Intravenous immunoglobulin overtreatment in CIDP
- Conditions
- Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-005363-52-NL
- Lead Sponsor
- Department of Neurology, Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1) Probable or definite CIDP according to the EFNS/PNS criteria 20103
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 > 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method