Status:
COMPLETED
Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
Lead Sponsor:
medac GmbH
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a question...
Eligibility Criteria
Inclusion
- Written informed consent
- Age between 18 and 75 years
- Rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria 1987 or ACR/European Liga Against Rheumatology (EULAR)2010
- Disease activity score (DAS) 28 \> 2.6
- Main
Exclusion
- Prior or other current subcutaneous treatment with self-injection
- Prior or concomitant treatment with biologics
- Contraindications to MTX treatment
- History or diagnosis of a dermatological disease at the injection site
- Women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01793259
Start Date
July 1 2012
End Date
June 1 2013
Last Update
July 15 2013
Active Locations (1)
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1
Kerckhoff Clinic
Bad Nauheim, Germany, 61231