Intravenous immunoglobulin overtreatment in chronic inflammatory demyelinating polyneuropathy: a randomized controlled non-inferiority trial

Academic Medical Center Amsterdam (Netherlands)0 个研究点目标入组 60 人开始时间: 2014年3月25日最近更新: 2022年11月14日

适应症

试验速览

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

•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

•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

发起方

Academic Medical Center Amsterdam (Netherlands)