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

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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