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Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

Description

This study is an observational, ambispective, descriptive, non-interventional study of people with a chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) diagnosis in the United States with residual impairment, disability, or neurological deficits after at least three months of treatment with standard of care therapy. The study is expected to last two years. Enrollment is expected to continue for one year. Depending on when the participant is enrolled, a participant can be followed for between one and two years, through the end of study, approximately two years after the study starts.

Conditions

Polyneuropathy, Inflammatory Demyelinating, Chronic
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Related Conditions:

Polyneuropathy, Inflammatory Demyelinating, Chronic

Study Overview

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Study Details

Study overview

This study is an observational, ambispective, descriptive, non-interventional study of people with a chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) diagnosis in the United States with residual impairment, disability, or neurological deficits after at least three months of treatment with standard of care therapy. The study is expected to last two years. Enrollment is expected to continue for one year. Depending on when the participant is enrolled, a participant can be followed for between one and two years, through the end of study, approximately two years after the study starts.

Observational, Real-world, Digital Biomarker, and Integrated Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)

Condition
Polyneuropathy, Inflammatory Demyelinating, Chronic
Intervention / Treatment

-

Contacts and Locations

Swiftwater

Investigational Site, Swiftwater, Pennsylvania, United States, 18370-0187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Neurologist-confirmed diagnosis of CIDP found in the medical record, with the last neurologist visit prior to enrollment containing no information that suggests this diagnosis was reversed
  • * Active use of at least one of the following CIDP treatments for three months or longer, with no evidence of discontinuation of this therapy as of the last neurologist visit prior to enrollment
  • * immunoglobulin
  • * corticosteroids, with the exception of prednisone (or equivalent) monotherapy at 10mg or less per day
  • * plasma exchange
  • * efgartigimod alfa
  • * azathioprine
  • * mycophenolate mofetil
  • * cyclosporine
  • * rituximab
  • * methotrexate
  • * Signed informed consent
  • * Residual impairment, disability, or neurological deficits at enrollment, as defined by a raw I-RODS score of 44 or below
  • * Evidence of participation in any interventional clinical trial with an investigational drug at the time of enrollment
  • * Hyperreflexia (increased reflexes) recorded in the medical record during a neurological exam the year before enrollment and after CIDP diagnosis
  • * Aged under 18 at the time of enrollment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2027-05-17