Status:
COMPLETED
2-HOBA Phase 2 Clinical Trial in Rheumatoid Arthritis
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-HOB...
Detailed Description
Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disease affecting 1% of the population. Aggressive treatment is a fundamental therapeutic strategy to improve disease-related outcomes a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05274243
Start Date
August 9 2022
End Date
May 28 2025
Last Update
December 23 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232