methotrexate for JIA per the patient's primary rheumatologist, with the previous or current diagnosis of active polyarticular course JIA\n\nMain Exclusion Criteria:\n\n* Is a female patient who is pregnant, trying to become pregnant, or breastfeeding, or of childbearing potential, sexually active but not practicing a highly reliable method of birth control during the study and at least 6 months thereafter\n* Has contraindications for methotrexate\n* Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than JIA\n* Is unable, or does not have a caregiver able to comprehend written labeling and training materials"}, 'identificationModule': {'nctId': 'NCT02052167', 'briefTitle': 'Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'medac GmbH'}, 'officialTitle': 'Human Factors Study for the Evaluation of the Methotrexate Prefilled Pen (50 mg/mL) for Subcutaneous Injection in Pediatric and Adolescent Patients With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'MC-MTX.16/HF Children'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methotrexate', 'interventionNames': ['Device: methotrexate prefilled pen']}], 'interventions': [{'name': 'methotrexate prefilled pen', 'type': 'DEVICE', 'armGroupLabels': ['Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital & Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'medac GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PPD Development, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}