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2-HOBA for Rheumatoid Arthritis
Phase 2
Recruiting
Led By Michelle Ormseth, MD, MSCI
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
≥ 4 tender or swollen joints
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to treat rheumatoid arthritis. The goal is to find out if it is safe and effective. Up to 32 people will be given the drug or a placebo. The study will last for 4 weeks.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not specified but will include any adverse events related to taking either 2-HOBA or placebo as well as changes in blood pressure and joint tenderness/swelling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have 4 or more tender or swollen joints.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cellular isolevuglandin (isoLG) adducts
Safety/Tolerability (adverse events)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 2-HOBAExperimental Treatment1 Intervention
2-HOBA acetate (2-Hydroxybenzlamine acetate) 750mg (provided as three 250mg capsules) three times per day for 4 weeks
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo (provided as three capsules) three times per day for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
2-(aminomethyl)phenol
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,160 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
22 Patients Enrolled for Rheumatoid Arthritis
Michelle Ormseth, MD, MSCIPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an infection.I haven't changed my arthritis medication in the last 4 weeks.I have not had major surgery in the last 3 months.I have liver cirrhosis or my liver tests are higher than normal.My kidneys are not working well (creatinine clearance <30 ml/min).I am currently taking an MAO inhibitor.I have active cancer, not including non-melanoma skin cancer.I am 18 years old or older.I am willing to stop taking NSAIDs 2 weeks before and during the study.I have 4 or more tender or swollen joints.I haven't changed my arthritis medication in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: 2-HOBA
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of this research endeavor in terms of participant numbers?
"Confirmed. Details available on clinicaltrials.gov suggest that this medical study continues to recruit participants, having been initially posted on August 9th 2022 and last updated September 27th 2022. 32 people are needed from 1 site for the trial's completion."
Answered by AI
What consequences might patients face when exposed to 2-HOBA?
"With only some safety data available, the 2-HOBA drug received a score of two on our team's risk assessment scale. This trial is a phase two study which implies that no efficacy data has been collected yet."
Answered by AI
Are the enlistment protocols for this research still open?
"This study, which was first made public on August 9th 2022 is actively seeking participants. The information posted has been most recently revised as of September 27th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Arizona
Other
New York
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Vanderbilt University Medical Center
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