Immunoglobulin Dosage and Administration Form in CIDP and MMN
Condition: Chronic Inflammatory Demyelinating Polyneuropathy; Multifocal Motor Neuropathy; Hemolytic Anemia
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Anemia; Anemia, Hemolytic; Hemolysis
Study type: Observational

Summary: 
      The aim of this study is to evaluate development of hemolysis and the variation in isokinetic
      muscle strength in two groups of patients with chronic inflammatory demyelinating
      polyneuropathy (CIDP) or multifocal motor neuropathy (MMN)

        1. Patients shifted from 3- or 6-weekly treatment with intravenous immunoglobulin (IVIG) to
           weekly treatment with subcutanoeus immunoglobulin (SCIG)

        2. Patients shifted from SCIG treatment with Subcuvia® or Hizentra® to Gammanorm®.

      Hypotheses

        -  During treatment with IVIG blood hemoglobin will fluctuate with a decline due to
           infusion, whereas it will remain stable during SCIG treatment without fluctuation

        -  Isokinetic muscle strength in affected muscle groups is more stable during treatment
           with SCIG than with IVIG

        -  Blood hemoglobin and changes in muscle strength is comparable during Subcuvia® or
           Hizentra® and Gammanorm® treatment
    

Detailed description: 
      Due to planned switch of treatment with immunoglobulin at Department of neurology
      (Rigshospitalet) patients treated with IVIG will be shifted to treatment with SCIG with an
      unaltered dosage. The medication is administered at home two or three times weekly. IVIG is
      often administered every 3 to 6 weeks. All patients will be trained in managing the treatment
      with SCIG by a nurse from the neurological department. When the patient is able to manage the
      treatment regimen it can be done at home.

      All patients will be evaluated eight times during the study period. Four times before and
      four times after shift of treatment.

      Prior to participation the intervals will be standardized to 3 or 6 weeks giving an extra
      infusion for those with an interval of 3 weeks, i.e. patients on 4-week interval will be
      switched to 3-week interval while patients on 5-week interval will be switched to 6-week
      interval. The dose will be adjusted leading to an unchanged weekly dose of IVIG. All patients
      will be evaluated in connection to two IVIG infusions. For those receiving 3 infusions
      examinations will be executed before and 2 weeks after the first and last infusion. SCIG is
      initiated 2 weeks after the last IVIG infusion.

      Patients on maintenance therapy with Subcuvia® or Hizentra® will be shifted to treatment with
      Gammanorm® according to guidelines from the Danish Healthcare Society, the weekly dose of
      immunoglobulin being unaltered. They will be evaluated 3 times (once before, at the time of
      shift of SCIG and once after).

      All evaluations at each time point in both groups consist of measurement of isokinetic muscle
      strength of four affected muscle groups and blood sampling detecting blood hemoglobin and
      hemolytic parameters.
    

Intervention name(s): Immunoglobulins
Intervention type(s): Drug
Intervention description(s): SCIG dosage is individualized for each patient according to previous IVIG dosage
Other intervention name(s): Gammanorm(R), immunoglobulin for subcutaneous use
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with CIDP or MMN in maintenance treatment with immunoglobulins
      
Keywords: Immunoglobulins, Intravenous; Immunoglobulins, Subcutaneous