# Methotrexate treatment of Arthritis caused by Chikungunya virus (MARCH): A randomized controlled trial of methotrexate versus placebo in the treatment of chronic arthritis after chikungunya infection

> **NIH NIH U01** · GEORGE WASHINGTON UNIVERSITY · 2023 · $1,492,743

## Abstract

ABSTRACT
Chikungunya virus (CHIKV) is an alphavirus spread by mosquitos that causes persistent arthritis in
approximately 25% of people two years after initial infection. There is currently no standard evidence-based
treatment for CHIKV chronic arthritis. The French guidelines suggest the use of methotrexate in the treatment
of chronic CHIKV arthritis however there are no randomized placebo-controlled trials of methotrexate to
support this recommendation. Our long-term goal is to guide the evidence-based treatment of CHIKV arthritis.
The main goal of this proposal is to determine the efficacy and histopathologic effects of 6 months of
methotrexate (n=100) versus placebo (n=50) on synovitis in chronic CHIKV arthritis in Colombia in a
randomized controlled trial. Our central hypothesis is that methotrexate will significantly decrease chronic
CHIKV arthritis disease severity compared to placebo and suppress leukocyte accumulation and inflammatory
cytokine expression in synovial tissue. This hypothesis will be evaluated in 2 specific aims. In Aim 1, we will
determine the efficacy of oral methotrexate treatment versus placebo for 6 months in chronic CHIKV arthritis.
In Aim 2, we will determine the effect of methotrexate on synovial inflammation by obtaining synovial biopsy
samples before and during treatment. Rationale: This work will define the role and mechanism of
methotrexate in the treatment of chronic CHIKV arthritis with the goal of advancing the field towards an
evidence-based standard treatment. The potential broader impact of this work is the potential identification of
the pathologic mechanism of chronic viral arthritis and a possible therapeutic option.

## Key facts

- **NIH application ID:** 10693136
- **Project number:** 5U01AR079717-02
- **Recipient organization:** GEORGE WASHINGTON UNIVERSITY
- **Principal Investigator:** Aileen Chang
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,492,743
- **Award type:** 5
- **Project period:** 2022-09-01 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10693136

## Citation

> US National Institutes of Health, RePORTER application 10693136, Methotrexate treatment of Arthritis caused by Chikungunya virus (MARCH): A randomized controlled trial of methotrexate versus placebo in the treatment of chronic arthritis after chikungunya infection (5U01AR079717-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10693136. Licensed CC0.

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