2-HOBA for Rheumatoid Arthritis

Recruiting in Palo Alto (17 mi)

Overseen by Michelle J Ormseth, MD, MSCI

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Vanderbilt University Medical Center

Must not be taking: MAO-I, NSAIDs

Disqualifiers: Pregnancy, Cancer, Infection, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. If you are using non-steroidal anti-inflammatory drugs (NSAIDs), you must stop them for 2 weeks before and during the study. There should be no changes in DMARDs or glucocorticoids for at least 4 weeks before the study.

How is the drug 2-HOBA different from other treatments for rheumatoid arthritis?

2-HOBA (2-Hydroxybenzylamine, Hobamine) is unique because it may target oxidative stress, a different mechanism compared to traditional treatments like methotrexate, which primarily suppresses the immune system. This novel approach could offer an alternative for patients who do not respond well to existing therapies.

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Eligibility Criteria

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.

Inclusion Criteria

I haven't changed my arthritis medication in the last 4 weeks.

Written informed consent

If of childbearing potential, willingness to use effective birth control throughout study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device)

Exclusion Criteria

Aspirin allergy

I currently have an infection.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either 750mg 2-HOBA or matching placebo three times a day for 4 weeks

4 weeks

2 visits (in-person at week 0 and week 4)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

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.

Group I: 2-HOBA Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vanderbilt University Medical Center Nashville, TN

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center Lead Sponsor

References

1. Italy pubmed.ncbi.nlm.nih.gov

Heme oxygenase-1 end-products carbon monoxide and biliverdin ameliorate murine collagen induced arthritis. [2017] Heme oxygenase-1 (HO-1) which degrades Heme to free iron, biliverdin and carbon monoxide (CO) plays an important role in inflammation. There are, however, conflicting data concerning the role of HO-1 in rheumatoid arthritis (RA) and the therapeutic potential of individual heme degradation products remains to be determined. We therefore investigated the effect of CO and biliverdin upon therapeutic administration in the murine collagen induced arthritis (CIA) model of RA.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Chebulanin exerts its anti-inflammatory and anti-arthritic effects via inhibiting NF-κB and MAPK activation in collagen-induced arthritis mice. [2021] Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by synovial inflammation and progressive joint destruction. Chebulanin is a natural polyphenol acid isolated from the traditional Tibetan medicine Terminalia chebula Retz that has previously been reported to possess anti-inflammatory properties. The present study aimed to investigate the anti-inflammatory and anti-arthritic effects of chebulanin and explore its underlying mechanisms in vivo and in vitro using a collagen-induced arthritis (CIA) mouse model and lipopolysaccharide (LPS) stimulated RAW264.7 cell inflammation model. Arthritis severity scores were assessed twice weekly; the levels of cytokines interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in serum were detected using enzyme-linked immunosorbent assay kits; histopathological assessment was performed using micro computed tomography and hematoxylin and eosin staining. Activation of nuclear factor kappa B (NF-κB) and mitogen-activated protein kinase (MAPK) signaling pathways were assessed using western blotting. The inhibition of translocation of cytosolic p38 and p65 into the nucleus was observed using immunofluorescence staining and western blotting in vitro. Chebulanin significantly suppressed the progression and development of RA in CIA mice by decreasing the arthritis severity scores, attenuating paw swelling and joint destruction, and reducing the levels of IL-6 and TNF-α significantly (p

3. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of Yishen Tongbi decoction versus methotrexate in patients with active rheumatoid arthritis: A double-blind, randomized, controlled, non-inferiority trial. [2023] Yishen Tongbi decoction (YSTB) which is an herbal formula, has been used for the treatment of rheumatoid arthritis (RA) for more than ten years with a better curative effect. Methotrexate (MTX) is an effective anchoring agent used to treat rheumatoid arthritis. There were, however, no head-to-head comparative randomized controlled trials comparing traditional Chinese medicine (TCM) to MTX, Therefore, we performed this double-blind, double-model, randomized controlled trial of the efficacy and safety of YSTB and MTX in the treatment of active RA for 24 weeks.

4. England pubmed.ncbi.nlm.nih.gov

Comparative study of HO-1 expressing synovial lining cells between RA and OA. [2021] We aimed to clarify the characteristics of heme oxygenase (HO)-1 expressing cells in the synovium from rheumatoid arthritis (RA) and osteoarthritis (OA), and to investigate the co-expression of HO-1 and IgG-Fc/HLA-DR complex.

5. Germany pubmed.ncbi.nlm.nih.gov

Leonurine alleviates rheumatoid arthritis by regulating the Hippo signaling pathway. [2023] Rheumatoid arthritis (RA) is a chronic autoimmune disease that can cause joint inflammation and damage. Leonurine (LE) is an alkaloid found in Leonurus heterophyllus. It has anti-inflammatory effects.