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

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Brief Title

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

Official Title

Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)

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 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.
    


Study Type

Observational


Primary Outcome

Daily grip strength (GS) measurements

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

Condition

Chronic Inflammatory Demyelinating Polyneuropathy

Intervention

Intravenous Immunoglobulin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

March 2015

Completion Date

May 2020

Primary Completion Date

May 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Definite or probable CIDP according to the European Federation of Neurological Studies
             (ENFS)/Peripheral Nerve Society (PNS) criteria 2010

          2. Inflammatory Neuropathy Cause and Treatment Group (INCAT) upper limb disability score
             of 2 or greater at any time during disease

          3. CIDP Disease Activity Status (CDAS) classification of Stable Active Disease or
             Improvement at time of screening

          4. Men or women age 18-85 years

          5. Receiving physician prescribed intravenous immunoglobulin (IVIg) therapy with a
             treatment interval between a minimum of 21 days and a maximum of 42 days

          6. Be on a stable dose of IVIg for at least 3 months prior to study participation

          7. With proper training from a healthcare professional, demonstrate proficiency in the
             ability to perform daily Jamar Dynamometer grip strength measurements

          8. Ability to have an adult present (e.g., spouse, adult child) to assist with daily
             Dynamometer grip strength measurement, if needed

          9. Eligible for infusion services by AxelaCare Health Solutions, LLC, in collaboration
             with the subject's prescribing physician and insurance provider

         10. Ability to read and write English

         11. Ability and willingness to provide informed consent and comply with study requirements
             and procedures

         12. Confirmation of diagnosis of CIDP by outside expert panel

        Exclusion Criteria:

          1. Any polyneuropathy of other causes, including multifocal motor neuropathy, hereditary
             demyelinating neuropathy, POEMS syndrome, polyneuropathy associated with diabetes
             mellitus, polyneuropathy associated with systemic lupus erythematosus

          2. Subjects who, by majority vote of the outside expert panel do not meet diagnostic
             criteria for CIDP or probably CIDP

          3. CDAS classification of Cure, Remission, or Unstable Active Disease

          4. The presence of any type of recent arm and/or hand bone fracture

          5. The presence of any medical condition that the investigator and/or prescribing
             physician deems incompatible with participation in this trial

          6. Receiving subcutaneous immunoglobulin (SCIg) therapy during study participation

          7. Receiving pulse dose corticosteroids during study participation (daily corticosteroids
             are allowed provided dose equal or less than prednisone 20 mg daily and no anticipated
             dose changes during the study)

          8. Prisoners

          9. Ward of the state
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Jeffrey A Allen, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02414490

Organization ID

AHS1-13-001


Responsible Party

Sponsor

Study Sponsor

University of Minnesota

Collaborators

 BriovaRx Infusion Services

Study Sponsor

Jeffrey A Allen, MD, Principal Investigator, University of Minnesota


Verification Date

August 2020