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The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03864185•Nagoya University

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Summary

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

•(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
+10 more criteria

Locations (4)

Nagoya University Hospital

Nagoya, Aich, Japan

Chiba University Hospital

Chiba, Japan

Kyushu University Hospital

Fukuoka, Japan

Yamaguchi University Hospital

Ube, Japan

Key Dates

Start Date

March 28, 2019

Primary Completion Date

May 27, 2021

Completion Date

May 27, 2021

Last Updated

August 20, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Interventions

Rituximab (genetical recombination)

BIOLOGICAL

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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