Intravenous immunoglobulin overtreatment in chronic inflammatory demyelinating polyneuropathy

Not Applicable

Completed

• Conditions: Chronic inflammatory demyelinating polyneuropathy (CIDP); Nervous System Diseases; Inflammatory polyneuropathy

• Registration Number: ISRCTN13637698
• Lead Sponsor: Academic Medical Center Amsterdam (Netherlands)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35139161/ (added 01/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-25
• Study Completion: 2019-07-31
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Probable or definite CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010
2. Stable disease for 6 months (i.e., no progression of disease in the last 6 months)
3. IVIg treatment for at least 6 months
4. IVIg infusion interval of 2 to 6 weeks
5. Age > 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
The change between baseline and endpoint Rasch-Overall Disability Score (R-ODS). An endpoint will be reached in case of one of the following: final visit at 24 weeks or deterioration on the R-ODS by more than 0.652 logits during follow-up.