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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02414490
Date of registration: 13/03/2015
Prospective Registration: Yes
Primary sponsor: University of Minnesota
Public title: IVIg Treatment-Related Fluctuations in CIDP Patients Using Daily Grip Strength Measurements GRIPPER
Scientific title: Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)
Date of first enrolment: March 2015
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02414490
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
United States
Contacts
Name:     Jeffrey A Allen, MD
Address: 
Telephone:
Email:
Affiliation:  University of Minnesota
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention(s)
Drug: Intravenous Immunoglobulin
Primary Outcome(s)
Daily grip strength (GS) measurements [Time Frame: 6 months]
Secondary Outcome(s)
Health-Related Quality of Life (HRQOL) [Time Frame: 6 months]
Overall Neuropathy Limitations Scale [Time Frame: 6 months]
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]
Rasch-built Overall Disability Scale [Time Frame: 6 months]
Timed Up and Go test [Time Frame: 6 months]
Secondary ID(s)
AHS1-13-001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
BriovaRx Infusion Services
CSL Behring
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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