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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: methotrexate prefilled pen; Drug: methotrexate prefilled syringe

• Registration Number: NCT01793259
• Lead Sponsor: medac GmbH

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
prefilled pen then prefilled syringe	methotrexate prefilled pen	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	methotrexate prefilled pen	weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks
prefilled pen then prefilled syringe	methotrexate prefilled syringe	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	methotrexate prefilled syringe	weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks

Primary Outcome Measures

Name	Time	Method
number of patients preferring the MTX pre-filled pen to the pre-filled syringe	after 6 weeks of treatment

Trial Locations

Locations (1)

Kerckhoff Clinic; 🇩🇪 Bad Nauheim, Germany