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Serologic ANCA flare for Vasculitis (MAINTANCAVAS Trial)

Phase 4

Waitlist Available

Led By John L Niles, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up median follow-up period of 4.1 years (iqr, 2.5 - 5.0)

Awards & highlights

MAINTANCAVAS Trial Summary

This trial will compare the best way to keep people with a certain kind of blood vessel inflammation in remission after treatment.

Eligible Conditions

ANCA-Associated Vasculitis

MAINTANCAVAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ median follow-up period of 4.1 years (iqr, 2.5 - 5.0)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~median follow-up period of 4.1 years (iqr, 2.5 - 5.0)

This trial's timeline: 3 weeks for screening, Varies for treatment, and median follow-up period of 4.1 years (iqr, 2.5 - 5.0) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Patients With Disease Relapse(s) as Defined by a Birmingham Vasculitis Activity Score for Wegner's Granulomatosis (BVAS/WG) ≥ 2

Secondary outcome measures

Composite of Disease Relapse (Defined a BVAS/WG ≥ 2) and Serious Adverse Events

Health-related Quality of Life as Assessed by the Short Form Health Survey (SF-36) Scores

Mean Number of Rituximab Infusions Per Subject

+6 more

MAINTANCAVAS Trial Design

2Treatment groups

Active Control

Group I: Serologic ANCA flareActive Control1 Intervention

Subjects will not receive regularly scheduled every six-month doses of rituximab (1000mg IV) and will instead be seen in clinic for ANCA titer monitoring every 3 months. Re-dosing will occur upon a significant ANCA titer increase. For MPO, a significant rise will be defined as a 5-fold rise in ANCA titer and a level greater than 4 times the cutoff value for the assay. For PR3, a significant rise will be defined as a 4-fold rise in ANCA titer to a level at least twofold above the cutoff for the assay. Subjects who sustain a significant increase in ANCA titer will receive rituximab 1000mg IV x 2 doses, spaced ~2-3 weeks apart. If the ANCA titer remains two-fold above baseline and above a specified threshold (the cutoff value of the assay for PR3 and 4 times the cutoff value for MPO) , subjects will continue to receive rituximab 1000mg IV every 6 months for a maximum of 2 doses, at which time a new baseline ANCA titer will be established and the cycle will re-start.

Group II: B cell reconstitutionActive Control1 Intervention

Subjects will not receive their regularly-scheduled every-six-month dose of rituximab and will instead receive rituximab 1000 mg IV x 1 dose once peripheral B cells return ( ≥ 10 B cells/mm3). This cycle will then re-start. Subjects will be seen in clinic every three months. Patients will continue to be dosed with rituximab each time the B cell count rises to 10 cells/mm3. In the unique scenario that the B cells are detectable, but less than the threshold of 10 cells/mm3, subjects will be asked to return in 6 weeks for repeat B cell testing.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,240 Total Patients Enrolled

2 Trials studying Vasculitis

70 Patients Enrolled for Vasculitis

John L Niles, MD4.34 ReviewsPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital

5Patient Review

Dr Nile is an expert in ANCA Vasculitis and nephrology. He is kind, attentive, and always has a plan. His team is also large and well-coordinated. Plus, the in-house lab ensures fast results. Overall, I feel very attended to by Dr Nile and his staff.

Frequently Asked Questions

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

Could people who are younger than 45 years old qualify for this clinical research?

"The age limit for this clinical trial is 82 years old. All participants must be 18 years or older."

Answered by AI

Are there any dangers associated with Serologic ANCA flare?

"Serologic ANCA flare has already been approved, meaning it is a safe treatment with a score of 3."

Answered by AI

How many people are receiving care in this research project?

"Yes, the clinical trial is still enrolling patients according to the information available on clinicaltrials.gov. This particular trial was posted on 6/1/2016 and was last updated on 7/28/2021. They are looking for 200 more participants across 1 site."

Answered by AI

Are there still opportunities to join this research project?

"The information available on clinicaltrials.gov reveals that this study is actively seeking patients. This trial was first posted on June 1st, 2016 and was last updated on July 28th, 2021. The research team is hoping to find 200 individuals willing to take part in the study at 1 location."

Answered by AI