NCT04483466

Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH)

Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH): A Phase III Randomized Controlled Clinical Trial of the Efficacy of Methotrexate Monotherapy in the Treatment of Chronic Arthritis After Chikungunya Infection

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: George Washington University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Investigate the Effect(s) of Methotrexate Treatment on Arthritis Disease Severity

Interventions

Type	Name	Description
DRUG	Methotrexate	Methotrexate is vibrant yellow-orange colored powder with physical properties of near insolubility in water formulated into methotrexate tablets containing an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate and are round, convex, and yellow. The chemical name is N-\[4-\[\[(2,4-diamino-6pteridinyl)methyl\]methyl amino\]benzoyl\]-L-glutamic acid. Methotrexate is an anti-metabolite that is a folate antagonist that inhibits lymphocyte proliferation and functions as an immunosuppressant in arthritis.
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-07-18
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2020-07-23
• Last updated: 2025-12-11

Locations

1 site across 1 country: Colombia

Regulatory

• FDA-regulated drug study