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Disulfiram in Rheumatoid Arthritis

ConditionsRheumatoid ArthritisInflammationObesity
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Oklahoma

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: DisulfiramExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability of Disulfiram

Safety and tolerability will be assessed by the frequency, severity, and relatedness of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0), as well as laboratory abnormalities, vital signs, and patient-reported outcomes.

Time frame
Baseline through Week 12

Secondary outcomes

1

Change in Rheumatoid Arthritis Disease Activity (CDAI)

Change in Clinical Disease Activity Index (CDAI) score from baseline to Week 12.

Time frame
Baseline and Week 12
2

Change in Rheumatoid Arthritis Disease Activity (DAS28-CRP)

Change in Disease Activity Score using 28 joints with C-reactive protein (DAS28-CRP) from baseline to Week 12.

Time frame
Baseline and Week 12
3

Change in Insulin Resistance (HOMA-IR)

Change in insulin resistance as measured by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from baseline to Week 12.

Time frame
Baseline and Week 12
4

Change in Body Composition

Change in body composition parameters (fat mass and lean mass) assessed by dual-energy X-ray absorptiometry (DEXA) from baseline to Week 12.

Time frame
Baseline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Presbyterian Health Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: