Brief Title
Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
Official Title
A Multicenter Pilot Study to Determine Criteria for Evaluating the Effectiveness of Two Comparative Monitoring Methods in the Management of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Receiving Home-based Treatment With IVIg (Privigen®)
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.
Study Type
Observational
Primary Outcome
Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy
Condition
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention
HOME LINK
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
11
Start Date
November 27, 2017
Completion Date
June 3, 2019
Primary Completion Date
June 3, 2019
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03779828
Organization ID
IgPro10_5004
Secondary IDs
2016-A00147-44
Responsible Party
Sponsor
Study Sponsor
CSL Behring
Study Sponsor
, ,
Verification Date
January 2021