Rheumatoid Arthritis (RA)
Conditions
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).
Interventions
Sponsors
PPD Development, LP
medac GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed