Protocol Synopsis V1.1 - Rare Disease

EudraCT number: 2012-001102-14 Page 9 of 42EQ5D2. Health-related quality of life andpatient-reported domains as measuredusing PROMIS3. Serum rituximab levels, andcorrelation with circulating B cellcounts including key subsets andimmunoglobulin levels4. Changes in ANCA titres (both anti-MPOand anti-PR3 subsets) in relation totreatment, response, and relapse.5. HACA rate and levels6. Serum will be stored for futurebiomarker studies7. mRNA will stored for disease andinflammatory gene activation studies8. DNA will be stored for future geneticstudiesSample SizeSummary of Eligibility CriteriaEnrolment will be ongoing until 160 patientsare randomised. It is anticipated this willrequire 190 patients to be recruited.Subjects must meet all of the followingcriteria to be eligible for enrolment:1. Written informed consent (15 yearsand above)2. A diagnosis of AAV (granulomatosiswith polyangiitis (Wegener's) ormicroscopic polyangiitis), according tothe definitions of the Chapel HillConsensus Conference3. Current or historical PR3/MPO ANCApositivity by ELISA4. Disease relapse defined by one majoror three minor disease activity itemson the Birmingham Vasculitis ActivityScore for Wegener’s (BVAS/WG), inpatients that have previously achievedremission following induction therapyKey Exclusion CriteriaInvestigational MedicinalProduct and Dosage1. Age < 15 years (age < 18 years atcentres that do not treat paediatricpatients)2. Previous therapy with any biological B celldepleting agent (such as rituximab orbelimumab) within the past 6 monthsRituximabInduction RegimenPatients will be recruited at the time ofrelapse. All will receive rituximab375 mg/m 2 /week x 4 doses andRITAZAREM Version Number: 2.0 Date: 3 rd October 2013