Efficacy, tolerability and preferences of per oral or subcutaneous methotrexate in patients with early rheumatoid arthritis – a randomised register based multicentre study

Rheumatoid arthritis (RA) is an inflammatory rheumatic disease that mainly affects the joints, but also affect other organs. Delayed or insufficient treatment can lead to joint destruction and disability.

Drug treatment for RA is in the form of disease modifying antirheumatic drugs, where methotrexate is the first choice where there are no contraindications. However, methotrexate has in many cases side effects.

Methotrexate is available in two administation routs; per oral or as subcutaneous injection, peroral being the most common.

The latter preparation has in studies shown better bioavailability and thus has a potential better treatment effect, and can also be assumed to have fewer gastrointestinal side effects.

The main purpose of this study is to compare the efficacy and tolerability of per oral and subcutaneous methotrexate during the first 24 months after diagnosis of RA.

In addition, the gut microbita and patients´ preferences regarding administration route will be studied and a health economic analysis will be performed.

The study will be performed in the form of a register-randomized multicenter study in which patients with newly diagnosed RA are offered inclusion.

This application concerns funds to enable the development of a register-randomized method within the Swedish Rheumatology´s quality register (SRQ), develop eCRF for monitoring within the same platform and enable start-up meetings with involved investigators in different centras in Sweden.