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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Sarah McClure
+44 (0)115 8231604
moose@nottingham.ac.uk


Prof Abhishek Abhishek
+44 (0)115 8231392
abhishek.abhishek@nottingham.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - The MOOSE study: a trial to compare whether methotrexate injections are better at controlling rheumatoid arthritis, have less side effects and are more cost-effective than oral methotrexate tablets
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The MOOSE study: a trial to compare whether methotrexate injections are better at controlling rheumatoid arthritis, have less side effects and are more cost-effective than oral methotrexate tablets

Recruiting

Open to: All Genders

Age: Adult

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Medical Conditions

Rheumatoid arthritis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

29 Sep 2023 31 May 2025

MOOSE will be conducted in rheumatology centres in 30 hospitals. Whether participants 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 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. Also, 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.


Adults who have not previously been prescribed MTX for their RA treatment

You can take part if:



You may not be able to take part if:


1. RA previously treated with other disease-modifying anti-rheumatic drugs. Patients treated with hydroxychloroquine for palindromic RA or autoantibody-positive arthralgia are eligible.2. Psoriasis or other immune-mediated inflammatory conditions such as inflammatory bowel disease, ankylosing spondylitis, lupus, polymyalgia rheumatica or giant cell arteritis3. Dementia, severe psychological disturbance i.e. mental health illness that makes receiving study information and initial screening questions a stressful experience, 4. Unable to give informed consent or comply with study procedures5. Cancer treatment i.e. surgery, radiotherapy, immunotherapy or chemotherapy in the last 12 months; (current or past non-metastatic melanoma and skin cancer are eligible).6. Solid organ transplant on long-term daily prednisolone and/or other immunosuppressive treatments7. Stage 4/5 chronic kidney disease (CKD), chronic liver disease (e.g. autoimmune hepatitis, primary sclerosing cholangitis, hepatitis B or C, cirrhosis); low-dose methotrexate contraindicated8. Pregnant or breastfeeding9. Planning to become pregnant or breastfeed within the next 18 months10. For men, intending to start a family within the next 18 months11. Life expectancy less than 12 months


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Methotrexate is a long-standing treatment for rheumatoid arthritis and as such participants will have no greater risk than standard care. If participants experience side effects in either arm of the trial, these will be assessed as part of their usual clinic visits and the clinician will manage their treatment accordingly, as per standard care. Outside of clinical visits, a helpline phone number will be made available. Questionnaires will be given to patients at six timepoints, covering five different topics such as 'about your arthritis'. Some of the questions included may be sensitive and could lead to some distress to the patient, however, the likelihood of this occurring is low and comparable to sharing information at a standard care appointment. At baseline, 3 months, 6 months, and 12 months, questionnaires will be completed at clinic appointments, with the help of a research nurse if necessary, so patients will have the opportunity to discuss their current experience of their RA with their local care team. At 1 month and 2 months, questionnaires will be completed at home, and we will remind participants that they can contact their local care team using contact details provided on the PIS if they have any uncertainties.
When participants are taking part in the qualitative study, the interviewer will ask questions similar to the information they would share with a healthcare professional during an RA visit. The researcher would advise the patient to share any information that could impact their care with their local team after the interview.
Due to the risk of malformations associated with methotrexate, patients of childbearing potential will be asked to take a pregnancy test during the baseline visit, and in the absence of pregnancy, effective contraception must be used for the duration of the trial and 6 months thereafter. This will be discussed as part of the methotrexate educational training. The PIS clearly states that participants must not become pregnant whilst taking methotrexate or for 6 months after they stop taking methotrexate.

Dr Sarah McClure
+44 (0)115 8231604
moose@nottingham.ac.uk


Prof Abhishek Abhishek
+44 (0)115 8231392
abhishek.abhishek@nottingham.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Nottingham and funded by National Institute for Health and Care Research.




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Read full details for Trial ID: ISRCTN14403521

Or CPMS 56059

Last updated 17 March 2025

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