COMPLETED

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis

Quick Facts

Study Start:2022-08-09
Study Completion:2025-05-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05274243

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent
  2. * Age ≥18 years
  3. * Meets 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid Arthritis classification criteria
  4. * ≥ 4 tender or swollen joints
  5. * No change in DMARDs, glucocorticoids in ≥ 4 weeks
  6. * 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)
  7. * 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
  1. * Pregnant or breastfeeding
  2. * Active cancer except non-melanoma skin cancer
  3. * Active infection
  4. * Concomitant inflammatory autoimmune disease
  5. * Major surgery in ≤ 3 months
  6. * Aspirin allergy
  7. * Use of MAO-I
  8. * Estimated creatinine clearance \<30 ml/min
  9. * 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

Contacts and Locations

Principal Investigator

Michelle Ormseth, MD, MSCI
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-09
Study Completion Date2025-05-28

Study Record Updates

Study Start Date2022-08-09
Study Completion Date2025-05-28

Terms related to this study

Keywords Provided by Researchers

  • Rheumatoid Arthritis

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis