Brentuximab Vedotin for Sclerosis
This study is evaluating whether a drug which targets a protein on immune cells may help treat systemic sclerosis.
See full descriptionAbout the trial for Sclerosis
Treatment Groups
This trial involves 6 different treatments. Brentuximab Vedotin is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
About The Treatment
Side Effect Profile for Brentuximab Vedotin 1.8 mg/kg
Eligibility
This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Brentuximab Vedotin will improve 6 secondary outcomes and 7 other outcomes in patients with Sclerosis. Measurement will happen over the course of From week 0 (≥first dose of assigned treatment) to week 48 post-randomization.
Patient Q & A Section
How does brentuximab vedotin work?
Brentuximab vedotin is a potent chemotherapeutic agent that effectively targets B-cell clones responsible for the pathogenesis of MM. In a recent study, findings provides the first evidence of antitumor activity of brentuximab vedotin against refractory MM.
Has brentuximab vedotin proven to be more effective than a placebo?
There was no significant difference in the time to progression observed in the brentuximab vedotin (BV) group compared to the placebo group or when brentuximab vedotin was combined with everolimus.
Does sclerosis run in families?
There is a slight but significant familial clustering of SSc. Families with a history of a family member affected with SSc have a greater chance of at least one affected family member. Such observations are important to the medical evaluation and genetic counseling of SSc.
What are the signs of sclerosis?
Sclerosis affects all or just part of the body and symptoms can be mild to severe. Examples include arthralgia, dysphagia, skin changes affecting the whole body, or numbness.\n
What are common treatments for sclerosis?
Current treatments for sclerosis are not effective in many cases, and the current treatment options are limited in scope, while the quality of current information is often limited and poor. Future research is needed to identify and understand the factors underlying the failure of current treatments, as well as to develop better and better treatments for diseases such as sclerosis.
How many people get sclerosis a year in the United States?
There is a higher rate of sclerosis among men and whites than among Hispanics, non-Hispanic blacks, and Asians, but not among Hispanics or non-Hispanic blacks. The incidence appears to be increasing.
What causes sclerosis?
Sclerosis may be caused by genetic and environmental factors. On the cellular level, the changes observed indicate inflammation of the arteries as a cause of the lesions. Finally, the role of viruses is still under investigation.
Can sclerosis be cured?
Sclerotic changes are common in the body and brain for reasons unrelated to dementia. In this situation, it remains important to manage cardiovascular risk factors and reduce alcohol intake.
What is sclerosis?
Sclerosis is the formation of scar tissue and excessive cell proliferation leading to loss of normal lung function. Sclerosis mostly takes place in adults, and can be a cause of breathing problems. Symptoms can include worsening shortness of breath, sweating, and chest pain. To help understand the pathology of sclerotic diseases a detailed history is required with a full physical examination. There are many ways to classify the different types of sclerotic diseases. The cause of sclerotic disease is still unknown. Prostate cancer can develop into a harder form of sclerotic disease called benign prostatic hyperplasia.
What are the latest developments in brentuximab vedotin for therapeutic use?
Brentuximab vedotin has been shown to significantly reduce the median PFS compared to [brentuximab] vedotin. Brentuximab vedotin had a safety profile similar to [brentuximab] vedotin, and was well tolerated. The new drug is expected to be well-accepted by the medical community, though it will continue to face competition from [brentuximab] vedotin.
How serious can sclerosis be?
Most patients will not develop SSc complications by their late 50s or early 60s, although a large percentage will develop SSc-related complications even if SSc is detected with less than 90-day latency between the time of symptom onset and the time of diagnosis in most cases.
Have there been other clinical trials involving brentuximab vedotin?
Brentuximab vedotin is currently the only investigational product approved in any country in the United States for any chronic autoimmune disease or cancer treatment in patients who are ineligible for CAR-T cell therapy. The data from the current cohort of 5,000 patients treated in the USA are encouraging, as patients treated on this pathway experience durable, objective responses, with some patients achieving remissions.