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Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH)

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Feb 28, 2030 to Aug 30, 2027v14
  2. Trial status: Enrolling by Invitation to Active, Not Recruitingv13
  3. Primary and study completion dates: Aug 30, 2027 to Feb 28, 2030v12
  4. Re-verified, no change to tracked fieldsv11
  5. Start date: Jul 4, 2023 to Jul 18, 2023v10
Show 8 earlier versionsHide 8 earlier versions
  1. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v9
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2023 to Jul 4, 2023
    v8
  3. Start date: Mar 1, 2023 to Jun 1, 2023v7
  4. Start date: Dec 1, 2022 to Mar 1, 2023v6
  5. Start date: Sep 1, 2022 to Dec 1, 2022v5
  6. Re-verified, no change to tracked fieldsv4
  7. Start date: Jul 1, 2022 to Sep 1, 2022
    • Primary and study completion dates: Jun 30, 2027 to Aug 30, 2027
    • Eligibility criteria expanded, about 138 words
    • Study description shortened, about 1 word
    v3
  8. Primary completion date: Jul 30, 2025 to Jun 30, 2027v2 Show 5 more changesShow less
    • Start date: Aug 1, 2020 to Jul 1, 2022
    • Enrollment target: 201 to 150
    • Study completion date: Dec 30, 2025 to Jun 30, 2027
    • Eligibility criteria expanded, about 14 words
    • Study description expanded, about 5 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04483466
Lead Sponsor George Washington University
Conditions
(from sponsor)		 Investigate the Effect(s) of Methotrexate Treatment on Arthritis Disease Severity
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov