Test | Study visit | |||||||
---|---|---|---|---|---|---|---|---|
1 (Baseline) | 2 (4–6 weeks) | 3 (12th week) | 4 (14–16 weeks) | 5 (24 weeks) | 7 (28–32 weeks) | 8 (36th week) | End of study (48th week) | |
Demographics | X | X | X | X | X | |||
Medical history | X | X | X | X | X | |||
Clinical assessment | X | X | X | X | X | |||
SLEDAI assessment | X | X | X | X | X | |||
Renal Function assessment | X | X | X | X | X | |||
Immunological Study | X | X | X | X | X | |||
Adverse event assessment | X | X | X | X | X | X | X | |
Pharmacokinetic analysis— total 3 sampling occasions | ☼ | ☼ | ☼ |