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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methotrexate

Group Type EXPERIMENTAL

Methotrexate (Metoject® prefilled pen)

Intervention Type DRUG

Interventions

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Methotrexate (Metoject® prefilled pen)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No