Chronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
Conditions
Brief 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.
Interventions
BIOLOGICALEfgartigimod PH20 SC
Efgartigimod treatment per country-specific label for the treatment of CIDP
Sponsors
argenx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany, United States
Contacts
CONTACTSabine Coppieters, MD
Outcome results
None listed