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Chronic Inflammatory Demyelinating PolyneuropathyGRIPPERNCT02414490

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

An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by University of Minnesota at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Intravenous Immunoglobulin
Type of treatment
Injection or infusion
How many people
30 participants
Where
7 sitesUnited States
Study dates
Mar 2015to May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Northwestern University

    Chicago, Illinois, 60611

  • Neurology at John's Creek

    Johns Creek, Georgia, 30097

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103

  • Dartmouth-Hitchcock Medical Center/Dartmouth Geisel School of Medicine

    Lebanon, New Hampshire, 03756

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: Intravenous Immunoglobulin (IVIg) Treatment-Related Fluctuations in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients Using Daily Grip Strength Measurements (GRIPPER)

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.

Read the 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.

Being tested
Intravenous Immunoglobulin
Keywords
CIDP
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous ImmunoglobulinDrug

    Also called IVIg

    The decision to treat with IVIg will be entirely at the discretion of the patient's treating physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

Secondary outcomes (5)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. Overall Neuropathy Limitations Scale

    Changes in Overall Neuropathy Limitations Scale in the event a treating physician decides to modify IVIg therapy during study participation.

    Measured: 6 months

  5. 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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2019
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414490
Sponsor's protocol ID
AHS1-13-001
Acronym
GRIPPER
Status last verified
Aug 2020
First submitted
13 Mar 2015
Last updated
13 Aug 2020
Results posted
No

Publications

  • Allen JA, Pasnoor M, Dimachkie MM, Ajroud-Driss S, Brannagan TH, Cook AA, Walton T, Fiecas MB, Kissel JT, Merkies I, Gorson KC, Lewis RA. Quantifying Treatment-Related Fluctuations in CIDP: Results of the GRIPPER Study. Neurology. 2021 Apr 6;96(14):e1876-e1886. doi: 10.1212/WNL.0000000000011703. Epub 2021 Feb 16.

    PubMed 33593867

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by University of Minnesota at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily grip strength (GS) measurements (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02414490, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.

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