Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 2 - 20 |
| Updated: | 4/17/2018 |
| Start Date: | April 2014 |
| End Date: | August 2014 |
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).
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
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