NCT05274243CompletedPhase 2
2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 1 Mar 2022
- Start date
- 9 Aug 2022
- Primary completion date
- 28 May 2025
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05274243
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 32
- From 9 Aug 2022 to the primary completion date, 28 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant inflammatory autoimmune disease
- Major surgery in ≤ 3 months
Other illness
- Active cancer except non-melanoma skin cancer
- Active infection
- Aspirin allergy
Lab values
- 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
Other
- Pregnant or breastfeeding
- Use of MAO-I
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.