Status:
RECRUITING
Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
Lead Sponsor:
Sanofi
Conditions:
Polyneuropathy, Inflammatory Demyelinating, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This study is an observational, ambispective, descriptive, non-interventional study of people with a chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) diagnosis in the Un...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 17 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06968975
Start Date
April 11 2025
End Date
May 17 2027
Last Update
June 29 2025
Active Locations (1)
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1
Investigational Site
Swiftwater, Pennsylvania, United States, 18370-0187