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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01793259

Enrollment

120

Registered

2013-02-15

Start date

2012-07-31

Completion date

2013-06-30

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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

Interventions

DRUGmethotrexate prefilled pen

DRUGmethotrexate prefilled syringe

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026