Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient

March 13, 2015 updated by: medac GmbH

Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery

To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • Rheumatology Arthitis & Rheumatic Care center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
  • Male or female patient who is 16 years of age or older

Exclusion Criteria:

  • Is a female patient who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
  • Has any history of hypersensitivity to the investigational medicinal product
  • Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than Rheumatoid Arthritis (RA)
  • Is unable to comprehend written labeling and training materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methotrexate
Drug: Methotrexate (Metoject® prefilled pen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
Time Frame: 1 year
Questionnaires to assess the comprehension of the label (instruction for use of the prefilled pen) and device robustness evaluation after usage of the prefilled pen
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

medac GmbH

Collaborators

PPD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-MTX.15/HF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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