NCT06649136 MethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients with Active Rheumatoid Arthritis

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 182 participants in total. It began in 2024-08-12 with a primary completion date of 2026-09-30.

Brief Summary

The MethMax trial is a prospective, international, multicentre, randomised, assessor-blinded, parallel-group, low intervention study. Patients with active rheumatoid arthritis treated with oral methotrexate up to 25mg weekly will be randomised in 50:50 fashion to receive 25mg oral vs subcutaneous methotrexate for the period of 24 weeks. In regular visits, patient reported outcomes, clinical disease activity, therapy adherence and diverse established and exploratory biomarkers will be assessed.

Eligibility Criteria

Inclusion Criteria: 1. Men and women, ≥ 18 years of age, capable of understanding and signing an informed consent (including sufficient literacy and proficiency in the local language) and following the study procedures 2. Patients with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria 3. Ongoing conventional therapy with oral methotrexate (between ≥10mg and 25mg weekly) for ≥3 months with stable dosing, and clinical and laboratory tolerance of this treatment for at least 12 weeks 4. CDAI \> 2.8 + at least 1 clinically swollen joint (on 28-Joint count) 5. Willingness to increase methotrexate dosing and change the route of administration according to study procedures Exclusion Criteria: 1. Inflammatory rheumatic diseases other than RA 2. Ongoing or previous therapy with any biological DiseaseModifying Anti-Rheumatic Drug (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) or conventional synthetic DMARDs (csDMARDs) other than methotrexate and hydroxychloroquine 3. Use of GC unless on stable oral dose ≤10mg for at least 4 weeks prior to study inclusion 4. Patients using NSAIDs, unless taken at a stable dose for ≥2 weeks prior to study inclusion 5. Intraarticular GC treatment in the last 8 weeks 6. Patients with significant and clinically relevant MTX-drug toxicity as judged by the investigator 7. Elevated liver enzymes (aspartate transaminase (ASAT) and/or alanine transaminase (ALAT)), and/or alkaline phosphatase (AP), and/or gamma-glutamyl transferase (GGT) above 2x the upper limit normal (ULN) 8. Reduced kidney function (glomerular filtration rate (GFR)\<60) 9. Haematologic abnormalities (grade 2 or 3: anaemia, leukopenia, thrombocytopenia) 10. Stomatitis under the treatment with MTX 11. Known history of recurrent/serious infections in the previous two months (such as, but not limited to, hepatitis, pneumonia, or pyelonephritis) 12. A positive HBsAg and/or HCV test at screening visit 13. Ongoing or recurring opportunistic infections (e.g., herpes zoster, cytomegalovirus, pneumocystis, aspergillosis, histoplasmosis, or mycobacteria) as judged by the investigator 14. Women of childbearing potential without the use of adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) and willing to continue this precaution for the duration of the study until 6 months after receiving the last medication 15. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, as judged by the investigator 16. Being unable or unwilling to undergo multiple venepunctures because of poor tolerability or lack of sufficient venous access 17. Being unwilling or unable to perform s.c injections 18. Presence of a transplanted solid organ (with the exception of a corneal transplant \> 3 months prior to screening) 19. Women who are pregnant, nursing; or planning pregnancy during the study and 6 months after the individual study completion 20. History of alcohol or substance abuse within the preceding 6 months 21. Any medical or psychological condition that, judged by the investigator, would interfere with safe completion of the trial 22. Immunisation with a live/attenuated vaccine within 12 weeks prior to baseline or potential need to receive a live vaccine during the course of the study 23. Active participation in any other interventional study

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