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

agoya University Hospital0 sites27 target enrollmentFebruary 2, 2019

ConditionsChronic Inflammatory Demyelinating Polyneuropathy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
Sponsor: agoya University Hospital
Enrollment: 27
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 2, 2019

End Date

June 2, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

agoya University Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. Patients with disease meeting one of the following exclusion criteria defined in the modified EFNS/PNS diagnostic criteria. 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) 5\. Patients who have started or have increased the dose of an immunosuppressant within 12 weeks prior to the enrollment 6\. Patients who have undergone hematopoietic stem cell transplant prior to the enrollment 7\. Patients who have used rituximab prior to the enrollment 8\. Patients who have participated in another clinical study within 3 months prior to the enrollment or patients who are participating in another study 9\. Patients with poorly controlled diabetes 10\. Patients who have or are suspected to have active infection 11\. Patients tested positive for HBs antigen, HBs antibody, HBc antibody, and/or HCV antibody(patients with positive HBs antibody or HBc antibody can be enrolled when a HBV\-DNA test is negative, and hepatitis B virus\-DNA and aspartate/alanine transaminase levels are monitored at fixed intervals), or patients with positive HIV antibody or HTLV\-1 antibody 12\. Patients with leukopenia, neutropenia, or lymphopenia 13\. Patients with history of serious hypersensitivity or anaphylactic reaction to one of the ingredients in the investigational drug or murine protein\-containing products 14\. Patients with serious comorbidity 15\. Female patients who are pregnant, lactating, or potentially pregnant, or patients who are not willing to use contraceptive measures during the study period 16\. Patients who are judged to be unsuitable by the investigator or a sub\-investigator