Trial | NCT01793259  Report issue

Title

Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    naltrexone ...

  • Study Participants

    120
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
Study Started
Jul 31
2012
Primary Completion
Apr 30
2013
Study Completion
Jun 30
2013
Last Update
Jul 15
2013
Estimate

Drug methotrexate prefilled pen

Drug methotrexate prefilled syringe

prefilled pen then prefilled syringe Other

weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks

prefilled syringe then prefilled pen Other

weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks

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.
No Results Posted