Testing 2-HOBA for treating rheumatoid arthritis
2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
This study is testing if a new treatment called 2-HOBA can help people with rheumatoid arthritis feel better and manage their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05274243 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial evaluates the tolerability, safety, and effects of 2-HOBA on isoLG-adducts in patients with rheumatoid arthritis. Up to 32 participants will be randomly assigned to receive either 750mg of 2-HOBA or a matching placebo three times daily for four weeks. The primary outcomes include assessing tolerability, adverse events, and changes in isoLG adducts, while exploratory outcomes will focus on inflammation markers, DAS28 scores, and blood pressure. This pilot study aims to inform future research on the efficacy of 2-HOBA in managing rheumatoid arthritis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the classification criteria for rheumatoid arthritis and have active disease.
Not a fit: Patients with active cancer, other inflammatory autoimmune diseases, or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients with rheumatoid arthritis that targets inflammation and cardiovascular risk.
How similar studies have performed: Previous studies have shown promise with similar approaches targeting isoLGs, but this specific application of 2-HOBA is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Age ≥18 years * Meets 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid Arthritis classification criteria * ≥ 4 tender or swollen joints * No change in DMARDs, glucocorticoids in ≥ 4 weeks * If of childbearing potential, willingness to use effective birth throughout study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device) * If using non-steroidal anti-inflammatory drugs (NSAIDs), willingness to discontinue use of NSAIDs for 2 weeks prior to the study and throughout the study Exclusion Criteria: * Pregnant or breastfeeding * Active cancer except non-melanoma skin cancer * Active infection * Concomitant inflammatory autoimmune disease * Major surgery in ≤ 3 months * Aspirin allergy * Use of MAO-I * Estimated creatinine clearance \<30 ml/min * Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \>1.5x the upper limit of normal or total bilirubin ≥1.5 mg/dl
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Ormseth, MD, MSCI — Vanderbilt University Medical Center
- Study coordinator: Phicharmon Kulapatana, MD
- Email: phicharmon.kulapatana@vumc.org
- Phone: 615-322-4746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.