Methotrexate Oral Or SubcutanEous for RA
Research type
Research Study
Full title
Multi-centre randomised open-label assessor-blinded two arm parallel group trial of subcutaneous versus oral methotrexate for rheumatoid arthritis (RA) with internal feasibility assessment, economic evaluation and qualitative study.
IRAS ID
1006576
Contact name
Abhishek Abhishek
Contact email
ISRCTN Number
ISRCTN14403521
Research summary
Rheumatoid arthritis (RA) is treated with medicines such as methotrexate (MTX) that control
inflammation and prevent joint damage. MTX is usually prescribed as weekly
tablets for treating RA. If side effects are experienced, participants may be
prescribed weekly injections of MTX instead of tablets.
A small amount of evidence suggests that MTX injections are more effective in
controlling arthritis and cause fewer side-effects than tablets. However, injections cost 20 times more than MTX tablets.
This study will find out whether MTX injections are more effective than tablets in
controlling RA, improving wellbeing, and whether MTX injections are acceptable to people
with arthritis and value for money for the NHS.
MOOSE is funded by NIHR HTA, and will be conducted in rheumatology centres in 30 hospitals. 386 adults will be recruited, who have not previously been prescribed MTX for their RA treatment. Whether they are prescribed MTX as a tablet or as an injection will be decided randomly.
A research nurse will see participants at the start of the study. RA will be assessed by examining the joints and taking a blood sample to measure the level of inflammation. MTX treatment will start at a low dose and may be increased at the clinic visits over the next 2-3 months, depending on how the participant’s RA is improving and if they are having side effects. At 12, 24 and 52 weeks, one of the clinical care team will carry out the RA assessment. They will not know which treatment the participant has been taking, so that their assessment cannot be influenced by this.
Participants will complete questionnaires before their clinical assessment, with the help of the research nurse. They will ask about their arthritis, daily activities and work, well-being, fatigue, and mental health.
20 participants will be invited to take part in treatment acceptability interviews, at 1-2 months and 6-8 months.
Participation is for 12 months or until the final clinical assessment.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0125
Date of REC Opinion
2 Aug 2023
REC opinion
Further Information Favourable Opinion