Intravenous immunoglobulin (IVIg) overtreatment in chronic inflammatory demyelinating polyneuropathy (CIDP)

Phase 4

Completed

• Conditions: inflammation of nerves; Inflammatory neuropathy; 10034606

• Registration Number: NL-OMON45047
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1) Probable or definite CIDP according to the EFNS/PNS criteria 2010
2) Stable disease for 6 months (e.g. no progression of disease in last 6 months)
3) IVIg treatment for at least 6 months
4) IVIg infusion interval of 2 to 6 weeks.
5) Age of at least 18 years

Exclusion Criteria

1) Deterioration after IVIg withdrawal in the last 12 months
2) Changes in IVIg treatment dose/interval in last 6 months
3) Change of additional CIDP treatment, if any, in the last 3 months (e.g. corticosteroids or immunosuppressive treatment)
4) A prolonged period (> 6 weeks) of disability increase following an earlier IVIg withdrawal attempt
5) History of respiratory failure related to CIDP
6) Legally incompetent
7) Lack of written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For the primary outcome we will use the Rasch-Overall Disability Scale (R-ODS),<br /><br>a patient self-report linearly weighted scale that measures activity and social<br /><br>participation limitations.</p><br>