Table 1 Characteristics of RCTs in AAV patients from WHO International Clinical Trials Registry Platform (ICTRP)
Item and subcategory | RCTs |
|---|---|
N = 40 | |
Single-country studies | 29 (72.5) |
Location of studies (continent)a | |
Europe | 22 (38.5) |
North America | 15 (26.5) |
Asia | 12 (21) |
South America | 2 (3) |
Oceania | 4 (7) |
Africa | 1 (2) |
Unclear | 1 (2) |
Type of intervention | |
Pharmacological therapy | 38 (95) |
Non-biological | 22 (55) |
Biological | 16 (40) |
Study design | |
Parallel group | 38 (95) |
Crossover | 2 (5) |
Type of comparator | |
Active (pharmacologic) | 22 (55) |
Placebo | 14 (35) |
Usual care | 3 (7.5) |
No intervention | 1 (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 applicable | 3 (7.5) |
Status of recruitment | |
Closed recruitment (completed recruitment or terminated studies) | 14 (35) |
Recruiting/ongoing | 14 (35) |
Not yet recruiting | 7 (17.5) |
Withdrawn | 3 (7.5) |
Unknown | 2 (5) |
Industry-funded | 14 (35) |
Sample size | |
No. of patients planned to be included per study | 68 (36–138) |
(median, IQR) | range 14–704 |