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

Phase 1CompletedNCT01871961

medac GmbH105 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Rheumatoid Arthritis (RA)

Interventions

Methotrexate (Metoject® prefilled pen)DRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Rheumatology Arthitis & Rheumatic Care center

South Miami, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 1 year

Data from ClinicalTrials.gov

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