Clinical Trial

Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH)

Active, Not Recruiting Phase 3
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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).
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2020-07-20; most recent amendment 2025-12-04.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-12-01
Status change: Recruiting → Enrolling by Invitation 2023-07-20
Status change: Not Yet Recruiting → Recruiting 2023-07-12
Trial Details
NCT Number NCT04483466
Lead Sponsor George Washington University
Conditions Investigate the Effect(s) of Methotrexate Treatment on Arthritis Disease Severity
Enrollment 150 participants
Start Date 2023-07-18
Primary Completion 2027-08-30 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-11