Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

April 22, 2026 updated by: argenx

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13347
        • Recruiting
        • Jüdisches Krankenhaus Berlin
        • Contact:
      • Bochum, Germany, 44789
        • Recruiting
        • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
        • Contact:
      • Bochum, Germany, 44791
        • Recruiting
        • UK-RUB - Katholisches Klinikum Bochum - St. Josef Hospital
        • Contact:
      • Cologne, Germany, 50937
        • Recruiting
        • Universitätsklinikum Köln
        • Contact:
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitatsklinikum Dusseldorf
        • Contact:
      • Frankfurt, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt
        • Contact:
      • Giessen, Germany, 35392
        • Recruiting
        • UKGM - Universitätsklinikum Gießen und Marburg GmbH
        • Contact:
      • Göttingen, Germany, 37075
        • Recruiting
        • Universitätsmedizin Göttingen
        • Contact:
      • Hamburg, Germany, 20251
        • Recruiting
        • Universitätsklinikum Hamburg Eppendorf
        • Contact:
      • Hamburg, Germany, 20354
        • Recruiting
        • Neurologie Neuer Wall - Dr.Bredow & Partner
        • Contact:
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
      • Homburg, Germany, 66424
        • Recruiting
        • Universitätsklinikum des Saarlandes
        • Contact:
      • Magdeburg, Germany, 39120
        • Recruiting
        • Universitätsklinikum Magdeburg A.ö.R.
        • Contact:
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsklinikum Mannheim
        • Contact:
      • Marburg, Germany, 35043
        • Recruiting
        • Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
        • Contact:
      • Minden, Germany, 32429
        • Recruiting
        • Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
        • Contact:
      • München, Germany, 80336
        • Recruiting
        • Friedrich-Baur-Institute München
        • Contact:
      • Potsdam, Germany, 14471
        • Recruiting
        • Alexianer St. Josef Potsdam GmbH
        • Contact:
      • Rüdersdorf, Germany, 15562
        • Recruiting
        • Immanuel Klinik Rüdersdorf
        • Contact:
      • Schwäbisch Hall, Germany, 74523
        • Recruiting
        • Diakonie-Klinikum Schwäbisch Hall gGmbH
        • Contact:
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Contact:
      • Ulm, Germany, 89081
        • Recruiting
        • Universitätsklinikum Ulm
        • Contact:
  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult CIDP participants considered to be initiating efgartigimod treatment per country-specific label for the treatment of CIDP

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in aINCAT score over time
Time Frame: Up to 2 years and 3 months
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
Time Frame: Up to 2 years and 3 months
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
Time Frame: Up to 2 years and 3 months
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-NIS-2501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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