Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH)
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|ClinicalTrials.gov Identifier: NCT04483466|
Recruitment Status : Not yet recruiting
First Posted : July 23, 2020
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Investigate the Effect(s) of Methotrexate Treatment on Arthritis Disease Severity||Drug: Methotrexate Drug: Placebo||Phase 3|
- In the treatment group, participants will receive methotrexate 15mg by mouth/week with optional for increase up to 20mg/week 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 mouth/week with faux increase optional in non-responders and folic acid 1mg by mouth daily for six months in Phase I.
- In Phase II, any patient may elect to stop taking the study drug or transition to open label active treatment group for the following six months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||Double (Participant, Investigator)|
|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|
|Estimated Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||July 30, 2025|
|Estimated Study Completion Date :||December 30, 2025|
Experimental: Treatment with methotrexate
134 participants will be treated with methotrexate
Methotrexate is vibrant yellow-orange colored powder with physical properties of near insolubility in water formulated into methotrexate tablets containing an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate and are round, convex, and yellow. The chemical name is N-[4-[[(2,4-diamino-6pteridinyl)methyl]methyl amino]benzoyl]-L-glutamic acid. Methotrexate is an anti-metabolite that is a folate antagonist that inhibits lymphocyte proliferation and functions as an immunosuppressant in arthritis.
Placebo Comparator: Placebo methotrexate
76 will receive placebo
- Efficacy of oral methotrexate treatment versus placebo for 6 months in chronic CHIKV arthritis. [ Time Frame: up to 6 months ]An improvement in the American College of Rheumatology (ACR 20) response. The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). For the purposes of our study we will use the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measured by the Health Assessment Questionnaire (HAQ)], visual analog pain scale, C-reactive protein (CRP).
- Inflammation in the synovial tissue measured by synovial inflammatory cell infiltration [ Time Frame: Up to 6 weeks ]The investigators hypothesize that treatment with methotrexate versus placebo will decrease synovial macrophage and T-cell accumulation.
- Inflammatory cytokine levels in synovial tissue [ Time Frame: Up to 6 weeks ]The investigators hypothesize that treatment with methotrexate versus placebo will dampen production of pathogenic cytokines like with TNF, IL-6, and MCP-1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483466
|Contact: Aileen Chang, MD, MSPHemail@example.com|
|Contact: Holly Liu, MBA, MSfirstname.lastname@example.org|