The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies

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Brief Title

The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies

Official Title

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

Brief Summary

      To evaluate the efficacy and safety of rituximab (genetical recombination) intravenously
      administered to CIDP patients with positive or negative IgG4 autoantibody.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Rate of patients with improvement in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale

Secondary Outcome

 Change in grip strength (kPa)

Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Intervention

Rituximab (genetical recombination)

Study Arms / Comparison Groups

 Rituximab group (IgG4 autoantibody positive)
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

25

Start Date

March 28, 2019

Completion Date

May 27, 2021

Primary Completion Date

May 27, 2021

Eligibility Criteria

        Inclusion Criteria:

          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:

             (i) Patients with positive serum IgG4 autoantibody (CNTN-1 or NF-155) confirmed by the
             time of enrollment in the study

             (ii) 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
             corticosteroid 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 corticosteroid 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)

        Exclusion Criteria:

          1. Patients with disease meeting one of the following exclusion criteria defined in the
             modified EFNS/PNS diagnostic criteria (2010).

             (i) Borrelia burgdorferi infection (Lyme disease), diphtheria, drug or toxin exposure
             probably to have caused the neuropathy Hereditary demyelinating neuropathy

             (ii) Prominent sphincter disturbance

             (iii) Diagnosis of multifocal motor neuropathy

             (iv) IgM monoclonal gammopathy with high titre antibodies to myelin-associated
             glycoprotein

             (v) 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 corticosteroid 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 underwent 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
             (azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, interferon
             alpha, interferon beta, etanercept, methotrexate, mitoxantrone, alemtuzumab,
             cladribine, tacrolimus, fingolimod) within 12 weeks prior to the enrollment

          6. Patients who have underwent hematopoietic stem cell transplant prior to the enrollment

          7. Patients who have used rituximab (genetical recombination) prior to the enrollment

          8. Patients who have participated in another clinical study within 3 months prior to the
             enrollment (enrollment is allowed for those participating in a clinical study in the
             range of Indications or Dosage and Administration in Japan) or patients who are
             participating in another study

          9. Patients with poorly controlled diabetes (HbA1c of 7 % or higher)

         10. Patients who have or are suspected to have active infection (infection requiring
             treatment with systemic antimicrobial, antifungal, or antiviral agents) at the time of
             the enrollment

         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
             hepatitis B virus-DNA test is negative [below the limit of detection], 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 at the time of the
             enrollment

         12. Patients with leukopenia (less than 2,000 /mm3), neutropenia (less than 1,000 /mm3),
             or lymphopenia (less than 500 /mm3) at the time of the enrollment

         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 (e.g., hepatic, renal, cardiac, lung, hematologic,
             or brain disease)

         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
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Masahiro Iijima, Ph. D, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT03864185

Organization ID

CAMCR-011

Secondary IDs

jRCT2041180037

Responsible Party

Principal Investigator

Study Sponsor

Nagoya University

Collaborators

 Japan Agency for Medical Research and Development

Study Sponsor

Masahiro Iijima, Ph. D, Principal Investigator, Nagoya University Hospital


Verification Date

August 2021