- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414490
IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements (GRIPPER)
Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Georgia
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Johns Creek, Georgia, United States, 30097
- Neurology at John's Creek
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Kansas
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Kansas City, Kansas, United States, 66103
- University of Kansas Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center/Dartmouth Geisel School of Medicine
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily grip strength (GS) measurements
Time Frame: 6 months
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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
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 months
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Rasch-built Overall Disability Scale
Time Frame: 6 months
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Changes in Rasch-built Overall Disability Scale in the event a treating physician decides to modify IVIg therapy during study participation.
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6 months
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Timed Up and Go test
Time Frame: 6 months
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Changes in Timed up and Go test in the event a treating physician decides to modify IVIg therapy during study participation.
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6 months
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Overall Neuropathy Limitations Scale
Time Frame: 6 months
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Changes in Overall Neuropathy Limitations Scale in the event a treating physician decides to modify IVIg therapy during study participation.
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6 months
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Health-Related Quality of Life (HRQOL)
Time Frame: 6 months
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Changes in Health-Related Quality of Life (HRQOL) at three time points during the study (baseline, Week 12 and Week 24)
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeffrey A Allen, MD, University of Minnesota
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Polyradiculoneuropathy
- Polyneuropathies
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Immunoglobulins
- Immunoglobulins, Intravenous
- gamma-Globulins
- Rho(D) Immune Globulin
Other Study ID Numbers
- AHS1-13-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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