Screening period | Observation period | Observation period | Follow-up period | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(Rituximab administration period) | (Investigational drug administration period) | |||||||||||||||||||
Day | Within 35 days | 1 | 8 | 15 | 22 | 29 | 57 | 85 | 113 | 141 | 169 | 225 | 281 | 337 | 393 | 449 | 505 | Relapse | Investigation drug discontinuation | 36/48 month Clinical trial discontinuation |
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | ||||
Obtaining informed consent | â—‹ | |||||||||||||||||||
Medical examination | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | |
Investigation drug administration | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | ||
Background survey | â—‹ | |||||||||||||||||||
Concomitant drug survey | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | |
Height/weight | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â–³ | â—‹ |
Blood pressure | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â–³ | â—‹ |
Pulse, body temperature | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â–³ | ||||||||||
Pregnancy test | â—‹ | |||||||||||||||||||
HIV, HCV, HBVa | â—‹ | |||||||||||||||||||
Electrocardiogram | â—‹ | â—‹ | â–³ | |||||||||||||||||
Chest X-ray | â—‹ | â—‹ | â–³ | |||||||||||||||||
Relapse evaluation | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | |
Adverse event evaluation | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | |
After treatment | â—‹ | |||||||||||||||||||
Hematological examination | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â–³ | |
Immunoglobulin examination | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â–³ | |||||||||||||
Estimated glomerular filtration rate | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | |||||||||||
Urinalysis | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ |
Peripheral blood B cell count | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â—‹ | â–¡ |