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

NCT02414490 | Completed

• 1 other identifier: AHS1-13-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

CIDP

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (5)

• Percentage of IVIg treatment cycles in which the maximum and minimum grip strength (GS) measurements differ by more than 10% of the maximum

  6 months

• Rasch-built Overall Disability Scale

  6 months

• Timed Up and Go test

  6 months

• Overall Neuropathy Limitations Scale

  6 months

• Health-Related Quality of Life (HRQOL)

  6 months

Interventions

Intravenous Immunoglobulin DRUG

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

Also known as: IVIg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• BriovaRx Infusion Services: collaborator
• CSL Behring: collaborator

Study Sites (7)

Neurology at John's Creek

Johns Creek, Georgia, 30097, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Dartmouth-Hitchcock Medical Center/Dartmouth Geisel School of Medicine

Lebanon, New Hampshire, 03756, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 33593867 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood taken for future use will be obtained with each serum IgG sample.

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jeffrey A Allen, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: April 10, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

US (7)