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

Last updated: July 12, 2013
Sponsor: medac GmbH
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT01793259
MC-MTX.11/RA
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion

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 ofcontraception or men who have a partner with child-bearing potential and do not use acontraception during the study and at least 6 months thereafter.

Study Design

Total Participants: 120
Study Start date:
July 01, 2012
Estimated Completion Date:
June 30, 2013

Connect with a study center

  • Kerckhoff Clinic

    Bad Nauheim, 61231
    Germany

    Site Not Available

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