IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements (GRIPPER)
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|ClinicalTrials.gov Identifier: NCT02414490|
Recruitment Status : Active, not recruiting
First Posted : April 10, 2015
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment|
|Chronic Inflammatory Demyelinating Polyneuropathy||Drug: Intravenous Immunoglobulin|
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 :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
- Drug: Intravenous Immunoglobulin
The decision to treat with IVIg will be entirely at the discretion of the patient's treating physician.Other Name: IVIg
- 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
- 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
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
|United States, Georgia|
|Neurology at John's Creek|
|Johns Creek, Georgia, United States, 30097|
|United States, Illinois|
|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|
|Principal Investigator:||Jeffrey A Allen, MD||University of Minnesota - Clinical and Translational Science Institute|