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Table 1 Characteristics of RCTs in AAV patients from WHO International Clinical Trials Registry Platform (ICTRP)

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

Item and subcategoryRCTs
N = 40
Single-country studies29 (72.5)
Location of studies (continent)a
 Europe22 (38.5)
 North America15 (26.5)
 Asia12 (21)
 South America2 (3)
 Oceania4 (7)
 Africa1 (2)
 Unclear1 (2)
Type of intervention
Pharmacological therapy38 (95)
  Non-biological22 (55)
  Biological16 (40)
Study design
 Parallel group38 (95)
 Crossover2 (5)
Type of comparator
 Active (pharmacologic)22 (55)
 Placebo14 (35)
 Usual care3 (7.5)
 No intervention1 (2.5)
Phase of development
 Early development (phase 0, I)0 (0)
 Middle development (phase I/II, II)10 (25)
 Late development (phase II/III,III, IV)27 (67.5)
 Not reported/not applicable3 (7.5)
Status of recruitment
 Closed recruitment (completed recruitment or terminated studies)14 (35)
 Recruiting/ongoing14 (35)
 Not yet recruiting7 (17.5)
 Withdrawn3 (7.5)
 Unknown2 (5)
Industry-funded14 (35)
Sample size
 No. of patients planned to be included per study68 (36–138)
  (median, IQR)range 14–704
  1. aMultiple answers were possible. RCTs randomized controlled trials