Methotrexate in Patients with Early Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease primarily affecting the small joints of hands and feet, but may also present with systemic, extraarticular features. The Swedish Rheumatology Quality Register (SRQ) is a nationwide quality register with the aim of continuously improving the treatment and follow-up of patients with rheumatic disease. Using this type of quality registers, it is possible to perform a Registrybased Randomised Clinical Trial (R-RCT), that is a randomised clinical trial this is carried out by screening, recruitment and registration of study data is performed based on information given by a quality register. All patients with newly diagnosed RA are included in SRQ. Treatment options for RA include different types of immunosuppression and corticosteroids as bridging therapy. Methotrexate, a synthetic conventional disease modifying antirheumatic drug (csDMARD), which can be given either orally or subcutaneously, is considered a first-line treatment. Studies have shown the beneficial efficacy and improved quality of life for patients with RA treated with methotrexate, however this is not studied in a setting of unselected patients with newly diagnosed RA in northern Sweden. Moreover, it is not known to what extent patients prefer oral or subcutaneous administration route, or if there are any health economic benefits from either of the two administration routes. Further, changes in gut microbiota is not studied in this setting.

NCT Number	NCT05353829
Lead Sponsor	Region Västerbotten Collaborators: Region Gävleborg, Umeå University, Uppsala University, County Council of Norrbotten, Sweden, Vastra Gotaland Region, Västernorrland County Council, Sweden, Dalarna County Council, Sweden, Karolinska University Hospital, Region Jämtland Härjedalen, Sormland County Council, Sweden, Region Stockholm
Conditions	Rheumatoid Arthritis
Enrollment	212 participants
Start Date	2022-04-28
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-14