Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH)
Status:
Not yet recruiting
Trial end date:
2027-06-30
Target enrollment:
Participant gender:
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).