Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis

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

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).

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