Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP)
Study of Real-World Outcomes in Adults With CIDP After Standard Treatment
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic
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Age: 18 years or above
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Gender: All
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.
The purpose of this research study is to describe treatment outcomes in adults in the United States who have chronic inflammatory demyelinating polyneuropathy/polyradiculoneuropathy (CIDP) and who still have ongoing problems (such as disability or nerve-related symptoms) after at least three months of standard CIDP treatment.
Participants will not receive a study treatment as part of this study. The study team will collect information from participants’ medical records about their CIDP and the treatments they are using.
Who can participate:
Adults with CIDP may be able to participate if they:
- Are 18 years or older
- Have a neurologist-confirmed CIDP diagnosis in their medical record
- Are currently using at least one standard CIDP treatment and have been using it for three months or longer
- Still have disability or nerve-related problems at the time they join the study
Study timeline and visits:
Participation lasts between 1 and 2 years, depending on when a person joins the study. The study is expected to last about 2 years in total.
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