Period | Baseline | Follow-up (until study end or premature discontinuation)* |
---|---|---|
Timing | Enrollment | Every 6 months |
Informed consent | x | |
CAPS phenotype | x | |
CAPS genotype (NLRP-3 mutation), if available | x | |
Non-CAPS medical history | x | |
Vital signs (height, weight, blood pressure) | x | x |
Ilaris dosing/status | x | x |
Historical and concomitant medications for auto-inflammatory disease* | x | x |
Selected AEs* | x | |
Other serious AEs and non-serious adverse reactions* | x | |
CAPS clinical assessment * | x | x |
CAPS-related clinical testing results, if performed | x | x |
Selected local laboratory testing | x | x |
Sexual development status (paediatric only) | x | x |
Neurocognitive status (paediatric only) | x | x |
Cerebrospinal fluid analysis | x | x |
Vaccination record and outcome | x | x |
Pregnancy status (females of child-bearing potential only) | x | |
Registry disposition | x |