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

Medac

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: methotrexate prefilled pen; Drug: methotrexate prefilled syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01793259

MC-MTX.11/RA

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

prefilled pen then prefilled syringe

Other group

Description:

weekly methotrexate injection with a prefilled pen during 3 weeks and subsequently with the prefilled syringe the last 3 weeks

Treatment:

Drug: methotrexate prefilled syringe

Drug: methotrexate prefilled pen

prefilled syringe then prefilled pen

Other group

Description:

weekly methotrexate injection with a prefilled syringe during 3 weeks and subsequently with the prefilled pen the last 3 weeks

Treatment:

Drug: methotrexate prefilled syringe

Drug: methotrexate prefilled pen