Clinical Trial: IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurement

Brief 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 Summary:

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
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Daily grip strength (GS) measurements [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Percentage of IVIg treatment cycles in which the maximum and minimum grip strength (GS) measurements differ by more than 10% of the maximum [ Time Frame: 6 months ]
  Determine the percentage of IVIg treatment cycles in which the maximum and minimum grip strength (GS) measurements differ by more than 10% of the maximum and determine the percentage of subjects who have fluctuations of that magnitude.
• Rasch-built Overall Disability Scale [ Time Frame: 6 months ]
  Changes in Rasch-built Overall Disability Scale in the event a treating physician decides to modify IVIg therapy during study participation.
• Timed Up and Go test [ Time Frame: 6 months ]
  Changes in Timed up and Go test in the event a treating physician decides to modify IVIg therapy during study participation.
• Overall Neuropathy Limitations Scale [ Time Frame: 6 months ]
  Changes in Overall Neuropathy Limitations Scale in the event a treating physician decides to modify IVIg therapy during study participation.
• Health-Related Quality of Life (HRQOL) [ Time Frame: 6 months ]
  Changes in Health-Related Quality of Life (HRQOL) at three time points during the study (baseline, Week 12 and Week 24)

Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: March 13, 2015
Date Started: March 2015
Date Completion: May 2017
Last Updated: June 23, 2016
Last Verified: June 2016