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

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis (RA)

In brief

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).

Key facts

Study ID

NCT01871961

Run by

medac GmbH

People needed

105

Starts

2012-10-01

Expected to finish

2013-05-01

Last updated by the study team

2015-03-17

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
• Male or female patient who is 16 years of age or older

You may not qualify if…

• 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

Where it is running

• Rheumatology Arthitis & Rheumatic Care center — South Miami, Florida, United States

Full record on ClinicalTrials.gov

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