Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

NCT ID: NCT07264426

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-11

Study Completion Date

2029-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Efgartigimod PH20 SC

Efgartigimod treatment per country-specific label for the treatment of CIDP

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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argenx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PPD Virtual

Wilmington, North Carolina, United States

Site Status RECRUITING

Jüdisches Krankenhaus Berlin

Berlin, , Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Site Status RECRUITING

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status RECRUITING

Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Neurologie Neuer Wall - Dr.Bredow & Partner

Hamburg, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Universitatsklinikum des Saarlandes

Homburg, , Germany

Site Status RECRUITING

Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, , Germany

Site Status RECRUITING

Universitätsklinikum Mannheim

Mannheim, , Germany

Site Status RECRUITING

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

Marburg, , Germany

Site Status RECRUITING

Mühlenkreiskliniken - Johannes Wesling Klinikum Minden

Minden, , Germany

Site Status RECRUITING

Friedrich-Baur-Institute München

München, , Germany

Site Status RECRUITING

Immanuel Klinik Rüdersdorf

Rüdersdorf, , Germany

Site Status RECRUITING

Diakonie-Klinikum Schwäbisch Hall gGmbH

Schwäbisch Hall, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status RECRUITING

Universitätsklinikum Ulm

Ulm, , Germany

Site Status RECRUITING

Countries

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United States Germany

Central Contacts

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Sabine Coppieters, MD

Role: CONTACT

857-350-4834

Facility Contacts

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Neil Brett, MD

Role: primary

857-350-4834

Juliane Klehmet, MD

Role: primary

857-350-4834

Michael Gliem, MD

Role: primary

857-350-4834

Yavor Yalachkov, MD

Role: primary

857-350-4834

Jana Zschuentzsch, MD

Role: primary

857-350-4834

Mathias Gelderblom, MD

Role: primary

857-350-4834

Karl Christian Knop, MD

Role: primary

857-350-4834

Aiden Haghikia, MD

Role: primary

857-350-4834

Fatma Merzou, MD

Role: primary

857-350-4834

Heike Stephanik, MD

Role: primary

857-350-4834

Hans-Werner Rausch, MD

Role: primary

857-350-4834

Clemens Warnke, MD

Role: primary

857-350-4834

Jörg Philipps, MD

Role: primary

857-350-4834

Stephan Wenninger, MD

Role: primary

857-350-4834

Karsten Kummer, MD

Role: primary

857-350-4834

Benjamin Knier, MD

Role: primary

857-350-4834

Alexander Grimm, MD

Role: primary

857-350-4834

Johannes Dorst, MD

Role: primary

857-350-4834

Other Identifiers

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ARGX-113-NIS-2501

Identifier Type: -

Identifier Source: org_study_id

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