What is the study about?

Rheumatoid arthritis (RA) is treated with medicines such as methotrexate that control inflammation and prevent joint damage.

In the UK, methotrexate is usually prescribed as weekly tablets for treating RA. Some people may have side effects such as sickness and they may then be prescribed weekly injections of methotrexate. These injections are self-administered to just below the skin in the thigh or the tummy.

Methotrexate injections may be more effective in controlling arthritis and cause fewer side-effects than tablets.

However, it costs 20 times more than methotrexate tablets. The MOOSE study aims to determine whether methotrexate injection is more effective than tablet and should be used as the first-choice treatment for patients with RA.

Who can take part in the study?

Adults with active rheumatoid arthritis who are being offered methotrexate for the first time.

What is being tested in the study?

Subcutaneous methotrexate injections, with 4 weekly dose escalation.

What is this being compared to?

Oral methotrexate tablets, with 4 weekly dose escalation.

What are we trying to find out?

The MOOSE study will find out whether methotrexate injections are more effective than tablets in controlling RA and for improving wellbeing. It will also find out whether they are acceptable to people with arthritis and value for money for the NHS.

How many patients do we need?

386 participants will allow detection of an absolute difference of 17.5% in the proportion of participants showing remission 24 weeks after randomisation, with 90% power, and a 5% significance level (2-sided).

Funder

National Institute for Health and Care Research - Health Technology Assessment (NIHR - HTA)