2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

Description

This is a phase 2 study to determine 2-HOBA's tolerability, safety, and effect on isoLG-adducts in patients with rheumatoid arthritis (RA) patients. Up to 32 subjects will be randomized to 750mg 2-HOBA or matching placebo three times a day for 4 weeks. As primary outcome measures investigators will compare tolerability and adverse events and changes in isoLG adducts in active and placebo arms. Among prespecified exploratory outcomes investigators will compare changes in markers of inflammation, DAS28 score, and 24-hour blood pressure in active and placebo arms. This pilot study will inform the feasibility and design of future studies to examine the efficacy of 2-HOBA in RA patients.

Conditions

Rheumatoid Arthritis

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Study Overview

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Study Details

Study overview

This is a phase 2 study to determine 2-HOBA's tolerability, safety, and effect on isoLG-adducts in patients with rheumatoid arthritis (RA) patients. Up to 32 subjects will be randomized to 750mg 2-HOBA or matching placebo three times a day for 4 weeks. As primary outcome measures investigators will compare tolerability and adverse events and changes in isoLG adducts in active and placebo arms. Among prespecified exploratory outcomes investigators will compare changes in markers of inflammation, DAS28 score, and 24-hour blood pressure in active and placebo arms. This pilot study will inform the feasibility and design of future studies to examine the efficacy of 2-HOBA in RA patients.

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Michelle Ormseth, MD, MSCI, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2025-03