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

Medac

Status and phase: Completed; Early Phase 1

Conditions: Juvenile Idiopathic Arthritis

Treatments: Device: methotrexate prefilled pen

Study type: Interventional

Funder types: Industry

Identifiers

NCT02052167

MC-MTX.16/HF Children

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 2 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Methotrexate

Experimental group

Treatment:

Device: methotrexate prefilled pen