The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial

Iijima Masahiro0 sites25 target enrollmentJanuary 31, 2019

Overview

No summary available.

Registry

who.int

Start Date

January 31, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Iijima Masahiro

•1\.Patients with definite CIDP diagnosed according to the modified diagnostic criteria of European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) (2010\) by the time of enrollment in the study
•2\.Patients meeting one of the following conditions:
•1\)Patients with positive serum IgG4 autoantibody (CNTN\-1 or NF\-155\) confirmed by the time of enrollment in the study
•2\)Patients with negative serum IgG4 autoantibody (CNTN\-1 and NF\-155\) confirmed by the time of enrollment in the study
•3\.Patients with refractory CIDP not responding adequately to treatment with corticosteroids for 12 weeks, and intravenous immunoglobulin therapy (IVIg) for 8 weeks by the time of enrollment in the study, or those who are unable to administer or continue corticosteroids and IVIg
•4\.Patients with total adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale scores of 2 to 8 at both preliminary enrollment and enrollment, and with the total score at enrollment equal to or worse than that at preliminary enrollment
•5\.Patients aged 12 years or older at informed consent
•6\.Patients who give their voluntary written consent after having received adequate information on this study (legally acceptable representatives should also give consent for underage patients, and informed assent should be obtained from children aged 12 to 15\)

•1\.Patients with disease meeting one of the following exclusion criteria defined in the modified EFNS/PNS diagnostic criteria (2010\).
•1\)Borrelia burgdorferi infection (Lyme disease), diphtheria, drug or toxin exposure probably to have caused the neuropathy Hereditary demyelinating neuropathy
•2\)Prominent sphincter disturbance
•3\)Diagnosis of multifocal motor neuropathy
•4\)IgM monoclonal gammopathy with high antibody titers to myelin\-associated glycoprotein
•5\)Other causes for a demyelinating neuropathy including POEMS syndrome, osteosclerotic myeloma, diabetic and non\-diabetic lumbosacral radiculoplexus neuropathy
•PNS lymphoma and amyloidosis may occasionally have demyelinating features
•2\.Patients who have started or have increased the dose of corticosteroids for CIDP within 12 weeks prior to the enrollment
•3\.Patients who have started or have increased the dose of IVIg within 8 weeks prior to the enrollment
•4\.Patients who have undergone plasmapheresis within 8 weeks prior to the enrollment or patients with refractory disease not responding adequately to 8 weeks of plasmapheresis (plasma exchange or double\-filtration plasmapheresis)