Period | First visit of period | Reference visit(s) of period | Last visit | |
---|---|---|---|---|
IgG dependency | Screening | Prior to AMD3: INCAT. After AMD3: INCAT: day 14 phone call I-RODS / mean grip strength: peak value within first 4 weeks | Week 1 day 1, before start of IVIg infusion | …or last visit before/at withdrawal |
IVIg restabilization | Week 1Â day 1 at start of IVIg infusion | Week 1Â day 1 at start of IVIg infusion. If not available, last visit of IgG Dependency Period | SC week 1 before start of SC infusion | |
SC treatment | SC week 1 at start of SC infusion | Baseline (week 10/13) | Week 25 visit or first IVIg infusion for rescue before IVIg infusion | |
IVIg rescue | first IVIg infusion for rescue at start of IVIg infusion | First IVIg infusion for rescue at start of IVIg infusion | Completion visit |