search
Back to results

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

Primary Purpose

Rheumatoid Arthritis (RA)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methotrexate (Metoject® prefilled pen)
Sponsored by
medac GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rheumatology Arthitis & Rheumatic Care center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methotrexate

Arm Description

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

Full Information

First Posted
May 14, 2013
Last Updated
March 13, 2015
Sponsor
medac GmbH
Collaborators
PPD
search

1. Study Identification

Unique Protocol Identification Number
NCT01871961
Brief Title
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
medac GmbH
Collaborators
PPD

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methotrexate (Metoject® prefilled pen)
Primary Outcome Measure Information:
Title
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).
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rheumatology Arthitis & Rheumatic Care center
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs