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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Efgartigimod PH20 SC
Biological/VaccineEfgartigimod treatment per country-specific label for the treatment of CIDP
Treatment groups
Trial outcomes
Primary outcomes
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).
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.
Change in grip strength over time
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)