Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Efgartigimod PH20 SC.
- Who it may be relevant to
- Registry conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological Efgartigimod PH20 SC
Efgartigimod treatment per country-specific label for the treatment of CIDP
Primary outcome measures
- Change in aINCAT score over time [Time frame: Up to 2 years and 3 months]
- Change in I-RODS score over time [Time frame: Up to 2 years and 3 months]
- Change in grip strength over time [Time frame: Up to 2 years and 3 months]
- Change in EQ-5D value from index date over time [Time frame: Up to 2 years and 3 months]
Eligibility criteria
Inclusion criteria
- Aged ≥18 years at time of providing informed consent
- Diagnosed with CIDP
- Planned to be receiving efgartigimod treatment within the CIDP treatment label of efgartigimod in the participant's respective country
- Efgartigimod treatment-naïve at time of screening
Exclusion criteria
- Polyradiculoneuropathy due to any other cause(s)
- Current participation in any interventional clinical study at time of screening, or planned participation before initiation of efgartigimod
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 22 centers
- Jüdisches Krankenhaus Berlin — Berlin
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH — Bochum
- UK-RUB - Katholisches Klinikum Bochum - St. Josef Hospital — Bochum
- Universitätsklinikum Köln — Cologne
- Universitätsklinikum Düsseldorf — Düsseldorf
- Universitätsklinikum Frankfurt — Frankfurt
- UKGM - Universitätsklinikum Gießen und Marburg GmbH — Giessen
- Universitätsmedizin Göttingen — Göttingen
- … and 14 more centers
United States · 1 center
- PPD Virtual — Wilmington
Identifiers
NCT: NCT07264426 · ARGX-113-NIS-2501