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MethMax trial
EU CTIS ID: 2023-507714-27-00
What this study is testing
To assess the proportion of patients in the Clinical Disease Activity Index (CDAI) remission (≤2.8) at week 24.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Patients with rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria
- 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
- CDAI > 2.8 + at least 1 clinically swollen joint (on 28-Joint count)
- Willingness to increase methotrexate dosing and change the route of administration according to study procedures
You likely can't join if
- Inflammatory rheumatic diseases other than RA
- Stomatitis under the treatment with MTX
- Known history of recurrent/serious infections in the previous two months (such as, but not limited to, Hepatitis, Pneumonia, or Pyelonephritis)
- A positive HBsAg and/or HCV test at screening visit
- Ongoing or recurring opportunistic infections (e.g., Herpes Zoster, Cytomegalovirus, Pneumocystis, Aspergillosis, Histoplasmosis, or Mycobacteria other than TB) as judged by the investigator
- Women of childbearing potential without 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 willingness to continue this precaution for the duration of the study until 6 months after receiving the last medication
See the full eligibility criteria
Who can join
- 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
- Patients with rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria
- 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
- CDAI > 2.8 + at least 1 clinically swollen joint (on 28-Joint count)
- Willingness to increase methotrexate dosing and change the route of administration according to study procedures
What rules you out
- Inflammatory rheumatic diseases other than RA
- Stomatitis under the treatment with MTX
- Known history of recurrent/serious infections in the previous two months (such as, but not limited to, Hepatitis, Pneumonia, or Pyelonephritis)
- A positive HBsAg and/or HCV test at screening visit
- Ongoing or recurring opportunistic infections (e.g., Herpes Zoster, Cytomegalovirus, Pneumocystis, Aspergillosis, Histoplasmosis, or Mycobacteria other than TB) as judged by the investigator
- Women of childbearing potential without 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 willingness to continue this precaution for the duration of the study until 6 months after receiving the last medication
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, as judged by the investigator
- Being unable or unwilling to undergo multiple venepunctures because of poor tolerability or lack of sufficient venous access
- Being unwilling or unable to perform s.c injections
- Presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening)
- Women who are pregnant, nursing; or planning pregnancy during the study and 6 months after the individual study completion
- Ongoing or previous therapy with any targeted synthetic DMARDs (tsDMARD) or biological Disease-Modifying Anti-Rheumatic Drug (bDMARD) with the exception of any TNFα inhibitor in a stable dose and interval for at least 4 months; we allow ongoing or previous therapy with a conventional synthetic DMARD (csDMARD) with a stable dose in the past 4 months.
- History of alcohol or substance abuse within the preceding 6 months
- Any medical or psychological condition that, judged by the investigator, would interfere with safe completion of the trial
- Immunization 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
- Active participation in any other interventional study
- Use of GC unless on stable oral dose ≤10mg for at least 4 weeks prior to study inclusion
- Patients using NSAIDs, unless taken at a stable dose for ≥2 weeks prior to study inclusion
- Intraarticular GC treatment in the last 8 weeks
- Patients with significant and clinically relevant MTX-drug toxicity as judged by the investigator
- 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)
- Reduced kidney function (glomerular filtration rate (GFR)<60mL/min/1.73m2)
- Hematologic abnormalities (Grade 2 or 3: Anaemia, Leukopenia, Thrombocytopenia)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.