Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the best management strategy to maintain remission in patients with ANCA vasculitis who have been treated with rituximab induced B cell depletion for at least two years. This study will compare intermittent B Cell depletion upon B cell return or intermittent B cell depletion upon serologic relapse.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Rituximab

Criteria

Inclusion Criteria:

1. All patients must be able and willing to give written informed consent and comply with the requirements of the study protocol.

2. Diagnosis: ANCA vasculitis as defined by a positive MPO- and/or PR3-ANCA test together with clinical features characteristic of ANCA-positive diseases as detailed in the 2012 Chapel Hill Consensus Conference Definitions(18).

3. eGFR ≥ 30 cc/min/1.73m2

4. Age: 18-82 years old

5. Treated with rituximab-induced continuous B cell depletion and in remission (defined by a modified BVAS-WG=0 AND a prednisone dose of ≤ 7.5 mg) for at least 24 months.

6. CD20 (B cells) undetectable at time of enrollment/randomization

7. Urine Hcg negative for women of child bearing potential and not planning to become pregnant for at least 12 months from enrollment and at least 12 months after any study related rituximab dose

8. Judged to be otherwise healthy by the Investigator, based on medical history and physical examination (no known active disease process for which life expectancy is less than 36 months)

Exclusion Criteria:

1. Secondary Disease: disease suspected to be induced by levamisole-adulterated cocaine

2. All transplanted patients

3. Treatment: additional immunosuppressive agents other than rituximab and/or total daily prednisone dose ≥ 7.5 milligrams

4. Hypogammaglobulinemia: IgG level < 250 mg/dL

5. Terminal cancer or other primary illness with life expectancy of less than 36 months

6. Active anti-GBM disease and other known autoimmune disease for which the need for additional immunosuppression is likely

7. Pregnancy or breastfeeding