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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