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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793259
• Other study ID #: MC-MTX.11/RA
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2013
• Last updated: July 12, 2013
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: medac GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• methotrexate prefilled pen

• methotrexate prefilled syringe

Locations

Country	Name	City	State
Germany	Kerckhoff Clinic	Bad Nauheim

Sponsors (1)

Lead Sponsor	Collaborator
medac GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients preferring the MTX pre-filled pen to the pre-filled syringe		after 6 weeks of treatment	No