An international, multicentre, efficacy and safety study of I10E ininitial and maintenance treatment of patients with ChronicInflammatory Demyelinating Polyradiculoneuropathy - PRISM

FB BIOTECHNOLOGIES0 个研究点目标入组 42 人开始时间: 2014年8月27日最近更新: 2017年10月30日

试验速览

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•1. Male or female patient aged 18 years or more.
•2. - Definite or probable CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and neurophysiological criteria.
•- Pure motor CIDP, provided that a diagnosis of multifocal motor neuropathy has been ruled out.
•- CIDP associated with monoclonal gammopathy of undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA technique).
•- Lewis-Sumner syndrome.
•3. Score of at least 2 on the adjusted INCAT disability scale.
•4. Patient who either :
•a) has never been previously treated with Ig (Ig-naive patient)
•b) was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening.
•5. Covered by national healthcare insurance system as required by local regulations.
•6. Written informed consent obtained prior to any study-related procedures.
•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 38
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1. History of severe allergic reaction or serious adverse reaction to any immunoglobulin (Ig).
•2. Clinically documented lack of response to previous Ig treatment.
•3. History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented.
•4. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
•5. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
•6. History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident.
•7. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy.
•8. History of personal or familial congenital thrombophilia or acquired thrombophilia.
•9. Factors contributing to venous stasis such as long-term bed confinement.
•10. Body mass Index (BMI) >/= 40 kg/m².
•11. Protein-losing enteropathy characterised by serum protein levels <60 g/L and serum albumin levels <30 g/L or nephrotic syndrome characterised by proteinuria >/= 3.5 g/24hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
•12. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) calculation.
•13. Serum levels of alanine aminotransferase (AST) or aspartate aminotransferase (ALT), >2 times upper limit of normal range.

发起方

FB BIOTECHNOLOGIES