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Table 1 Definition of reference visit and last visit of study periods

From: Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial

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 1 day 1 at start of IVIg infusion

Week 1 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

  1. IgG immunoglobulin G, INCAT Inflammatory Neuropathy Cause and Treatment, IVIg intravenous immunoglobulin, I-RODS inflammatory-Rasch-built overall disability scale, SC subcutaneous
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Trials

ISSN: 1745-6215