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

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 30
• Participant gender: Both

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH
• Collaborator: PPD
• Treatments: Methotrexate
• Last Updated: 2015-03-13

Criteria

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