Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jüdisches Krankenhaus Berlin, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

efgartigimod PH20 SC

Biological

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

Primary outcomes

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).
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.
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

The EQ-5D-5L questionnaire is a patient-reported outcome measure, ranging 0 to 100 (lower score, worse outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Dec 4, 2025
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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