Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Po… (NCT04777734) | Clinical Trial Compass
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Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Plain-language summary
The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options. The program will continue until the patient discontinues treatment or until the reimbursement process for CIDP concludes, whichever comes first.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Cannot be included in an ongoing clinical study and cannot be satisfactorily treated with a product that has regulatory approval
* Is ≥18 years of age at the time of signing the informed consent form
* Patient has a diagnosis of CIDP according to the 2021 EAN/PNS CIDP guidelines
* Patient has progressive or relapsing active disease after prior treatment with corticosteroids or immunoglobulins
Exclusion Criteria:
* Known autoimmune disease or any medical condition that, in the opinion of the treating physician, would interfere with an accurate assessment of clinical symptoms of CIDP or that puts the patient at undue risk
* Is currently being treated or plans to start treatment with monoclonal antibodies or treatments that contain the human Fc domain of the IgG subclass
* Pregnant or lactating state or intention to become pregnant during the program