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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH
• Collaborator: PPD
• Treatments: Methotrexate

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