MethMax Trial
Research type
Research Study
Full title
An international, multicentre, interventional, randomised, assessor-blinded trial to MAXimise the METHotrexate therapy potential in patients with active rheumatoid arthritis (MethMax trial)
IRAS ID
1010008
Contact name
Daniel Aletaha
Contact email
Sponsor organisation
Medical University of Vienna
Eudract number
2023-507714-27
Clinicaltrials.gov Identifier
Research summary
Methotrexate (MTX) is recommended as the first line treatment of choice in patients newly diagnosed with rheumatoid arthritis (RA). Because of its well established efficacy, safety and tolerability it is considered as the anchor drug for RA. Regardless, achieving long-term remission with methotrexate monotherapy is only limited to a minority of RA patients. One contributing factor to this is the insufficient dose titration to the maximal recommended per oral (p.o.) dose in this indication (i.e. 25mg weekly), the late switch to subcutaneous (s.c.) route or even immediate switch to a biologic therapy when claimed ineffective via oral route.
Existing studies shows s.c. application of MTX being superior to oral administration because of the improved efficacy, bioavailability and reduced side effects (especially gastrointestinal adverse events being reduced by 30%). EULAR Guidelines suggests the maximized use of MTX dose and route to gain full effectiveness if no safety signals occur, particularly in patients who have already shown some initial response. Such early treatment response may be a useful biomarker to identify patients in whom a higher dose or a route switch may be warranted. Methotrexate undergoes complex metabolic pathways inside the body and releases active metabolites, methotrexate polyglutamates (MTX-PGs). The laboratory measurements of MTX-PGs can deepen the understanding of MTX-PG levels and their clinical role when changing the therapy route from p.o. to s.c.
In this trial, we aim to evaluate the clinical and biomarker response after an optimized MTX treatment regimen.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0058
Date of REC Opinion
14 Apr 2025
REC opinion
Further Information Favourable Opinion