CLINICAL TRIAL

SEL-212B for Gout

Refractory
Waitlist Available · 18+ · All Sexes · Jupiter, FL

This study is evaluating whether a drug may help reduce the size of tophi in patients with gout.

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About the trial for Gout

Eligible Conditions
Gout Chronic · Gout

Treatment Groups

This trial involves 3 different treatments. SEL-212B is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
SEL-212B
DRUG
Experimental Group 2
SEL-212A
DRUG
Control Group 3
Normal Saline
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Has negative results of an FDA Emergency Use Authorized COVID-19 molecular assay for detection of SARS-CoV-2 RNA from a nasal or oropharyngeal specimen;
You have gouty arthritis or tophus. show original
a. > 6 weeks after hysterectomy with or without surgical bilateral salpingooperhectony or b. Post-menopausal (> 24 months of natural amenorrhea or in the absence of >24 months of amenorrhea, one documented confirmatory FSH measurement)
Has chronic refractory gout defined as having failed to normalize sUA and whose signs and symptoms are inadequately controlled with any of the xanthine oxidase inhibitors, or for whom these drugs are contraindicated for the patient;
You have a SUA ≥ 7 mg/dL. show original
You have not had a positive serology for HIV-1/-2 or hepatitis B or hepatitis C. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether SEL-212B will improve 1 primary outcome and 5 secondary outcomes in patients with Gout. Measurement will happen over the course of 6 months.

Tender and Swollen Joint Counts
6 MONTHS
To assess changes in number of tender and swollen joints in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
6 MONTHS
HAQ-DI
6 MONTHS
To assess change in Patient Reported Outcomes (PROs) including assessments of: activity limitation (HAQ-DI) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
6 MONTHS
SF-36
6 MONTHS
To assess change in Patient Reported Outcomes (PROs) including assessments of: patients' quality of life (QoL) (SF-36) in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
6 MONTHS
Gout Flare Incidence
6 MONTHS
To assess changes in gout flare incidence in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
6 MONTHS
Serum uric acid control during month 6
6 MONTHS
The percentage of patients who achieve and maintain reduction in serum uric acid (sUA) < 6 mg/dL for at least 80% of the time during month 6 in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
6 MONTHS
Tophus burden
6 MONTHS
To assess change in tophus burden by photographic area assessment in patients with gout refractory to conventional treatment treated with two different dose levels of SEL-212 compared to placebo
6 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of gout?

The signs of gout may include pain, swollen and red joints, or fever and a raised creatinine level. The signs usually last a few days and tend to lessen over several days. It is very rare to have signs all at one time.

Anonymous Patient Answer

How many people get gout a year in the United States?

The number of people with gout increased from about 10 million in 1980 to 18 million in 2001. More than 100,000, or 0.1%, of the gout population are estimated in the US to be hospitalized for gout in a given year. Findings from a recent study may help inform the policy development needed to treat and prevent primary and secondary prevention of gout and the associated comorbidities.

Anonymous Patient Answer

Can gout be cured?

Gout is not a treatable disease. In the past, a long, painful and painful disease of limited duration, it has largely been left to self-palliative measures until now, but since the advent of methotrexate and other successful drugs, the aim of treatment has been to prolong life and reduce the cumulative dose of NSAIDs (by reducing cumulative dose of paracetamol), and to maintain remission in chronic disease. Since, this aims at reducing disease progression and avoiding disability, rather than just preventing the disease. The goal now is to avoid development of erosive joints.

Anonymous Patient Answer

What is gout?

There is a lack of clarity in the scientific literature regarding common or incorrect beliefs about gout that have been described in the public domain.

Anonymous Patient Answer

What are common treatments for gout?

The typical pharmacotherapy is generally supportive to the clinical and functional outcomes associated with the disease. Aspirin is probably the most common medication used for the treatment of gout. Other drugs like colchicine (a drug used in treating gouty arthritis) have shown favourable effects as well.

Anonymous Patient Answer

What causes gout?

The current data demonstrate that a variety of environmental and social factors appear to be associated with an increased risk of gout. Gout occurs when the body's normal way of metabolizing cholesterol and other fat molecules becomes out of balance and produces acidic uric acid. This can occur if the body's metabolism does not adjust quickly enough. Gout occurs most often when there is an underlying medical problem or disease that can cause the body to not be able to metabolize fats correctly.

Anonymous Patient Answer

Does gout run in families?

Gout is largely familial, with the parents often showing gouty symptoms. Findings from a recent study suggests that the primary cause of the clustering of gout in families is the increased prevalence of genetic predisposition to developing gout.

Anonymous Patient Answer

What are the common side effects of sel-212b?

Results from a recent clinical trial of this study do not show any significant difference in side effects between the 2 treatment cohorts at the doses investigated.

Anonymous Patient Answer

Who should consider clinical trials for gout?

Gout, due to its chronic nature and the frequent recurrence of flares, presents a considerable investment of money and time for both the patient and health-care system. Clinicians are sometimes not aware of the long-term costs of recurrent disease. Given the small number of people benefiting from a new treatment, we must consider when and who it is best to evaluate the short- and long-term value of a new medication. These questions depend on many parameters, including how we define "gout", what the time frame is to assess long-term outcomes, the cost of alternative therapies for treating gout, and how much value we place on quality of life.

Anonymous Patient Answer

What is the latest research for gout?

The latest research in this area has been quite limited. However, the most recent one is that hyperuricemia increases the risk of gout. Most importantly, there has been a study showing that allopuridine (a purine analogue) is an effective treatment for gout, especially in gout patients with hyperuricemia. Another treatment strategy is that the combination of allopurazine and colchicine is very effective in gout patients with hyperuricemia.

Anonymous Patient Answer

How does sel-212b work?

At low doses, sel-212b is able to reduce inflammation without causing neurotoxicity, as predicted by its known antioxidant action. Sel-212b, with its known effects as an antimutagenic agent, is promising in the treatment of diseases involving oxidative stress, including atherosclerosis, cancer, and other autoimmune diseases.

Anonymous Patient Answer

Have there been other clinical trials involving sel-212b?

Results from a recent clinical trial show that sel-212b can safely be used as a monotherapy to treat patients with severe gout. More studies are needed to identify the specific pharmacological mechanism that is responsible for the clinical benefits observed in this study.

Anonymous Patient Answer
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