NCT05353829: MTXRA

Methotrexate in Patients with Early Rheumatoid Arthritis

Active, enrolled Phase 4 Last updated 14 January 2025

What this trial tests

Phase 4 trial testing Methotrexate in Rheumatoid Arthritis in 212 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 April 2022

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Region Västerbotten
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	212
Start date	28 April 2022
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	13 locations across Sweden

Drugs / interventions tested

• Methotrexate — full drug profile →

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Region Västerbotten — full company profile →

Who can join

Adults 18 to 95, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.