NCT01793259

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: medac GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	methotrexate prefilled pen
DRUG	methotrexate prefilled syringe

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2013-02-15
• Last updated: 2013-07-15

Locations

1 site across 1 country: Germany