JPRN-jRCTs041210046
Completed
Phase 2
The Evaluation of Efficacy and Safety of Additional Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the 2nd Exploratory Clinical Study in Patients Requested Medical Care - RECIPE-2 Study
Katsuno Masahisa0 sites5 target enrollmentAugust 3, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Refractory Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Sponsor
- Katsuno Masahisa
- Enrollment
- 5
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with definite CIDP diagnosed according to the modified diagnostic criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) (2010\) by the time of enrollment in the study
- •2\. Patients with positive serum IgG4 autoantibody (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 enrollment
- •5\. Patients meeting one of the following conditions:
- •1\) Patients received rituximab (genetical recombination) IV infusion for CIDP treatment
- •2\) Patients received rituximab (genetical recombination) or placebo IV infusion in RECIPE trial participant
- •6\. Patients aged 20 years or older at informed consent
- •7\. Patients who give their voluntary written consent after having received adequate information on this study
Exclusion Criteria
- •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 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)
Outcomes
Primary Outcomes
Not specified
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