Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

NCT07264426 | Recruiting FDA Drug

• 1 other identifier: ARGX-113-NIS-2501
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 23

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Efgartigimod PH20 SC BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

Study Sites (23)

PPD Virtual

Wilmington, North Carolina, 28401, United States

RECRUITING

Jüdisches Krankenhaus Berlin

Berlin, 13347, Germany

RECRUITING

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH

Bochum, 44789, Germany

RECRUITING

UK-RUB - Katholisches Klinikum Bochum - St. Josef Hospital

Bochum, 44791, Germany

RECRUITING

Universitätsklinikum Köln

Cologne, 50937, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

RECRUITING

UKGM - Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35392, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

RECRUITING

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20251, Germany

RECRUITING

Neurologie Neuer Wall - Dr.Bredow & Partner

Hamburg, 20354, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitatsklinikum des Saarlandes

Homburg, 66424, Germany

RECRUITING

Universitätsklinikum Magdeburg A.ö.R.

Magdeburg, 39120, Germany

RECRUITING

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg

Marburg, 35043, Germany

RECRUITING

Mühlenkreiskliniken - Johannes Wesling Klinikum Minden

Minden, 32429, Germany

RECRUITING

Friedrich-Baur-Institute München

München, 80336, Germany

RECRUITING

Alexianer St. Josef Potsdam GmbH

Potsdam, 14471, Germany

RECRUITING

Immanuel Klinik Rüdersdorf

Rüdersdorf, 15562, Germany

RECRUITING

Diakonie-Klinikum Schwäbisch Hall gGmbH

Schwäbisch Hall, 74523, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DE (22)