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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by medac GmbH
Sponsor:
Information provided by (Responsible Party):
medac GmbH
ClinicalTrials.gov Identifier:
NCT02052167
First received: January 27, 2014
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention
Juvenile Idiopathic Arthritis
Drug: methotrexate prefilled pen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by medac GmbH:

Primary Outcome Measures:
  • Evaluation of test case scenarios with observation and performance measures [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methotrexate Drug: methotrexate prefilled pen

  Eligibility

Ages Eligible for Study:   2 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052167

Locations
United States, Missouri
Children's Mercy Hospital & Clinics Not yet recruiting
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
medac GmbH
  More Information

No publications provided

Responsible Party: medac GmbH
ClinicalTrials.gov Identifier: NCT02052167     History of Changes
Other Study ID Numbers: MC-MTX.16/HF Children
Study First Received: January 27, 2014
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014