Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT02749292
Eligibility 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 ≥ 73 cc/min/1.73m2
4. Age: 18-82 years old
5. Treated with rituximab-induced continuous B cell depletion at regularly scheduled interval with a goal of undetectable B cells for at least 24 months
6. In sustained remission (defined by a modified BVAS-WG=0 AND a prednisone dose of ≤ 7.5 mg) for at least 12 months.
7. Undetectable (\<10mm3) B cells (quantified by CD20+ number) on day 0
8. 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
9. 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 \< 300 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
82 Years
Study:
NCT02749292
Study Brief:
Protocol Section:
NCT02749292