What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis (RA) include NSAIDs, glucocorticoids, and DMARDs such as methotrexate. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and renal problems. Glucocorticoids may lead to weight gain, osteoporosis, hypertension, and increased infection risk. Methotrexate, a widely used DMARD, can cause liver toxicity, bone marrow suppression, and interstitial lung disease. The trial for 2-HOBA aims to assess its safety and tolerability, which are crucial given the side effects associated with existing RA treatments.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of Rheumatoid Arthritis, particularly those targeting inflammatory pathways. Anti-TNF agents like golimumab and other monoclonal antibodies such as ofatumumab have been approved for patients with inadequate responses to methotrexate. These treatments aim to reduce inflammation and slow disease progression. While 2-HOBA is being studied for its unique mechanism of scavenging isoLG-adducts, it is part of a broader effort to explore novel therapeutic targets in RA management.

What other types of research exist?

Promising novel alternatives to 2-HOBA for rheumatoid arthritis patients include: <ol> <li>Isoquinoline analogues, which have shown antioxidant and anti-inflammatory activity.</li> <li></li> </ol> Substituted 2-amino thiazole analogues, particularly compound 2m and 3f, which target 5-lipoxygenase and exhibit anti-inflammatory properties. 3. Tetrahydroisoquinoline derivatives, such as compound 21, which have demonstrated antioxidative and anti-inflammatory effects. These compounds could be considered for further investigation and potential use in RA treatment.

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2-HOBA for Rheumatoid Arthritis

Phase 2

Recruiting

Led By Michelle Ormseth, MD, MSCI

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

≥ 4 tender or swollen joints

Must not have

Active infection

Major surgery in ≤ 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 weeks

Summary

This trial is testing a new treatment called 2-HOBA for people with rheumatoid arthritis. 2-HOBA helps to clean up harmful chemicals produced by stress in the body, which can cause inflammation and damage. The goal is to see if this treatment is safe and effective in reducing inflammation and heart disease risk in these patients.

Who is the study for?

Adults diagnosed with Rheumatoid Arthritis who meet specific criteria and haven't changed their arthritis medications in the last 4 weeks can join. They must not have other autoimmune diseases, recent major surgery, active cancer (except certain skin cancers), or serious infections. Participants should not be pregnant, breastfeeding, or have severe liver/kidney issues.

What is being tested?

The trial is testing the safety and effects of a compound called 2-HOBA (750mg taken three times daily) versus a placebo over four weeks on patients with rheumatoid arthritis. It will measure changes in inflammation markers and disease activity.

What are the potential side effects?

Potential side effects are not specified but will include any adverse events related to taking either 2-HOBA or placebo as well as changes in blood pressure and joint tenderness/swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have 4 or more tender or swollen joints.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an infection.

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I have not had major surgery in the last 3 months.

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My kidneys are not working well (creatinine clearance <30 ml/min).

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I have liver cirrhosis or my liver tests are higher than normal.

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I am currently taking an MAO inhibitor.

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I have active cancer, not including non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cellular isolevuglandin (isoLG) adducts

Safety/Tolerability (adverse events)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 2-HOBAExperimental Treatment1 Intervention

2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo (provided as three capsules) three times per day for 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2-(aminomethyl)phenol

Not yet FDA approved

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Rheumatoid Arthritis (RA) include NSAIDs, which reduce inflammation and pain by inhibiting cyclooxygenase enzymes; glucocorticoids, which suppress the immune response and inflammation; and DMARDs like methotrexate, which inhibit folate metabolism to reduce immune activity. Biologics such as TNF inhibitors block tumor necrosis factor, a cytokine involved in systemic inflammation, while JAK inhibitors interfere with the Janus kinase pathways that contribute to immune cell activity. The investigational drug 2-HOBA targets isoLG-adducts, which are involved in oxidative stress and inflammation. Understanding these mechanisms helps RA patients and their doctors choose treatments that best target the underlying processes of their disease, potentially improving outcomes and reducing side effects.