MethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients with Active Rheumatoid Arthritis
NCT06649136 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 182
Last updated 2024-10-18
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.
Conditions
Interventions
- DRUG
-
Methotrexate
comparison between oral and subcutaneous methotrexate dosis of 25mg
Sponsors & Collaborators
-
Leiden University Medical Center
collaborator OTHER - collaborator OTHER
-
Queen Mary University of London
collaborator OTHER -
Diakonhjemmet Hospital AS
collaborator UNKNOWN -
Medical University of Vienna
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-12
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- Austria
Study Locations
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