Table 2 Data acquisition plan for TRUST
Documented items | Baseline (visit #1) | Approximately every 3 months (visits #2–13) until month 36 |
|---|---|---|
Definition of investigator’s infrastructure | x | |
Informed consent | x | |
Patient demographic characteristics | x | |
History (medical, MS): | x | |
First MS diagnosis | ||
Other underlying diseases | ||
History of EDSS score | ||
History of relapses | ||
History of (previous) MS therapy | ||
MRI status at baseline | ||
Opportunistic infections before start of natalizumab treatment | ||
History of natalizumab treatment | x | |
Status of current treatment | x | |
Current EDSS score | x | x |
Relapse(s) since last visit (number, date) | x | |
AE at/since (last) visit (yes, no) | x | continuously |
Anti-JCV serostatus | x | |
Other biomarkers collected or evaluated (e.g. anti-JCV antibody index) | x | |
Resources used (nurse contact, other HCP, clinic) | x | |
Lymphocytes and other critical laboratory parameters in association with natalizumab treatment | x | x |
Opportunistic infections | x | |
TSQM-9 (treatment satisfaction) | x | every 12 months |
FSMC (fatigue) | x | every 12 months |
MSIS-29 (MS-related quality of life) | x | every 12 months |
HADS (depression) | x | every 6 months |
SDMT (cognitive function) | x | every 6 months |
WPAI (productivity) | x | every 6 months |
Expert advice requested | if available | |
MRI results | x | if available |