CLINICAL TRIAL

ENUMERATION OF CD5+ B Cells for Vasculitis

1 Prior Treatment
Low Risk
Relapsed
Recruiting · 18+ · All Sexes · Chapel Hill, NC

This study is evaluating whether a specific type of white blood cell may help predict the risk of relapse for individuals with a certain type of vasculitis.

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About the trial for Vasculitis

Eligible Conditions
Vasculitis · ANCA-Associated Vasculitis (AAV) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Treatment Groups

This trial involves 3 different treatments. ENUMERATION OF CD5+ B Cells is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
ENUMERATION OF CD5+ B Cells
DEVICE
Control Group 2
ENUMERATION OF CD5+ B Cells
DEVICE
Control Group 3
ENUMERATION OF CD5+ B Cells
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Vasculitis or one of the other 2 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients may be randomly assigned to be ANCA negative or positive. show original
GN caused by an autoimmune disease that involves the inflammation of small blood vessels in the kidneys, as evidenced by a positive test for Myeloperoxidase (MPO) or Proteinase 3 (PR3)-ANCA show original
After three months of therapy with corticosteroids and rituximab (either 1000 mg IV x 2 or 375 mg/m2 IV x 4) or corticosteroids and cyclophosphamide (monthly IV or daily oral doses), patients must be in remission and on no more than 5 mg daily of oral prednisone or equivalent. show original
After the use of alemtuzumab, the number of B cells increased, with 1% of CD19+ cells being B cells show original
This study involved patients aged 18-85. 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: from first negative ANCA test since start of study , if applicable- to end of study, maximum two years, as applicable
Screening: ~3 weeks
Treatment: Varies
Reporting: from first negative ANCA test since start of study , if applicable- to end of study, maximum two years, as applicable
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: from first negative ANCA test since start of study , if applicable- to end of study, maximum two years, as applicable.
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 ENUMERATION OF CD5+ B Cells will improve 1 primary outcome and 6 secondary outcomes in patients with Vasculitis. Measurement will happen over the course of from first negative ANCA test since start of study , if applicable- to end of study, maximum two years, as applicable.

Time to Positive ANCA
FROM FIRST NEGATIVE ANCA TEST SINCE START OF STUDY , IF APPLICABLE- TO END OF STUDY, MAXIMUM TWO YEARS, AS APPLICABLE
for patients who had a negative ANCA test, time to positive ANCA
FROM FIRST NEGATIVE ANCA TEST SINCE START OF STUDY , IF APPLICABLE- TO END OF STUDY, MAXIMUM TWO YEARS, AS APPLICABLE
Frequency of Relapse
FROM COMPLETE REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
frequency, as determined by number of relapse in each group
FROM COMPLETE REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
Severity of Relapse
FROM COMPLETE REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
severity (as determined by BVAS score) of relapse in each group
FROM COMPLETE REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
Time to First Relapse
FROM COMPLETE REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
The primary outcome measure is time to first relapse defined as recurrence of any signs or symptoms attributable to active vasculitis after a period of complete remission, with at least 2 minor or 1 major item on the BVAS score (BVAS≥2). Per protocol, complete remission is defined as a BVAS score = 0. Birmingham Vasculitis Activity Score for Wegener's Granulomatosis(BVAS, range 0-64). The total score is composed of 34 predefined items, units on a scale, grouped into 9 organ systems. Each item carries a weight from 1-3, depending on disease severity. A score of 0 indicates no disease activity; a higher score indicates worsening disease.
FROM COMPLETE REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
Frequency of Infections
FROM REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
number of infections
FROM REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
Number of Infections, categorized by severity
FROM REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
number of mild/moderate/serious infections
FROM REMISSION TO END OF STUDY, APPROXIMATELY 2 YEARS
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Patient Q & A Section

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

Does vasculitis run in families?

A significant number of individuals with familial PV may have severe disease. Identifying risk factors for disease in PV may lead to preventive strategies for high-risk families.

Anonymous Patient Answer

How serious can vasculitis be?

We conclude that the severity of a vasculitic pattern of illness by PAS/C3 and cryoglobulinemia is most pronounced in patients with the anti-GBM subtype of vasculitis and with cryoglobulinemia who are male.

Anonymous Patient Answer

What are common treatments for vasculitis?

The diagnosis of vasculitis is commonly multifactorial and is associated with both medical cost and complications. Treatment in this subset of patients can thus be individualised and focused on the specific cause of each individual's symptoms. Treatment options for vasculitis can be broadly grouped into immunomodulating, anti-viral agents, anti-inflammatory agents, and corticosteroids.

Anonymous Patient Answer

What is vasculitis?

The three most common diseases in the study are vasculitis. Some of the specific types of vasculitis that have been studied are listed below: granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis. Granulomatosis with polyangiitis occurs in approximately 10% of patients with vasculitis. This is a disease that primarily occurs in older adults that causes inflammation in many small, blood vessel-related organs. Microscopic polyangiitis can occur in individuals who have an underlying genetic predisposition.

Anonymous Patient Answer

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

There is no estimate for the number of vasculitis patients a year in the United States. It is estimated that between 524 and 1,098 cases per year occur in the United States.

Anonymous Patient Answer

What causes vasculitis?

In cases of unexplained cutaneous vasculitis, vasculitis with vasculopathy should be considered. Vasculitis of other type should not be treated as vasculitis of some kind. Local vasculitis may be caused by infections, tumours, and allergic systemic vasculitis while systemic vasculitis may be caused by infections and tumours. The cause of some cases of vasculitis remains unknown.

Anonymous Patient Answer

What are the signs of vasculitis?

The vasculitis syndromes are common in primary Sjögren's syndrome. The most common manifestation in patients with primary Sjögren's syndrome is multifocal microangiopathic cutaneous lesions. Microangiopathic cutaneous lesions are often found in patients with systemic lupus erythematosus and granulomatosis with polyangiitis, and the term "NOS" is often used instead of "SLE".

Anonymous Patient Answer

Can vasculitis be cured?

Patients with lupus or polyarteritis nodosa, whose disease is under control, would be expected to revert and relapses are extremely rare in vasculitis. Most of these patients may be in remission with no evidence of active disease on review. If vasculitides were cured, we propose these vasculitides are not "just" inflammatory diseases but in part represent immunological disorders, a hypothesis that needs to be examined in the future.

Anonymous Patient Answer

What is the latest research for vasculitis?

The last 2 years have seen the introduction of novel medications that improve corticosteroid response and prolong steroid-free survival (e.g., tacrolimus, rituximab). The development of biologics including rituximab and anti-TNF drugs, and new drugs that target T-cells (e.g., tocilizumab) are all expected to be released in the next 3 years. The development of novel therapies for the treatment of vasculitis has not slowed in the past 5 years, and it is crucial to have a coherent program of clinical trials to evaluate these agents appropriately.

Anonymous Patient Answer

What are the common side effects of enumeration of cd5+ b cells?

This work showed that enumeration of CD5 B cells in the presence of immunoglobulin G is feasible and reproducible. Oncogenic CD5+ B cells can be enumerated by flow cytometry, and thus this strategy may be useful for clinical diagnosis and for B-cell depletion therapy.

Anonymous Patient Answer

Who should consider clinical trials for vasculitis?

Patients affected by vasculitis should consider participation in clinical trials only when indicated by their physicians, especially when they are in a critical phase of their disease.

Anonymous Patient Answer

What is enumeration of cd5+ b cells?

We show that the absolute number of CD5+B cells in peripheral blood of patients with vasculitis is significantly increased compared to healthy controls and inversely correlated with systemic inflammatory parameters, suggesting a role of the adaptive immune system in the inflammatory process in these settings.

Anonymous Patient Answer
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