Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis
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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).
Evaluation of test case scenarios with observation and performance measures [ Time Frame: 8 days ]
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.
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Ages Eligible for Study:
2 Years to 20 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
patient of either gender aged ≥2 to <21 years of age
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
Main Exclusion Criteria:
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
Has contraindications for methotrexate
Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than JIA
Is unable, or does not have a caregiver able to comprehend written labeling and training materials