Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Efgartigimod PH20 SC: Efgartigimod treatment per country-specific label for the treatment of CIDP

Study 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.

Eligibility

Primary outcome measure(s)

• Change in aINCAT score over time — 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 — 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 — Up to 2 years and 3 months
• Change in EQ-5D value from index date over time — 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)

Trial sites (23)

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