Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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 questionnaire

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.