Disulfiram in Rheumatoid Arthritis

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT07534332
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Matching placebo will be administered orally once daily for 12 weeks. The placebo will be identical in appearance, packaging, and labeling to disulfiram to maintain blinding.
  • Disulfiram (DSF) — DRUG
    Disulfiram will be administered orally at a dose of 250 mg once daily for 12 weeks.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Disulfiram
    Participants will receive disulfiram 250 mg orally once daily for 12 weeks in addition to stable background disease-modifying antirheumatic drug (DMARD) therapy.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo orally once daily for 12 weeks in addition to stable background disease-modifying antirheumatic drug (DMARD) therapy.

Primary Outcome Measure

Safety and Tolerability of Disulfiram [ Time Frame: Baseline through Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health CampusOklahoma CityOklahoma73104
Natalie Feland, MPH, BSN, RN
[email protected]
405-271-3480
Beatriz Y Hanaoka, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oklahoma City, OK

By condition
Obesity / overweightRheumatoid arthritis
By specialty
EndocrinologyMetabolic healthWeight lossRheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Oklahoma Health Campus· Oklahoma City, OK

Related Studies