Methotrexate Adherence Project
Research type
Research Study
Full title
Adherence to Methotrexate in Rheumatoid Arthritis: Effect of an Information Booklet on Methotrexate Levels
IRAS ID
189766
Contact name
Sandra Robinson
Contact email
Sponsor organisation
Northumbria Healthcare NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
The aim of this study is to explore the effect of a Rheumatoid Arthritis (RA) Information booklet on the disease management of patients with RA who are taking Methotrexate. Methotrexate is the default disease modifying drug (DMARD) for treatment of RA. It is a drug; which has a delayed onset of action and where the majority of patients, even those continuing on treatment, have side effects that they tolerate in order to stay on the drug. Poor disease management in the form of not taking Methotrexate as prescribed can give the impression that the therapy has failed which could have an economic impact on the NHS. Chugai/Roche produced a booklet for people who have Rheumatoid Arthritis. This has been designed to prompt the patients to think about and assess how their treatment suits them.\nWe also wish to determine if the measurement of red blood cell glutamate levels reflect drug compliance.\nParticipants with Rheumatoid Arthritis and on a stable dose on Methotrexate for at least 3 months would be eligible for inclusion in this study.\nThe study will last for 18 months; each participant will be given a knowledge questionnaire and a Methotrexate adherence questionnaire to complete on enrollment in the study. They will then have a blood sample taken during their routine Methotrexate blood monitoring. Participants will be randomised 1:1 to receive the booklet. All participants will repeat the questionnaires at 3 – 6 months when they return for their regular blood monitoring visit and blood samples will be drawn.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0191
Date of REC Opinion
10 Sep 2018
REC opinion
Further Information Favourable Opinion