Methotrexate in Patients with Early Rheumatoid Arthritis

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.

Conditions

• Rheumatoid Arthritis

Interventions

DRUG

Methotrexate

When accepted inclusion the patient will be included in SRQ, and thereafter randomised for Methotrexate per oral or subcutaneous administration

Sponsors & Collaborators

• Region Gävleborg

  collaborator OTHER

• Umeå University

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• County Council of Norrbotten, Sweden

  collaborator OTHER_GOV

• Vastra Gotaland Region

  collaborator OTHER_GOV

• Västernorrland County Council, Sweden

  collaborator OTHER_GOV

• Dalarna County Council, Sweden

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Region Jämtland Härjedalen

  collaborator OTHER

• Sormland County Council, Sweden

  collaborator OTHER

• Region Stockholm

  collaborator OTHER_GOV

• Region Västerbotten

  lead OTHER_GOV

Principal Investigators

• Anna Södergren, MD PhD · Region Västerbotten

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-28

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Sweden

Study Locations