Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trials

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Subcutaneous Immunoglobulin Therapy Effectiveness Monitoring in CIDP Patients Using Smart Devices

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

Design: This is a 12-month observational study with five main clinic visits (at 0, 3, 6, 9, and 12 months). After enrolling, participants will begin or continue subcutaneous immunoglobulin therapy as decided by their treating physician. Each visit includes standard clinical assessments and questionnaires. Participants will receive a smartwatch at the start of the study to continuously track their activity and sleep patterns. A follow-up phone call one week later will check that the device is working properly. Duration: Recruitment will last about 6 months, and each participant will be followed for 12 months. Why This Matters: By combining established clinical measures with continuous digital monitoring, the S.T.E.P.S. study may help improve understanding of disease activity and treatment response in CIDP. This could lead to more personalized therapy schedules and better long-term care for patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosed typical or possible typical CIDP according to the 2021 EAN/PNS criteria

• Age ≥18 years

• Ability to use a smartwatch as decided by the investigator

• switched from IVIG to fSCIG within the prior 6 months or plan to switch during study recruitment phase

• on investigator-confirmed stable IVIG therapy pre-switch

Locations
Other Locations
Germany
University Hospital Düsseldorf
RECRUITING
Düsseldorf
University Hospital Münster
RECRUITING
Münster
Contact Information
Primary
Marc G Pawlitzki, PD Dr. med.
neuro-trials@med.uni-duesseldorf.de
+49 02118117887
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2028-01
Participants
Target number of participants: 35
Treatments
CIDP patients
CIDP patients (≥18 years) with typical or possible typical CIDP (2021 EAN/PNS criteria), Switched from IVIG to fSCIG within 6 months or during recruitment, Must be able to use smartwatch + smartphone, Exclude: CIDP variants, pregnancy, breastfeeding, inability to use devices
Sponsors
Leads: Heinrich-Heine University, Duesseldorf

This content was sourced from clinicaltrials.gov