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Methotrexate in Patients with Early Rheumatoid Arthritis

Study acronym: MTXRA
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 13 of 13 sites
    v5
  2. Minor Collaborators: 12 to 11v4
  3. Notable Enrollment target: 80 to 212
    • Study sites: 11 to 13
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 11 of 11 sites
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)
Rheumatoid Arthritis
Related terms Arthritis, Rheumatoid, Patient Preference
Enrollment 212 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov