Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04483466
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-08-22
First Post:
2020-06-23
Brief Title:
Methotrexate Treatment of Arthritis Caused by Chikungunya Virus MARCH
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
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:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n100 versus placebo n50 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 mouthweek with optional for increase up to 20mgweek 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 mouthweek 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
In the control group participants will receive placebo methotrexate tablets by mouthweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None