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CompletedNCT02052167Updated Mar 29, 2018

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

An Early Phase 1 interventional study of methotrexate prefilled pen in Juvenile Idiopathic Arthritis, sponsored by medac GmbH. Completed at 1 site in United States. Open to participants aged 2 Years to 20 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by medac GmbH · Early Phase 1, Interventional, and Device feasibility

Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
2 Years to 20 Years
Sex
All
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Study 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).

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Conditions studied

  • Juvenile Idiopathic Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

medac GmbH is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 20 Years
Sexes eligible
All
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
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Study design

Phase
Early Phase 1
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Methotrexate

    Device: methotrexate prefilled pen

Interventions

  • Devicemethotrexate prefilled pen
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 days

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Study locations

1 site
  • Children's Mercy Hospital & Clinics
    Kansas City, Missouri 64108, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02052167
Lead sponsor
medac GmbH
Collaborators
PPD DEVELOPMENT, LP
Responsible party
Sponsor
First posted
Jan 31, 2014
Start date
Apr 2014
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Mar 29, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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