Methotrexate in Patients With Early Rheumatoid Arthritis
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Region Västerbotten
Collaborators:
County Council of Norrbotten, Sweden Dalarna County Council, Sweden Danderyd Hospital Jämtland County Council, Sweden Karolinska University Hospital Region Gävleborg Region Stockholm Sormland County Council, Sweden Umeå University Uppsala University Västernorrland County Council, Sweden Vastra Gotaland Region