Chronic Inflammatory Demyelinating PolyradiculoneuropathyNCT07264426
Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy and CIDP, run by argenx at 23 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
- What is being tested?
- Efgartigimod PH20 SC
- How many people
- 200 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 11 Aug 2025to Oct 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult CIDP participants considered to be initiating efgartigimod treatment per country-specific label for the treatment of CIDP
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 2 countries
Germany22 sites, 21 recruiting
- Recruiting
Jüdisches Krankenhaus Berlin
Berlin, 13347
Juliane Klehmet, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH
Bochum, 44789
Felix Kleefeld, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
UK-RUB - Katholisches Klinikum Bochum - St. Josef Hospital
Bochum, 44791
Anna Fisse, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Köln
Cologne, 50937
Michael Schroeter, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Michael Gliem, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt, 60590
Yavor Yalachkov, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
UKGM - Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392
Heidrun Krämer-Best, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsmedizin Göttingen
Göttingen, 37075
Jana Zschuentzsch, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20251
Mathias Gelderblom, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Neurologie Neuer Wall - Dr.Bredow & Partner
Hamburg, 20354
Karl Christian Knop, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Aiden Haghikia, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitatsklinikum des Saarlandes
Homburg, 66424
Fatma Merzou, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, 39120
Heike Stephanik, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 68167
Hans-Werner Rausch, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg
Marburg, 35043
Clemens Warnke, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
Minden, 32429
Jörg Philipps, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Friedrich-Baur-Institute München
München, 80336
Stephan Wenninger, MD, 857-350-4834, clinicaltrials@argenx.com
- Completed
Alexianer St. Josef Potsdam GmbH
Potsdam, 14471
- Recruiting
Immanuel Klinik Rüdersdorf
Rüdersdorf, 15562
Karsten Kummer, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Diakonie-Klinikum Schwäbisch Hall gGmbH
Schwäbisch Hall, 74523
Benjamin Knier, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
Alexander Grimm, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Universitätsklinikum Ulm
Ulm, 89081
Johannes Dorst, MD, 857-350-4834, clinicaltrials@argenx.com
United States1 site, 1 recruiting
- Recruiting
PPD Virtual
Wilmington, North Carolina, 28401
Neil Brett, MD, 857-350-4834, clinicaltrials@argenx.com
About this 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.
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
- Being tested
- Efgartigimod PH20 SC
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod PH20 SCBiological
Efgartigimod treatment per country-specific label for the treatment of CIDP
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 2 years and 3 months
Change in grip strength over time
Measured: 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)
Measured: Up to 2 years and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start11 Aug 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264426
- Sponsor's protocol ID
- ARGX-113-NIS-2501
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No