Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP

Terminated

• Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

• Registration Number: NCT03779828
• Lead Sponsor: CSL Behring

Brief Summary

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating polyneuropathy of autoimmune origin with a progressive or relapsing course.

Diagnosis is based on clinical presentation and electrophysiological findings in accordance with the EFNS/PNS consensus guidelines. IVIg is the first line treatment witch has been shown to be effective in several placebo-controlled trials.

Once IVIg therapy produces a response and is well tolerated, some patients are able to continue their treatment in the home setting. The HOME LINK system offers an integrated, global solution based on telemonitoring technology providing continuous, remote monitoring of Privigen® infusions administered at home.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-27
• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Primary Completion: 2019-06-03
• Study Completion: 2019-06-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Patient with a diagnosis of CIDP as per EFNS/PNS criteria.
• Patient already receiving home-based treatment with Privigen®

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Exclusion Criteria

• Not applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy	52 weeks	The conventional method of home monitoring requires using a visiting nurse. HOME LINK is a telemonitoring system that is an alternative to this conventional method offering remote at-home monitoring. HOME LINK monitors the patient's health parameters from home. In this way it enables an adjustment of the infusion conditions or intervention of a qualified healthcare professional in the event of an incident. Home Link will be evaluated for failure rate of connection to the telemonitoring platform, failure rate of transmission of self-measurements to the telemonitoring platform, failure rate of transmission of documents relating to home-based treatment, and failure rate of contacting one of the healthcare professionals involved in patient care during the at-home infusions.

Trial Locations

Locations (10)

Hôpital Pellegrin, Bordeaux University Hospital (CHU); 🇫🇷 Bordeaux, France

Hôpital Henri Mondor - APHP; 🇫🇷 Créteil, France

Hôpital Roger Salengro - CHRU; 🇫🇷 Lille, France

Hôpital Pierre Wertheimer - HCL; 🇫🇷 Lyon, France

Hôpital La Pitié-Salpêtrière - APHP; 🇫🇷 Paris, France

Hôpital La Timone - APHM; 🇫🇷 Marseille, France

Hôpital Pasteur 2 - Nice University Hospital (CHU); 🇫🇷 Nice, France

Hôpital Lariboisière - APHP; 🇫🇷 Paris, France

Hôpital Gui de Chauliac - Montpellier University Hospital (CHU); 🇫🇷 Montpellier, France

Hôpital Nord - Saint Etienne University Hospital (CHU); 🇫🇷 Saint Etienne, France