Disulfiram for Joint Inflammation in Overweight Adults With Rheumatoid Arthritis
Tests disulfiram against placebo in overweight adults with active rheumatoid arthritis.
Key facts
- Who runs it
- University of Oklahoma
- Where
- Oklahoma City, United StatesSee the site
- Trial code
- Registry title
- Disulfiram in Rheumatoid Arthritis
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 20 people, planned
- Started
- Sept 2026
- Expected to end
- 30 Apr 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Placebo
- Disulfiram (DSF)
- Record updated
- 27 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active rheumatoid arthritis who are overweight or obese and already take a stable arthritis medicine. It tests disulfiram against placebo for 12 weeks.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Rheumatoid arthritis with active disease (CDAI above 10). Body mass index (BMI) of 25 kg/m² or more.
- Earlier treatment
- Must have been on stable DMARD therapy for at least 3 months before joining.
Main reasons for not taking part
- Significant liver problems (ALT or AST above 2.5 times the upper limit of normal) or liver cirrhosis
- Current or recent alcohol dependence
- Pregnancy or breastfeeding
- Diabetes, hypothyroidism, other autoimmune diseases, or active or chronic infections
- Severe heart disease, severe mental illness, nerve disorders, or kidney disease
The registry criteria, word for word
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Who can take part
- Age 18-75 years Body mass index (BMI) ≥25 kg/m² Diagnosis of rheumatoid arthritis (RA) according to ACR/EULAR classification criteria Active disease defined as Clinical Disease Activity Index (CDAI) >10 Stable disease-modifying antirheumatic drug (DMARD) therapy for ≥3 months prior to enrollment Willingness to abstain from alcohol for the duration of the study Ability and willingness to comply with study procedures
- -
Who cannot take part
- Significant liver dysfunction (ALT or AST >2.5× upper limit of normal) Current or recent alcohol dependence (based on screening, e.g., AUDIT) Known hypersensitivity to disulfiram or other thiuram derivatives Pregnancy or breastfeeding Severe cardiovascular disease (e.g., myocardial infarction, arrhythmia, coronary occlusion) Severe psychiatric illness (e.g., psychosis, suicidal ideation) Neurologic disorders (e.g., epilepsy, peripheral neuropathy, cerebral damage) Chronic or acute renal disease (e.g., nephritis) Hepatic cirrhosis or hepatic insufficiency Use of contraindicated medications (e.g., metronidazole, phenytoin, paraldehyde, alcohol-containing preparations, warfarin) Other autoimmune diseases or active/chronic infections Diabetes mellitus or hypothyroidism Allergy to topical iodine Any condition that, in the opinion of the investigator, would pose undue risk or interfere with study participation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- University of Oklahoma Health CampusOklahoma City, United StatesContact: Natalie Feland, MPH, BSN, RNNot yet recruiting
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- DisulfiramTreatment being tested
Participants will receive disulfiram 250 mg orally once daily for 12 weeks in addition to stable background disease-modifying antirheumatic drug (DMARD) therapy.
Treatment: Disulfiram (DSF)
- PlaceboPlacebo, for comparison
Participants will receive matching placebo orally once daily for 12 weeks in addition to stable background disease-modifying antirheumatic drug (DMARD) therapy.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Therapeutic Targeting of Gasdermin D-Mediated Pyroptosis to Attenuate Joint Inflammation in Rheumatoid Arthritis
- Plain-language title
- Disulfiram for Joint Inflammation in Overweight Adults With Rheumatoid ArthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07534332, who can take part
- Record updated
- 27 July 2026