Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP) (ORBIT-CIDP)
Study on Treatment Outcomes in a Chronic Nerve Condition
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.
This study investigates chronic inflammatory demyelinating polyneuropathy (CIDP), a condition where the body's immune system attacks the myelin sheath of the nerves, leading to weakness and sensory loss. The purpose of this observational study is to collect data on patients with CIDP who have residual impairments despite receiving standard care treatments for at least three months.
Participants will undergo routine medical evaluations and their treatment outcomes will be monitored over time. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
- Who can participate: Adults 18 years or older with a neurologist-confirmed diagnosis of CIDP who have been on specific CIDP treatments for at least three months can participate. They must have residual impairments and cannot be part of another investigational drug trial.
- Study details: Participants will continue their current CIDP treatments while their health outcomes are monitored. No changes to their existing treatment regimen will be made as part of this study.
- Study timelines: The study will last two years.
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