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

Launched by MEDICAL UNIVERSITY OF VIENNA · Oct 17, 2024

Keywords

ClinConnect Summary

The MethMax Trial is studying how to improve treatment for people with active rheumatoid arthritis (RA) by comparing two ways of taking methotrexate, a common medication. Participants in the trial will be randomly assigned to either take methotrexate as a pill or receive it as an injection under the skin for 24 weeks. The goal is to see which method works better for managing their symptoms and improving their quality of life.

To join the trial, participants must be at least 18 years old, have a confirmed diagnosis of RA, and have been taking a stable dose of oral methotrexate for at least three months. They should also have some swelling in their joints and be willing to change how they take their medication. Throughout the study, participants will have regular check-ups where they will discuss their condition and how well they are sticking to the treatment plan. It's important to note that certain health conditions and treatments may exclude someone from participating, so those interested should talk to their doctor for more details.

Gender

ALL

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