Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH) (NCT04483466) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH)
Colombia150 participantsStarted 2023-07-18
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated informed consent form.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Male or female, aged \>18 years
. Ability to take oral medication and be willing to adhere to the methotrexate regimen
. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the end of methotrexate administration.
. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of oral methotrexate treatment versus placebo for 6 months in chronic CHIKV arthritis.
. Have a diagnosis of CHIKV by CHIKV IgM or IgG antibody.
. The disease duration should be greater than 3 months (based on onset of symptoms).
Exclusion criteria
. Pregnancy or lactation
. Known allergic reactions to components of methotrexate or folic acid.
. Treatment with another investigational drug or other intervention within 1 month.
. History of chronic infection such as hepatitis and HIV. Patients with acute infection will have enrollment deferred until the infection resolves.
. Current signs or symptoms of uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
. Patients with a current diagnosis of class III or IV CHF.
. History of lymphoproliferative disease including lymphoma.
. Overt or laboratory evidence of immunodeficiency syndromes.