Disulfiram for Rheumatoid Arthritis

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Overseen ByNatalie Feland, MPH, BSN, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Oklahoma
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by persistent joint inflammation and systemic immune activation. Obesity is common among individuals with RA and is associated with increased disease activity, reduced treatment response, and worse functional outcomes. Inflammation in adipose tissue, driven in part by activation of the NLRP3 inflammasome and downstream gasdermin D (GSDMD)-mediated pathways, may contribute to systemic inflammation and RA disease severity.

Disulfiram (DSF), an FDA-approved medication for alcohol use disorder, has recently been identified as an inhibitor of GSDMD-mediated inflammatory signaling and pyroptosis. Preclinical studies suggest that DSF reduces inflammasome activation, inflammatory cytokine release, and metabolic dysfunction.

This study is a 12-week, randomized, double-blind, placebo-controlled pilot trial designed to evaluate the safety, tolerability, and preliminary efficacy of DSF in overweight and obese adults with active RA despite stable disease-modifying antirheumatic drug (DMARD) therapy. Participants will be randomized to receive either DSF (250 mg daily) or placebo.

The primary objective is to assess safety and tolerability. Secondary and exploratory objectives include evaluating the effects of DSF on systemic inflammation, RA disease activity, metabolic parameters, and adipose tissue inflammasome activation. Findings from this study will inform the feasibility and design of larger clinical trials targeting GSDMD-mediated inflammation in RA.

Who Is on the Research Team?

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Beatriz Y Hanaoka, MD, MSc

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

Inclusion Criteria

Active disease defined as Clinical Disease Activity Index (CDAI) >10
Willingness to abstain from alcohol for the duration of the study
Ability and willingness to comply with study procedures
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Exclusion Criteria

Current or recent alcohol dependence (based on screening, e.g., AUDIT)
Pregnancy or breastfeeding
Known hypersensitivity to disulfiram or other thiuram derivatives
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What Are the Treatments Tested in This Trial?

Interventions

  • Disulfiram

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: DisulfiramExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Presbyterian Health Foundation

Collaborator