Methotrexate in Patients With Early Rheumatoid Arthritis

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• The subject has given written consent to participate in the study

• Diagnosis of rheumatoid arthritis by rheumatologist fulfilling 2010

• Rheumatoid Arthritis Classification Criteria

• Indication of methotrexate

• 18-95 years of age

• Women of Childbearing Capacity (WOCBC) must:

1. Comply to use of highly effective contraception methods during the course of the trial.

2. Have a negative pregnancy test.

• Male patients included in the study that have fertile female partners must use adequate contraception within their relationship during the same period of time

Exclusion Criteria:

• Contraindications for methotrexate

• Previous treatment with any DMARD within the last five years

• Known or suspected allergies against methotrexate or any other substance in the given medication

• Anamnestic information on pregnancy, breastfeeding, or planned pregnancy

• Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation or inability to answer questionnaire in written Swedish

• Treatment or disease which, according to the investigator, can affect treatment or study results.

• Fear of needles leading to not being able to use subcutaneous injections

• For the study in gut microbiota: Use of antibiotics or probiotics within the last 3 months