drugset / Trial / NCT04483466
Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH)
RandomizedParallel-groupDouble-blindTreatment
Summary
MARCH is the first randomized, double-blind, placebo-controlled evaluation of the efficacy and pathologic mechanism determined by synovial biopsy of 6 months of methotrexate (n=100) versus placebo (n=50) therapy for chronic chikungunya (CHIKV) arthritis in Colombia with the option for open-label use of the medication for up to one year for all participants. Our central hypothesis is that methotrexate will significantly decrease chronic CHIKV arthritis disease severity compared to placebo via suppression of leukocyte accumulation in synovial tissue and decreased expression of inflammatory cytokines from synovial macrophages and fibroblast-like synoviocytes (FLS).
Timeline
- Start
- 2023-07-18
- Primary completion
- 2027-08-30
- Completion
- 2027-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 15 mg | Oral |
| Subject | Methotrexate | Small molecule | 20 mg | Oral |
Indications
No indication recorded.