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

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: AxelaCare Health Solutions, LLC; BriovaRx Infusion Services; CSL Behring
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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