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Methotrexate treatment of Arthritis caused by Chikungunya virus (MARCH): A randomized controlled trial of methotrexate versus placebo in the treatment of chronic arthritis after chikungunya infection

Award Number: U01AR079717
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 02/29/2028

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Methotrexate treatment of Arthritis caused by Chikungunya virus (MARCH): A randomized controlled trial of methotrexate versus placebo in the treatment of chronic arthritis after chikungunya infection - ABSTRACT Chikungunya virus (CHIKV) is an alphavirus spread by mosquitos that causes persistent arthritis in approximately 25% of people two years after initial infection. There is currently no standard evidence-based treatment for CHIKV chronic arthritis. The French guidelines suggest the use of methotrexate in the treatment of chronic CHIKV arthritis however there are no randomized placebo-controlled trials of methotrexate to support this recommendation. Our long-term goal is to guide the evidence-based treatment of CHIKV arthritis. The main goal of this proposal is to determine the efficacy and histopathologic effects of 6 months of methotrexate (n=100) versus placebo (n=50) on synovitis in chronic CHIKV arthritis in Colombia in a randomized controlled trial. Our central hypothesis is that methotrexate will significantly decrease chronic CHIKV arthritis disease severity compared to placebo and suppress leukocyte accumulation and inflammatory cytokine expression in synovial tissue. This hypothesis will be evaluated in 2 specific aims. In Aim 1, we will determine the efficacy of oral methotrexate treatment versus placebo for 6 months in chronic CHIKV arthritis. In Aim 2, we will determine the effect of methotrexate on synovial inflammation by obtaining synovial biopsy samples before and during treatment. Rationale: This work will define the role and mechanism of methotrexate in the treatment of chronic CHIKV arthritis with the goal of advancing the field towards an evidence-based standard treatment. The potential broader impact of this work is the potential identification of the pathologic mechanism of chronic viral arthritis and a possible therapeutic option.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,054,927 )
2026	2026	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	4	3/10/2026	NON-COMPETING CONTINUATION	$1,054,927
														Subtotal = $1,054,927

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	003	3	4/17/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	005	3	9/15/2025	NON-COMPETING CONTINUATION	$0
2025	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	3	4/17/2025	NON-COMPETING CONTINUATION	$0
2025	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	11/20/2024	NON-COMPETING CONTINUATION	$0
2025	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	004	3	9/12/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	11/21/2024	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,694,780 )
2024	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	003	3	9/20/2024	NON-COMPETING CONTINUATION	$0
2024	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	3	9/11/2024	NON-COMPETING CONTINUATION	$1,546,361
2024	2024	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	002	3	9/13/2024	SUPPLEMENT FOR EXPANSION	$148,419
2024	2023	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	3/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,694,780

Issue Date FY: 2023 ( Subtotal = $1,752,413 )
2023	2023	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	9/1/2023	NON-COMPETING CONTINUATION	$1,492,743
2023	2023	GEORGE WASHINGTON UNIVERSITY (THE)	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	2	9/21/2023	SUPPLEMENT FOR EXPANSION	$259,670
														Subtotal = $1,752,413

Issue Date FY: 2022 ( Subtotal = $1,588,967 )
2022	2022	GEORGE WASHINGTON UNIVERSITY, THE	1918 F ST NW	WASHINGTON	DC	20052	DISTRICT OF COLUMBIA	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	8/30/2022	NEW	$1,588,967
														Subtotal = $1,588,967

Grand Total All Awards = $6,091,087

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Methotrexate treatment of Arthritis caused by Chikungunya virus (MARCH): A randomized controlled trial of methotrexate versus placebo in the treatment of chronic arthritis after chikungunya infection

Award Number: U01AR079717

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 02/29/2028

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