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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02414490
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : August 13, 2020
Sponsor:
Collaborators:
BriovaRx Infusion Services
CSL Behring
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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
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
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Study Type : Observational
Estimated 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 : March 2015
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

Groups and Cohorts
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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

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414490


Locations
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United States, Georgia
Neurology at John's Creek
Johns Creek, Georgia, United States, 30097
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Hampshire
Dartmouth-Hitchcock Medical Center/Dartmouth Geisel School of Medicine
Lebanon, New Hampshire, United States, 03756
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Minnesota
BriovaRx Infusion Services
CSL Behring
Investigators
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Principal Investigator: Jeffrey A Allen, MD University of Minnesota
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02414490    
Other Study ID Numbers: AHS1-13-001
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Keywords provided by University of Minnesota:
CIDP
Additional relevant MeSH terms:
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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
 Chronic Disease
Disease Attributes
Pathologic Processes
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs