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

NCT ID: NCT03779828

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-27

Study Completion Date

2019-06-03

Brief Summary

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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

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Conditions

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Chronic Inflammatory Demyelinating Polyneuropathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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HOME LINK

Telemonitoring system which include web platform and connected devices.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not applicable
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Pellegrin, Bordeaux University Hospital (CHU)

Bordeaux, , France

Site Status

Hôpital Henri Mondor - APHP

Créteil, , France

Site Status

Hôpital Roger Salengro - CHRU

Lille, , France

Site Status

Hôpital Pierre Wertheimer - HCL

Lyon, , France

Site Status

Hôpital La Timone - APHM

Marseille, , France

Site Status

Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)

Montpellier, , France

Site Status

Hôpital Pasteur 2 - Nice University Hospital (CHU)

Nice, , France

Site Status

Hôpital La Pitié-Salpêtrière - APHP

Paris, , France

Site Status

Hôpital Lariboisière - APHP

Paris, , France

Site Status

Hôpital Nord - Saint Etienne University Hospital (CHU)

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2016-A00147-44

Identifier Type: OTHER

Identifier Source: secondary_id

IgPro10_5004

Identifier Type: -

Identifier Source: org_study_id

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