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Recruiting NCT06968975

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

— Observational Polyneuropathy, Inflammatory Demyelinating, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Primary outcome measures

  • I-RODS score at baseline [Time frame: Baseline]
  • Variations of I-RODS score over the study duration [Time frame: From Baseline up to End of Study (2 years)]
  • Variations of I-RODS score after treatment change [Time frame: From baseline up to End of Study (approx. 2 years)]
  • Annualized I-RODS response rate [Time frame: Up to End of Study (approx. 2 years)]
  • Annualized I-RODS relapse rate [Time frame: Up to End of Study (approx. 2 years)]
Secondary outcome measures (8)
  • Adjusted INCAT (aINCAT) score at baseline and its variations over the study duration and after treatment change [Time frame: Baseline and throughout the study (up to 2 years)]
  • Annualized aINCAT response rate [Time frame: Up to End of Study (approx. 2 years)]
  • Annualized aINCAT relapse rate [Time frame: Up to End of Study (approx. 2 years)]
  • Interobserver variability of remote INCAT assessment [Time frame: Up to End of Study (approx. 2 years)]
  • Incidence of select comorbidities at baseline and over the study duration [Time frame: From Baseline up to End of Study (approx. 2 years)]
  • Frequency of select comorbidities at baseline and over the study duration [Time frame: From Baseline up to End of Study (approx. 2 years)]
  • Laboratory measurements at baseline and over study duration [Time frame: From Baseline up to End of Study (approx. 2 years)]
  • CAP-PRI score at baseline and its variations over the study duration and after treatment change [Time frame: From Baseline to End of Study (approx 2 years)]

Eligibility criteria

Inclusion criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

  • 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

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

  • 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

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Investigational Site — Swiftwater

Identifiers

NCT: NCT06968975 · OBS18653

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗