Actively Recruiting
MethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients with Active Rheumatoid Arthritis
Led by Medical University of Vienna · Updated on 2024-10-18
182
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
Sponsors
M
Medical University of Vienna
Lead Sponsor
L
Leiden University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients with Active Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older who can understand and sign informed consent and follow study procedures
- Diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR criteria
- Taking stable oral methotrexate between 10 mg and 25 mg weekly for at least 3 months with good clinical and laboratory tolerance for 12 weeks
- Clinical Disease Activity Index (CDAI) above 2.8 and at least one clinically swollen joint
- Willing to increase methotrexate dose and change administration route as per study plan
You will not qualify if you...
- Having inflammatory rheumatic diseases other than rheumatoid arthritis
- Current or past treatment with biologic, targeted synthetic, or other conventional synthetic DMARDs besides methotrexate or hydroxychloroquine
- Use of glucocorticoids unless stable oral dose of 10 mg or less for at least 4 weeks before study
- Using NSAIDs unless at stable dose for 2 weeks prior to study
- Intraarticular glucocorticoid treatment within the last 8 weeks
- Significant methotrexate toxicity or elevated liver enzymes above twice the normal limit
- Reduced kidney function with glomerular filtration rate below 60
- Moderate to severe blood abnormalities such as anemia, leukopenia, or thrombocytopenia
- Stomatitis during methotrexate treatment
- Recent serious or recurrent infections in the last 2 months
- Positive hepatitis B or C test at screening
- Ongoing opportunistic infections
- Women of childbearing potential not using adequate birth control and unwilling to maintain it during study and 6 months after
- Severe or uncontrolled diseases affecting organs or systems as judged by investigator
- Inability or unwillingness to undergo multiple blood draws or perform subcutaneous injections
- Presence of a transplanted solid organ except corneal transplant older than 3 months
- Pregnant, nursing, or planning pregnancy during study and 6 months after
- Alcohol or substance abuse in the last 6 months
- Any medical or psychological condition interfering with safe trial completion
- Recent or planned live vaccination within 12 weeks before or during study
- Participation in another interventional study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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