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

Early Phase 1

Completed

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Device: methotrexate prefilled pen

• Registration Number: NCT02052167
• Lead Sponsor: medac GmbH

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Study Start: 2014-04
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methotrexate	methotrexate prefilled pen	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Mercy Hospital & Clinics; 🇺🇸 Kansas City, Missouri, United States