chronic inflammatory demyelinating polyradiculoneuropathy
Conditions
Interventions
CIDP patients treated with efgartigimod:None
Sponsors
The First Affiliated Hospital of Chongqing Medical University.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, male or female. 2. Diagnosis of definite or probable Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS 2021) criteria. 3. An Inflammatory Neuropathy Cause and Treatment (INCAT) score of >= 2 at screening, OR presentation at screening due to clinical deterioration reflected by an increase in INCAT score from 0 to 1. 4. For patients receiving concomitant stable-dose CIDP treatments (e.g., corticosteroids and/or non-steroid immunosuppressant drugs [NSIDs]) prior to screening, the following dosage stability conditions must be met: Corticosteroids: Treatment initiated at least 3 months prior to screening, with no change in dosage within 1 month before screening. NSIDs (e.g., azathioprine, methotrexate, cyclosporine, tacrolimus, mycophenolate mofetil, cyclophosphamide): Treatment initiated at least 6 months prior to screening, with no change in dosage within 3 months before screening. 5. Voluntary choice to receive treatment with Efgartigimod, capability to provide signed informed consent, and willingness to comply with all study protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Presence of other chronic autoimmune diseases that are either active or require corticosteroid therapy for maintenance (e.g., rheumatoid arthritis, scleroderma, ulcerative colitis). 2. Coexistence of other severe medical conditions, including but not limited to active hepatitis, tuberculosis, HIV/AIDS, syphilis, or malignancy. 3. Positive test for anti-node of Ranvier antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who have achieved improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| The average change of INCAT score in patients with improved state;The average time for patients to achieve improvement for the first time.;The average number of times that patients who have reached the improvement state use efgartigimod.;Proportion of patients receiving remedial treatment;Proportion of patients with adverse events;According to different baseline INCAT scores, the above indicators were analyzed in subgroups.; | — |
Countries
China
Contacts
Public ContactGuo Xiuming
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed