Juvenile Idiopathic Arthritis
Conditions
Brief 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).
Interventions
Sponsors
medac GmbH
PPD Development, LP
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 20 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of test case scenarios with observation and performance measures | 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. |
Countries
United States
Outcome results
None listed