Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial
— GRIPPEROfficial title:
Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)
NCT number | NCT02414490 |
Other study ID # | AHS1-13-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | May 2020 |
Verified date | August 2020 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2020 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | Neurology at John's Creek | Johns Creek | Georgia |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Dartmouth-Hitchcock Medical Center/Dartmouth Geisel School of Medicine | Lebanon | New Hampshire |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | BriovaRx Infusion Services, CSL Behring |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily grip strength (GS) measurements | 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 | 6 months | |
Secondary | Percentage of IVIg treatment cycles in which the maximum and minimum grip strength (GS) measurements differ by more than 10% of the maximum | 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. | 6 months | |
Secondary | Rasch-built Overall Disability Scale | Changes in Rasch-built Overall Disability Scale in the event a treating physician decides to modify IVIg therapy during study participation. | 6 months | |
Secondary | Timed Up and Go test | Changes in Timed up and Go test in the event a treating physician decides to modify IVIg therapy during study participation. | 6 months | |
Secondary | Overall Neuropathy Limitations Scale | Changes in Overall Neuropathy Limitations Scale in the event a treating physician decides to modify IVIg therapy during study participation. | 6 months | |
Secondary | Health-Related Quality of Life (HRQOL) | Changes in Health-Related Quality of Life (HRQOL) at three time points during the study (baseline, Week 12 and Week 24) | 6 months |
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