Status:
COMPLETED
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient
Lead Sponsor:
medac GmbH
Collaborating Sponsors:
PPD Development, LP
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
16+ years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- Is a suitable candidate for treatment with Methotrexate for Rheumatoid Arthritis
- Male or female patient who is 16 years of age or older
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01871961
Start Date
October 1 2012
End Date
May 1 2013
Last Update
March 17 2015
Active Locations (1)
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1
Rheumatology Arthitis & Rheumatic Care center
South Miami, Florida, United States, 33143