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

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT02414490

Collaborator

BriovaRx Infusion Services (Industry), CSL Behring (Industry)

Enrollment

Locations

Actual Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyneuropathy	Drug: Intravenous Immunoglobulin

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 Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

May 1, 2020

Outcome Measures

Primary Outcome Measures

Daily grip strength (GS) measurements [6 months]
Extent of treatment related fluctuations to intravenous immunoglobulin (IVIg) in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) using a Jamar Dynamometer to capture daily grip strength (GS) measurements

Secondary Outcome Measures

Percentage of IVIg treatment cycles in which the maximum and minimum grip strength (GS) measurements differ by more than 10% of the maximum [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 [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 [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 [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) [6 months]
Changes in Health-Related Quality of Life (HRQOL) at three time points during the study (baseline, Week 12 and Week 24)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Definite or probable CIDP according to the European Federation of Neurological Studies (ENFS)/Peripheral Nerve Society (PNS) criteria 2010
Inflammatory Neuropathy Cause and Treatment Group (INCAT) upper limb disability score of 2 or greater at any time during disease
CIDP Disease Activity Status (CDAS) classification of Stable Active Disease or Improvement at time of screening
Men or women age 18-85 years
Receiving physician prescribed intravenous immunoglobulin (IVIg) therapy with a treatment interval between a minimum of 21 days and a maximum of 42 days
Be on a stable dose of IVIg for at least 3 months prior to study participation
With proper training from a healthcare professional, demonstrate proficiency in the ability to perform daily Jamar Dynamometer grip strength measurements
Ability to have an adult present (e.g., spouse, adult child) to assist with daily Dynamometer grip strength measurement, if needed
Eligible for infusion services by AxelaCare Health Solutions, LLC, in collaboration with the subject's prescribing physician and insurance provider
Ability to read and write English
Ability and willingness to provide informed consent and comply with study requirements and procedures
Confirmation of diagnosis of CIDP by outside expert panel

Exclusion Criteria:

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
Subjects who, by majority vote of the outside expert panel do not meet diagnostic criteria for CIDP or probably CIDP
CDAS classification of Cure, Remission, or Unstable Active Disease
The presence of any type of recent arm and/or hand bone fracture
The presence of any medical condition that the investigator and/or prescribing physician deems incompatible with participation in this trial
Receiving subcutaneous immunoglobulin (SCIg) therapy during study participation
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)
Prisoners
Ward of the state

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurology at John's Creek	Johns Creek	Georgia	United States	30097
2	Northwestern University	Chicago	Illinois	United States	60611
3	University of Kansas Medical Center	Kansas City	Kansas	United States	66103
4	University of Minnesota	Minneapolis	Minnesota	United States	55455
5	Dartmouth-Hitchcock Medical Center/Dartmouth Geisel School of Medicine	Lebanon	New Hampshire	United States	03756
6	Columbia University Medical Center	New York	New York	United States	10032
7	University of Virginia	Charlottesville	Virginia	United States	22903