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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- medac GmbH
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- number of patients preferring the MTX pre-filled pen to the pre-filled syringe
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
prefilled pen then prefilled syringe
weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks
Intervention: methotrexate prefilled pen (Drug)
prefilled pen then prefilled syringe
weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks
Intervention: methotrexate prefilled syringe (Drug)
prefilled syringe then prefilled pen
weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks
Intervention: methotrexate prefilled pen (Drug)
prefilled syringe then prefilled pen
weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks
Intervention: methotrexate prefilled syringe (Drug)
Outcomes
Primary Outcomes
number of patients preferring the MTX pre-filled pen to the pre-filled syringe
Time Frame: after 6 weeks of treatment
Secondary Outcomes
No secondary outcomes reported