CLINICAL TRIAL

PRV-3279 for Safety and Efficacy

Grade I
Recruiting · 18+ · All Sexes · Tampa, FL

PRV-3279-2a Trial in Systemic Lupus

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About the trial for Safety and Efficacy

Treatment Groups

This trial involves 2 different treatments. PRV-3279 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 2 and have already been tested with other people.

Experimental Group 1
PRV-3279
BIOLOGICAL
Experimental Group 2
Placebo
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A diagnosis of SLE for at least 6 months prior to the Screening visit
Meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for SLE at Screening
At screening: hSLEDAI score ≥6 (≥4 points of which must come from non-serological finding), OR at least one BILAG A or one B score; At randomization: ≥4-point drop in hSLEDAI, OR one BILAG letter grade improvement in at least one A or B score present at Screening, and investigator or central adjudication committee (CAC) rating of definite improvement or major or complete improvement
Able and willing to stop all lupus treatments, except antimalarials, corticosteroids (prednisone equivalent ≤ 10 mg), and NSAIDs
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 32 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 32 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 32 weeks.
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 PRV-3279 will improve 1 primary outcome and 2 secondary outcomes in patients with Safety and Efficacy. Measurement will happen over the course of 24 weeks.

To evaluate whether PRV-3279 prolongs the duration of disease amelioration induced by corticosteroids
24 WEEKS
Time to treatment failure
24 WEEKS
To evaluate the ability of PRV-3279 to prevent flare, defined by LFA international consensus definition of flare, worsening on CGIC, and increase in hSLEDAI/BILAG scores
24 WEEKS
A flare is defined according to LFA international consensus definition of flare, worsening on Clinician's Global Impression of Change (CGIC), increases in hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)/British Isles Lupus Assessment Group (BILAG) Index scores
24 WEEKS
To evaluate the safety of PRV-3279
32 WEEKS
Frequency of TEAEs, SAEs, TEAEs leading to drug withdrawal, AESIs
32 WEEKS

Patient Q & A Section

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

Can safety and efficacy be cured?

Safety and efficacy do not in principle contradict. Whether or not there is a real trade-off between safety and efficacy is determined by the level of efficacy desired, the quality of efficacy expected, and the level of safety expected. If this is achieved with adequate levels of efficacy, safety is achievable.

Anonymous Patient Answer

What causes safety and efficacy?

There was no proof of benefit. Only some small, weak and negative signals suggest that some of the claims of effectiveness are true, though they are all not conclusive. These studies need to be carefully and objectively interpreted before making any recommendation.

Anonymous Patient Answer

What is safety and efficacy?

This analysis shows that there are substantial differences in the quality of meta-analyses that include RCTs for different therapeutic agents. Better standards of meta-analysis reporting are needed to ensure the inclusion of high-quality studies in research and practice.

Anonymous Patient Answer

How many people get safety and efficacy a year in the United States?

Around 80 million Americans have side effects of medicines or of medical devices. In spite of this, medical devices are routinely implanted in 25 million Americans. The number of individuals with safety or efficacy problems will increase as medical devices and drugs become more complex. If safety and efficacy is to be a real concern, we need to educate the public and medical professionals about this issue and strengthen the national patient safety organization.

Anonymous Patient Answer

What are the signs of safety and efficacy?

No clear or consistent signs of safety or efficacy in the acute phase were determined in this study. Further examination of the signs of adverse events should continue.

Anonymous Patient Answer

What are common treatments for safety and efficacy?

Many therapies for safety and efficacy are not widely used for common conditions, because evidence of effectiveness is limited. More research is needed to determine the safety and efficacy of the common treatments for these conditions.

Anonymous Patient Answer

Who should consider clinical trials for safety and efficacy?

The authors argue that when an individual is the target population, then only a small proportion would qualify. However, if an entire population were the target for clinical trials, then the value of clinical trials becomes obvious. For instance, it may take ten years to establish effectiveness or lack of it for a new drug, but there is no doubt about its value if patients, especially those at risk, find it effective. Clinical trials provide valuable data about both efficacy and safety. In addition, it is an opportunity to evaluate adverse effects, some of which can be very unpleasant and difficult to identify. As well as providing information on efficacy, participants in clinical trials can gain confidence in their treatment.

Anonymous Patient Answer

Has prv-3279 proven to be more effective than a placebo?

It was more effective than a placebo for reducing VAS scores in patients infected with HCV genotype 1 or 4. However, the clinical relevance of this result is unknown. The drug is also better tolerated than a placebo. Moreover, an indirect comparison suggests that the efficacy of prv-3279 and daclatasvir may be similar, but prv-3279 is better tolerated. Further large-scale randomized studies are warranted to confirm these results.

Anonymous Patient Answer

What are the latest developments in prv-3279 for therapeutic use?

In the post-marketing period, a large number of new reports have been published regarding P-3279. Although it remains an orphan drug, it may be helpful to understand some of these reports in order to identify the best strategy to use P-3279 in the clinical setting, the most appropriate dosage form for a specific indication, and the safest route of administration.

Anonymous Patient Answer

Is prv-3279 safe for people?

The data from a post-marketing surveillance study support earlier findings of a favourable safety profile with the use of PF-003279 in patients with moderate to severe Crohn's/ulcerative colitis as well as patients with treatment-naïve Crohn's/ulcerative colitis. Findings from a recent study of the large phase II study were published in 2013.

Anonymous Patient Answer

What is prv-3279?

After 2 years of use in subjects with diabetes who met all study entry criteria, varenicline showed a clinically insignificant change in HbA1c. This was despite its known potential effect on plasma glucose and the fact that varenicline increases HbA1c in subjects without diabetes.

Anonymous Patient Answer

Have there been other clinical trials involving prv-3279?

Although the data presented here provide preliminary evidence of antitumor activity in prv-3279, the lack of complete documentation of the adverse effects and the short duration of the study suggest that further preclinical studies are warranted.

Anonymous Patient Answer
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