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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

Population

N = 40

Age

 Adults and seniors (adults > 65 years)

33 (82.5)

 Adults (18 to 65 years)

2 (5)

 All ages

4 (10)

 Children

1 (2.5)

Disease

 GPA + MPA (± renal limited AAV)

20 (50)

 only GPA

6 (15)

 GPA + MPA + EGPA (± renal limited AAV)

5 (12.5)

 only EGPA

3 (7.5)

 only MPA

2 (5)

 AAV with other vasculitides/autoimmune diseases

4 (10)

Diagnosis status

 Newly diagnosed and/or prevalent patients

31 (77.5)

 Prevalent patients

6 (15)

 Newly diagnosed patients

3 (7.5)

Classification criteria used to include patients

 Chapel-Ill nomenclature

6 (15)

 Revised Chapel-Ill nomenclature

3 (7.5)

 ACR criteria

5 (12.5)

 Chapel-Hill nomenclature and/or ACR criteria ± other

3 (7.5)

 Clinical diagnosis or not specified

19 (47.5)

 Other

4 (10)

Main treatment indication

 Induction of remission

16 (40)

 Maintenance of remission

13 (32.5)

 Induction and maintenance of remission

4 (10)

 Other

7 (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 outcome

33 (82.5)

Glucocorticoids dose/use included in primary outcome

11/43* (25%)

 Glucocorticoids dose/use as the only primary outcome

2/43*

  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