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CD5+ B Cell Monitoring for Vasculitis

N/A

Waitlist Available

Led By Vimal Derebail, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be in complete remission for at least 1 month and after AT LEAST 3 MONTHS of induction 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). They must be on no more than 5 mg daily of oral prednisone or equivalent. Complete remission is defined as a BVAS score = 0

ANCA Glomerulonephritis (GN) or vasculitis per Chapel Hill Consensus Criteria, with documented current or previously positive Myeloperoxidase (MPO)- or Proteinase 3 (PR3)-ANCA by ELISA test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first negative anca test since start of study , if applicable- to end of study, maximum two years, as applicable

Awards & highlights

Study Summary

This trial is testing whether a certain type of B cell is associated with decreased risk of relapse in ANCA vasculitis, and whether patients with this type of B cell can be monitored conservatively without further immunotherapy.

Who is the study for?

Adults aged 18-85 with ANCA vasculitis, a condition where antibodies damage blood vessels, can join if they've had successful initial treatment and are in remission. They must have some B cells recovered but can't participate if they have certain infections, multiple relapses of vasculitis, or are pregnant.Check my eligibility

What is being tested?

The trial is testing whether patients with ANCA vasculitis who recover a specific type of B cell (CD5+) after initial therapy need ongoing treatment. Some will get more immunotherapy (rituximab), while others will just be closely watched without further medication.See study design

What are the potential side effects?

Rituximab may cause infusion reactions, infections due to immune system suppression, skin rashes, and potentially serious heart problems. Azathioprine and mycophenolate mofetil might lead to similar issues like increased infection risk and liver or bone marrow problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've been in complete remission for over a month after treatment with specific drugs and am on a low dose of steroids.

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I have kidney inflammation or blood vessel inflammation due to ANCA, confirmed by a positive MPO or PR3 test.

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My kidney inflammation is confirmed by biopsy and I tested positive for ANCA.

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My B cells have recovered to a level that allows for further testing.

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I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to end of study, approximately 2.5 to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to end of study, approximately 2.5 to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of study, approximately 2.5 to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to First Relapse

Secondary outcome measures

Frequency of Infections

Frequency of Relapse

Number of Infections, categorized by severity

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: high CD5 / NO maintenanceExperimental Treatment1 Intervention

Subjects in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)

Group II: low CD5+ /on maintenanceActive Control1 Intervention

Subjects in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.

Group III: high CD5/ on maintenanceActive Control1 Intervention

Subjects in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,576 Total Patients Enrolled

2 Trials studying Vasculitis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,201 Total Patients Enrolled

2 Trials studying Vasculitis

Vimal Derebail, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

7 Total Patients Enrolled

Media Library

ENUMERATION OF CD5+ B Cells Clinical Trial Eligibility Overview. Trial Name: NCT03906227 — N/A

Vasculitis Research Study Groups: low CD5+ /on maintenance, high CD5/ on maintenance, high CD5 / NO maintenance

Vasculitis Clinical Trial 2023: ENUMERATION OF CD5+ B Cells Highlights & Side Effects. Trial Name: NCT03906227 — N/A

ENUMERATION OF CD5+ B Cells 2023 Treatment Timeline for Medical Study. Trial Name: NCT03906227 — N/A

Frequently Asked Questions

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

Are there any vacancies for participation in the trial?

"Yes, according to clinicaltrials.gov the trial is actively recruiting volunteers as of today’s date. The study was initially posted on June 28th 2019 and has since been modified November 29th 2021; 40 participants are being sought from a single site."

Answered by AI

Is this clinical study open to minors?

"This clinical trial is available to individuals aged 18-85. For minors and those over 65, there are 6 forms of this medication for the former demographic, and 31 studies open to the latter age group."

Answered by AI

What is the current capacity of this research initiative?

"Affirmative. According to records on clinicaltrials.gov, this medical experiment is currently recruiting volunteers and has been since June 28th 2019. The study seeks 40 subjects from a solitary site and was last updated November 29th 2021."

Answered by AI

Is it possible to participate in this medical study?

"This clinical study is enrolling 40 individuals with anti-neutrophil cytoplasmic antibody-associated vasculitis, ranging from 18 to 85 in age. To qualify for the trial, patients must have been in full remission for a month and had at least 3 months of induction therapy with corticosteroids and rituximab/cyclophosphamide while taking no more than 5 mg daily of oral prednisone or its equivalent. Additionally, applicants may be ANCA negative or positive when entering the trial."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Rituximab Versus Azathioprine for Maintenance in Anca-associated Vasculitis

Guillevin, Loïc, Christian Pagnoux, Alexandre Karras, Chahera Khouatra, Olivier Aumaître, Pascal Cohen, François Maurier, et al.. 2014. “Rituximab Versus Azathioprine for Maintenance in Anca-associated Vasculitis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1404231.

New England Journal of MedicineJournal

Rituximab Versus Azathioprine for Maintenance in Anca-associated Vasculitis

clinicaltrials.govStudy

Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis

2019. "Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03906227.