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

Description

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.

Study Start Date

March 2015

Estimated Completion Date

May 2016

Interventions

  • Drug: Intravenous Immunoglobulin

Specialties

  • Neurology: Neuropathy/Myopathy
  • Physician Assistant: Neurology

MeSH Terms

  • Demyelinating
  • Intravenous Immunoglobulin
  • Polyneuropathies

Study ID

University of Minnesota - Clinical and Translational Science Institute -- AHS1-13-001

Status

Unknown

Trial ID

NCT02414490

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

30

Sponsor

University of Minnesota - Clinical and Translational Science Institute

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

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Columbia University Medical Center - New York, New York 44.8 miles Allan Paras 212-305-6035 ap3476@cumc.columbia.edu
University of Virginia - Charlottesville, Virginia 357.1 miles Amruta Joshi MS 434-982-0293 asj6n@hscmail.mcc.virginia.edu
Northwestern University - Chicago, Illinois 745.5 miles Bart Jacher 312-695-8636 bartosz.jacher@northwestern.edu
Neurology at Johns Creek - Johns Creek, Georgia 776.8 miles Albert Cook MD 678-474-0151 None
University of Minnesota - Minneapolis, Minnesota 1,040.9 miles Sarah J Hilbert MS CCRP 612-624-7745 cnru@umn.edu
University of Kansas Medical Center - Kansas City, Kansas 1,139.3 miles Laura Herbelin 913-588-5095 lherbelin@kumc.edu

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