Real-world efgartigimod use in adults with CIDP
Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
This study will see if efgartigimod helps adults with CIDP when given as part of routine clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | argenx Industry-sponsored |
| Locations | 23 sites (Wilmington, North Carolina and 22 other locations) |
| Trial ID | NCT07264426 on ClinicalTrials.gov |
What this trial studies
This is a prospective, noninterventional study that will follow adults with CIDP who are starting efgartigimod in routine practice for up to two years. Treatment choices and timing are left to participants and their physicians according to local standard of care. The study will document each participant's treatment journey, clinical outcomes, and healthcare service use after initiating efgartigimod. Enrollment is open at selected sites including a U.S. virtual site and German hospital centers, and participants must be efgartigimod‑naïve at baseline.
Who should consider this trial
Good fit: Adults (18 years or older) with a diagnosis of CIDP who have not previously received efgartigimod and plan to start it within the approved label in their country.
Not a fit: People with polyradiculoneuropathy due to other causes, those already treated with efgartigimod, or those enrolled in interventional clinical trials are unlikely to benefit from joining this observational study.
Why it matters
Potential benefit: If positive, the results could show that efgartigimod improves symptoms or reduces healthcare use for adults with CIDP in real-world settings.
How similar studies have performed: Efgartigimod has demonstrated benefit in related autoimmune neuromuscular disease (myasthenia gravis) and some clinical trials in CIDP have shown promise, but large real-world CIDP datasets remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wilmington, North Carolina and 22 other locations
- PPD Virtual — Wilmington, North Carolina, United States (Recruiting)
- Jüdisches Krankenhaus Berlin — Berlin, Germany (Recruiting)
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH — Bochum, Germany (Recruiting)
- UK-RUB - Katholisches Klinikum Bochum - St. Josef Hospital — Bochum, Germany (Recruiting)
- Universitätsklinikum Köln — Cologne, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Frankfurt — Frankfurt, Germany (Recruiting)
- UKGM - Universitätsklinikum Gießen und Marburg GmbH — Giessen, Germany (Recruiting)
- Universitätsmedizin Göttingen — Göttingen, Germany (Recruiting)
- Universitätsklinikum Hamburg Eppendorf — Hamburg, Germany (Recruiting)
- Neurologie Neuer Wall - Dr.Bredow & Partner — Hamburg, Germany (Recruiting)
- Medizinische Hochschule Hannover — Hanover, Germany (Recruiting)
- Universitatsklinikum des Saarlandes — Homburg, Germany (Recruiting)
- Universitätsklinikum Magdeburg A.ö.R. — Magdeburg, Germany (Recruiting)
- Universitätsklinikum Mannheim — Mannheim, Germany (Recruiting)
- Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg — Marburg, Germany (Recruiting)
- Mühlenkreiskliniken - Johannes Wesling Klinikum Minden — Minden, Germany (Recruiting)
- Friedrich-Baur-Institute München — München, Germany (Recruiting)
- Alexianer St. Josef Potsdam GmbH — Potsdam, Germany (Recruiting)
- Immanuel Klinik Rüdersdorf — Rüdersdorf, Germany (Recruiting)
- Diakonie-Klinikum Schwäbisch Hall gGmbH — Schwäbisch Hall, Germany (Recruiting)
- Universitätsklinikum Tübingen — Tübingen, Germany (Recruiting)
- Universitätsklinikum Ulm — Ulm, Germany (Recruiting)
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: clinicaltrials@argenx.com
- Phone: 857-350-4834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.