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
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
- Registration Number
- JPRN-UMIN000035753
- Lead Sponsor
- agoya University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 27
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adjusted INCAT Disability Scale
- Secondary Outcome Measures
Name Time Method 1) Grip strength (left/right) 2) Rasch-built Overall Disability Scale (R-ODS) 3) Medical Research Council (MRC) Sum Score 4) Nerve conduction study (motor nerves: median, ulnar, tibial, and peroneal nerves) 5) Cerebrospinal fluid protein level 6) B cell counts (CD19 positive and CD20 positive cell counts) and T cell counts (CD3 positive, CD4 positive, and CD8 positive cell counts) 7) Expression of human anti-chimeric antibodies (HACA) 8) Serum rituximab (genetical recombination) level 9) Serum antibody titers of IgG4 (CNTN-1 and NF-155) and these IgG subclasses 10) Serum neurofilament 11) Adverse events 12) Vital signs, laboratory values