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

Phase 1

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Methotrexate	Methotrexate (Metoject® prefilled pen)	-

Primary Outcome Measures

Name	Time	Method
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).	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

Secondary Outcome Measures

Name	Time	Method

Locations (1): Rheumatology Arthitis & Rheumatic Care center
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South Miami, Florida, United States

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