NCT05353829Active, not recruitingPhase 4
Methotrexate in Patients with Early Rheumatoid Arthritis
Efficacy, Tolerability and Preferences of Per Oral or Subcutaneous Methotrexate in Patients with Early Rheumatoid Arthritis - a Randomised Register Based Multicentre Study
Source: ClinicalTrials.gov · Last updated 14 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- First submitted
- 11 May 2021
- Start date
- 28 Apr 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Region Västerbotten
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05353829
- EU CT number
- 2024-512453-25-00
- EudraCT number
- 2020-000462-41
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 212
- From 28 Apr 2022 to the primary completion date, 31 Dec 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with any DMARD within the last five years
Other illness
- Known or suspected allergies against methotrexate or any other substance in the given medication
- Treatment or disease which, according to the investigator, can affect treatment or study results.
Other
- Contraindications for methotrexate
- 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
- 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
Who the study is looking for
- 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:
- Comply to use of highly effective contraception methods during the course of the trial.
- 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
Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Malarsjukhuset Eskilstuna Coordinator of this site? Confirm its status | Eskilstuna | Sweden | Active, not recruiting |
| Region Dalarna Coordinator of this site? Confirm its status | Falun | Sweden | Active, not recruiting |
| Region Gaevleborg Coordinator of this site? Confirm its status | Gavle | Sweden | Active, not recruiting |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Active, not recruiting |
| Skaraborg Hospital-Vastra Gotalandsregionen Coordinator of this site? Confirm its status | Skovde | Sweden | Active, not recruiting |
| Region Stockholm – SLSO Coordinator of this site? Confirm its status | Stockholm | Sweden | Active, not recruiting |
| Region Vaesternorrland Coordinator of this site? Confirm its status | Sundsvall | Sweden | Active, not recruiting |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Active, not recruiting |
| Region Vaestmanland Coordinator of this site? Confirm its status | Vasteras | Sweden | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.