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NCT06968975Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 24 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
4 Apr 2025
Start date
11 Apr 2025
Primary completion date
17 May 2027
Lead sponsor
Sanofi
NCT number
NCT06968975

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 11 Apr 2025 to the primary completion date, 17 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Evidence of participation in any interventional clinical trial with an investigational drug at the time of enrollment

Age

  • 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.

Other

  • Participants are excluded from the study if any of the following criteria apply:
  • Hyperreflexia (increased reflexes) recorded in the medical record during a neurological exam the year before enrollment and after CIDP diagnosis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Investigational Site
Coordinator of this site? Confirm its status
SwiftwaterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.