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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
AxelaCare Health Solutions, LLC
CSL Behring
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02414490
First received: March 13, 2015
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
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 Intervention
Chronic Inflammatory Demyelinating Polyneuropathy Drug: Intravenous Immunoglobulin

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Daily grip strength (GS) measurements [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 6 months ]
    Changes in Health-Related Quality of Life (HRQOL) at three time points during the study (baseline, Week 12 and Week 24)


Biospecimen Retention:   Samples With DNA
Blood taken for future use will be obtained with each serum IgG sample.

Estimated Enrollment: 30
Study Start Date: March 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Intravenous Immunoglobulin
    The decision to treat with IVIg will be entirely at the discretion of the patient's treating physician.
    Other Name: IVIg
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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will include men and women between 18-85 years of age currently being treated with IVIg. Up to 30 subjects with a definite or probable diagnosis of CIDP as defined by the EFNS/PNS criteria and confirmed by outside review will be enrolled.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02414490

Contacts
Contact: Timothy Walton, MHS, CCRP 877-342-9352 ext 2413 research@axelacare.com

Locations
United States, Georgia
Neurology at John's Creek Recruiting
Johns Creek, Georgia, United States, 30097
Contact: Albert Cook, MD    678-474-0151      
Principal Investigator: Albert Cook, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Bart Jacher    312-695-8636    bartosz.jacher@northwestern.edu   
Principal Investigator: Senda Ajroud-Driss, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66103
Contact: Laura Herbelin    913-588-5095    lherbelin@kumc.edu   
Principal Investigator: Mamatha Pasnoor, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sarah J Hilbert, MS, CCRP    612-624-7745    cnru@umn.edu   
United States, New Hampshire
Dartmouth-Hitchcock Medical Center/Dartmouth Geisel School of Medicine Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Charlotte A Jeffreys    603-650-3834    NeurologyResearch@hitchcock.org   
Principal Investigator: Victoria H Lawson, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Allan Paras    212-305-6035    ap3476@cumc.columbia.edu   
Principal Investigator: Thomas H Brannagan III, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Amruta Joshi, MS    434-982-0293    asj6n@hscmail.mcc.virginia.edu   
Principal Investigator: Ted Burns, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
AxelaCare Health Solutions, LLC
CSL Behring
Investigators
Principal Investigator: Jeffrey A Allen, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02414490     History of Changes
Other Study ID Numbers: AHS1-13-001
Study First Received: March 13, 2015
Last Updated: June 16, 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
CIDP

Additional relevant MeSH terms:
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 22, 2017