Exploring durable remission with rituximab in ANCA associated vasculitis
- Conditions
- ANCA-associated vasculitis
- Registration Number
- NL-OMON21172
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 47
4.1. Inclusion criteria
Subjects enrolled in the study must meet the following inclusion criteria:
1) Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic Polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions26
2) Aged at least 18 years, with newly-diagnosed or relapsed AAV with ‘generalised disease’, defined as involvement of at least one major organ (e.g. kidney, lung, heart, peripheral or central nervous system), requiring induction treatment with cyclophosphamide or rituximab
3) Positive test for anti-PR3 or anti-MPO (current or historic)
4) Willing and able to give written Informed Consent and to comply with the requirements of
the study protocol
4.2. Exclusion criteria
Subjects will be excluded from participation if they meet any of the following exclusion criteria:
1) Pregnant or breast-feeding
2) Active pregnancy, as proven by a positive urine beta-HCG test or a positive serum beta-HCG
3) Significant hypogammaglobulinemia (IgG < 4.0 g/L) or an IgA deficiency (IgA < 0.1 g/L)
5) Active infection at time of screening, as follows:
-Hospitalization for treatment of infection within previous 60 days of day 0 of the study
-Use of parenteral (intravenous of intramuscular) antibiotics (including anti-bacterials, anti-virals, anti-fungals or anti-parasitic agents) within previous 60 days of day 0 of the study
-Serological evidence of viral hepatitis defined as: patients positive for HbsAg
test or HBcAb or a positive hepatitis C antibody not treated with antiviral medication
-Have a historically positive HIV test or test positive at screening for HIV
6) Have a history of a primary immunodeficiency
7) Have a significant infection history that in the opinion of the investigator would make the candidate unsuitable for the study
8) Have a neutrophil count of < 1.5x10E9/L
9) Evidence of hepatic disease: AST, ALT, alkaline phosphatase, or bilirubin > 3 times the upper limit of normal before start of dosing
11) Have any other clinically significant abnormal laboratory value in the opinion of the investigator
12) Required dialysis or plasma exchange within 12 weeks prior to screening
13) Received intravenous glucocorticoids, >3000mg methylprednisolone equivalent, within 4 weeks prior to screening
14) Immunization with a live vaccine 1 month before screening
15) History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the patient at unacceptable risk for study participation.
16) Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method