NCT02052167

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

January 27, 2014

Last Update Submit

March 26, 2018

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

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.

    8 days

Study Arms (1)

Methotrexate

EXPERIMENTAL
Device: methotrexate prefilled pen

Interventions

methotrexate prefilled penDEVICE
Methotrexate

Eligibility Criteria

Age2 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital & Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 31, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

US(1)