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Table 2 Features of population included in RCTs

From: Randomized clinical trials in ANCA-associated vasculitis: a systematic analysis of the WHO - International Clinical Trials Registry Platform

PopulationN = 40
 Adults and seniors (adults > 65 years)33 (82.5)
 Adults (18 to 65 years)2 (5)
 All ages4 (10)
 Children1 (2.5)
 GPA + MPA (± renal limited AAV)20 (50)
 only GPA6 (15)
 GPA + MPA + EGPA (± renal limited AAV)5 (12.5)
 only EGPA3 (7.5)
 only MPA2 (5)
 AAV with other vasculitides/autoimmune diseases4 (10)
Diagnosis status
 Newly diagnosed and/or prevalent patients31 (77.5)
 Prevalent patients6 (15)
 Newly diagnosed patients3 (7.5)
Classification criteria used to include patients
 Chapel-Ill nomenclature6 (15)
 Revised Chapel-Ill nomenclature3 (7.5)
 ACR criteria5 (12.5)
 Chapel-Hill nomenclature and/or ACR criteria ± other3 (7.5)
 Clinical diagnosis or not specified19 (47.5)
 Other4 (10)
Main treatment indication
 Induction of remission16 (40)
 Maintenance of remission13 (32.5)
 Induction and maintenance of remission4 (10)
 Other7 (17.5)
Classification of important outcomes
 Patients important outcomes (PIO)37/43* (85)
 Surrogate outcomes (SO)6/43*
 No. of studies with at least one PIO as primary outcome33 (82.5)
Glucocorticoids dose/use included in primary outcome11/43* (25%)
 Glucocorticoids dose/use as the only primary outcome2/43*
  1. If not otherwise specified, data are expressed as number (percentages). *Multiple answers were possible, GPA Granulomatosis with polyangiitis, MPA Microscopic polyangiitis, EGPA Eosinophilic granulomatosis with polyangiitis, AAV ANCA-associated vasculitis, PO primary outcome. * Forty-three primary outcomes for the 40 studies retrieved