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Clinical Trial 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).


Clinical Trial Description

- In the treatment group, participants will receive methotrexate 15mg by mouth/week with optional for increase up to 20mg/week in non-responders and folic acid 1mg by mouth daily for six months in Phase I. - In the control group, participants will receive placebo methotrexate tablets by mouth/week with faux increase optional in non-responders and folic acid 1mg by mouth daily for six months in Phase I. - In Phase II, patients may elect to stop taking the study drug or in those without clinical remission transition to open label active treatment group for the following six months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04483466
Study type Interventional
Source George Washington University
Contact
Status Enrolling by invitation
Phase Phase 3
Start date July 18, 2023
Completion date August 30, 2027