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

medac GmbH120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Rheumatoid Arthritis

Interventions

methotrexate prefilled penDRUG

methotrexate prefilled syringeDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kerckhoff Clinic

Bad Nauheim, Germany

Outcomes

Primary Outcomes

number of patients preferring the MTX pre-filled pen to the pre-filled syringe

Time frame: after 6 weeks of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.