Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
methotrexate prefilled pen
Sponsored by
About this trial
This is an interventional device feasibility trial for Juvenile Idiopathic Arthritis
Eligibility 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
Sites / Locations
- Children's Mercy Hospital & Clinics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methotrexate
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of test case scenarios with observation and performance measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02052167
First Posted
January 27, 2014
Last Updated
March 26, 2018
Sponsor
medac GmbH
Collaborators
PPD
1. Study Identification
Unique Protocol Identification Number
NCT02052167
Brief Title
Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
medac GmbH
Collaborators
PPD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methotrexate
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
methotrexate prefilled pen
Primary Outcome Measure Information:
Title
Evaluation of test case scenarios with observation and performance measures
Description
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.
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Children's Mercy Hospital & Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis
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