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. 2015 Mar 30;10(3):e0120981. doi: 10.1371/journal.pone.0120981

Table 1. Comparison of the design of 2 randomised controlled trials for vasculitis: MYPAN versus MYCYC.

Trial name and study population MYPAN a : PAN b in children (≥4 and ≤ 18 years) MYCYC c : ANCA d associated vasculitis in adults & children (8 children, 132 adults)
Hypothesis MMF e is not inferior (<10% absolute difference) to intravenous CYC f for induction of remission MMF is not inferior (<12% absolute difference) to intravenous CYC for induction of remission
Entry criteria i) Must fulfil classification criteria for PAN; ii) 1or more major PVAS g items and/or 3 or more minor PVAS items; iii) Must be newly diagnosed patients i) Chronic inflammatory disease lasting at least 4 weeks; characteristic histology on biopsy and/or a positive ANCA; ii) 1 or more major BVAS h items and/or 3 or more minor PVAS items; iii) Must be newly diagnosed patients
Primary endpoint Remission within 6 months defined as PVAS 0/63 on 2 consecutive readings at least one month apart on protocol steroid taper Remission within 6 months defined as BVAS 0/63 on 2 consecutive readings at least one month apart on protocol steroid taper

aMYPAN: Mycophenolate mofetil for childhood polyarteritis nodosa;

bPAN: polyarteritis nodosa;

cMYCYC: Mycophenolate mofetil versus cyclophosphamide for ANCA associated vasculitis;

dANCA: anti neutrophil cytoplasmic antibodies;

eMMF: Mycophenolate mofetil;

fCYC: cyclophosphamide;

gPVAS: Paediatric Vasculitis Activity Score;

hBVAS: Birmingham Vasculitis Activity Score.