Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
Sponsorargenx

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Efgartigimod PH20 SC

    Biological/Vaccine

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 2 years and 3 months
2

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.

Time frame
Up to 2 years and 3 months
3

Change in grip strength over time

Time frame
Up to 2 years and 3 months
4

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)

Time frame
Up to 2 years and 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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