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.
- ANCA-Associated Vasculitis
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: from enrollment to end of study, approximately 2.5 to 3 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
3 Treatment Groups
low CD5+ /on maintenance
1 of 3
high CD5/ on maintenance
1 of 3
high CD5 / NO maintenance
1 of 3
Active Control
Experimental Treatment
40 Total Participants · 3 Treatment Groups
Primary Treatment: ENUMERATION OF CD5+ B Cells · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 85 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- 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.
- 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.
- Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaitre O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quemeneur T, Blanchard-Delaunay C, Godmer P, Puechal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L; French Vasculitis Study Group. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014 Nov 6;371(19):1771-80. doi: 10.1056/NEJMoa1404231.
- 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.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor