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The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the "treatment journey" of participants with CIDP, and assess the utilization of health care services among adult participants with CIDP who initiate treatment with efgartigimod.
As this is a noninterventional study, treatment choices and decisions will be left to the discretion of participants and their physicians, according to the standard of care.
Each participant will be prospectively followed for up to 2 years from the date of initial administration of efgartigimod.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efgartigimod PH20 SC | Biological | Efgartigimod treatment per country-specific label for the treatment of CIDP |
| Measure | Description | Time Frame |
|---|---|---|
| Change in aINCAT score over time | The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome). | Up to 2 years and 3 months |
| Change in I-RODS score over time | Inflammatory Rasch-built Overall Disability Scale (I-RODS) assesses the limitations of activities and social participation in patients with inflammatory neuropathies like CIDP. | Up to 2 years and 3 months |
| Change in grip strength over time | Up to 2 years and 3 months | |
| Change in EQ-5D value from index date over time | The EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome) | Up to 2 years and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult CIDP participants considered to be initiating efgartigimod treatment per country-specific label for the treatment of CIDP
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Coppieters, MD | Contact | 857-350-4834 | clinicaltrials@argenx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Virtual | Recruiting | Wilmington | North Carolina | 28401 | United States |
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| Label | URL |
|---|---|
| Study website | View source |
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| Jüdisches Krankenhaus Berlin | Recruiting | Berlin | 13347 | Germany |
|
| Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH | Recruiting | Bochum | 44789 | Germany |
|
| UK-RUB - Katholisches Klinikum Bochum - St. Josef Hospital | Recruiting | Bochum | 44791 | Germany |
|
| Universitätsklinikum Köln | Recruiting | Cologne | 50937 | Germany |
|
| Universitätsklinikum Düsseldorf | Recruiting | Düsseldorf | 40225 | Germany |
|
| Universitätsklinikum Frankfurt | Recruiting | Frankfurt | 60590 | Germany |
|
| UKGM - Universitätsklinikum Gießen und Marburg GmbH | Recruiting | Giessen | 35392 | Germany |
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| Universitätsmedizin Göttingen | Recruiting | Göttingen | 37075 | Germany |
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| Universitätsklinikum Hamburg Eppendorf | Recruiting | Hamburg | 20251 | Germany |
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| Neurologie Neuer Wall - Dr.Bredow & Partner | Recruiting | Hamburg | 20354 | Germany |
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| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
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| Universitatsklinikum des Saarlandes | Recruiting | Homburg | 66424 | Germany |
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| Universitätsklinikum Magdeburg A.ö.R. | Recruiting | Magdeburg | 39120 | Germany |
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| Universitätsklinikum Mannheim | Recruiting | Mannheim | 68167 | Germany |
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| Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg | Recruiting | Marburg | 35043 | Germany |
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| Mühlenkreiskliniken - Johannes Wesling Klinikum Minden | Recruiting | Minden | 32429 | Germany |
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| Friedrich-Baur-Institute München | Recruiting | München | 80336 | Germany |
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| Alexianer St. Josef Potsdam GmbH | Recruiting | Potsdam | 14471 | Germany |
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| Immanuel Klinik Rüdersdorf | Recruiting | Rüdersdorf | 15562 | Germany |
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| Diakonie-Klinikum Schwäbisch Hall gGmbH | Recruiting | Schwäbisch Hall | 74523 | Germany |
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| Universitätsklinikum Tübingen | Recruiting | Tübingen | 72076 | Germany |
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| Universitätsklinikum Ulm | Recruiting | Ulm | 89081 | Germany |
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| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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