IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements
Condition: Chronic Inflammatory Demyelinating Polyneuropathy
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Observational

Summary: 
      This is a prospective observational study of 30 adult CIDP patients who receive home IVIg
      infusion services from AxelaCare Health Solutions, LLC. The decision to treat with IVIg will
      be entirely at the discretion of the patient's treating physician.
    

Detailed description: 
      Subjects will be recruited by individual site investigators. Prior to enrollment each
      potential subject will have their screening data reviewed by a panel of medical experts for
      confirmation of inclusion criteria. Each reviewer will be an independent, board-certified,
      practicing and experienced neurologist with a special interest in CIDP.

      Enrolled subjects who have provided informed consent will be instructed to perform and
      document daily Jamar hand-held Dynamometer grip strength measurements in a paper diary for a
      6 month time frame.

      Weekly nursing visits will capture disability assessments, physical tests, adverse event and
      concomitant medications assessment, and other clinical changes that may affect grip strength
      measurements. Nurses will review each subjects captured grip data from paper diary on an iPad
      during weekly home assessments. Nurses will also administer the HRQOL Short-Form (SF) 36
      questionnaire at the baseline, week 12 and week 24 study visits.

      Serum immunoglobulin G (IgG) levels will be captured by the home study nurse at three time
      points surrounding IVIg infusions and will be classified as either trough, peak, or mid. Each
      subject will have serum Ig collected by blood draw for the first 4 IVIg treatment cycles, for
      a total of 12 blood draws per subject.

      The "trough" serum IgG level will be collected immediately prior to Ig infusion. The "peak"
      serum IgG level will be collected 5 minutes post-Ig infusion. The "mid" serum IgG level will
      be collected two weeks post-Ig infusion.

      There are currently no known biomarkers that can assist with CIDP diagnosis, prognosis, or
      treatment optimization. As part of this study, subjects will be required to have additional
      blood taken and stored for future use. Future use may include the possible discovery of
      specific biomarkers predicting the response to IVIg or other therapies, optimization of IVIg
      dosage based on pharmacodynamics, pathogenesis of CIDP, and more effective CIDP diagnostic
      markers. Blood taken for future use will be obtained with each serum IgG sample. No
      additional blood draws will be required.

      Should IVIg therapy be discontinued during the study, daily grip strength measurements will
      continue to be performed and recorded in the subject diary for up to 30 days or to the end of
      the study, whichever comes first. Weekly nurse visits with collection of the disability
      assessments and serum IgG blood draws will continue for up to 4 home nurse visits or until
      the end of the study, whichever comes first.
    

Intervention name(s): Intravenous Immunoglobulin
Intervention type(s): Drug
Intervention description(s): The decision to treat with IVIg will be entirely at the discretion of the patient's treating physician.
Other intervention name(s): IVIg
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will include men and women between 18-85 years of age currently being treated
        with IVIg. Up to 30 subjects with a definite or probable diagnosis of CIDP as defined by
        the EFNS/PNS criteria and confirmed by outside review will be enrolled.
      
Biospecimen description: 
      Blood taken for future use will be obtained with each serum IgG sample.
    
Keywords: CIDP