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 range18 Years
SexALL
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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.
✓. 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
What they're measuring
1
Efficacy of oral methotrexate treatment versus placebo for 6 months in chronic CHIKV arthritis.
✕. 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.