IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements
Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Inflammatory Demyelinating Polyneuropathy
Intervention: Intravenous Immunoglobulin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Minnesota - Clinical and Translational Science Institute Official(s) and/or principal investigator(s): Jeffrey A Allen, MD, Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute
Overall contact: Timothy Walton, MHS, CCRP, Phone: 877-342-9352, Ext: 2413, Email: research@axelacare.com
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.
Clinical Details
Official title: Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)
Study design: Observational Model: Cohort, Time Perspective: Prospective
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 maximumRasch-built Overall Disability Scale Timed Up and Go test Overall Neuropathy Limitations Scale Health-Related Quality of Life (HRQOL)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Timothy Walton, MHS, CCRP, Phone: 877-342-9352, Ext: 2413, Email: research@axelacare.com
Neurology at John's Creek, Johns Creek, Georgia 30097, United States; Recruiting Albert Cook, MD, Phone: 678-474-0151 Albert Cook, MD, Principal Investigator
University of Kansas Medical Center, Kansas City, Kansas 66103, United States; Recruiting Laura Herbelin, Phone: 913-588-5095, Email: lherbelin@kumc.edu Mamatha Pasnoor, MD, Principal Investigator
University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting Sarah J Hilbert, MS, CCRP, Phone: 612-624-7745, Email: cnru@umn.edu
University of Virginia, Charlottesville, Virginia 22903, United States; Recruiting Amruta Joshi, MS, Phone: 434-982-0293, Email: asj6n@hscmail.mcc.virginia.edu Ted Burns, MD, Principal Investigator
Additional Information
Starting date: March 2015
Last updated: July 27, 2015
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