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

NCT03864185 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-08-20

No results posted yet for this study

Summary

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

Conditions

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Interventions

BIOLOGICAL

Rituximab (genetical recombination)

Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.

OTHER

Placebo

Administer placebo IV infusion once weekly for 4 doses.

Sponsors & Collaborators

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • Zenyaku Kogyo Co., Ltd.

    collaborator INDUSTRY

  • Nagoya University

    lead OTHER

Principal Investigators

  • Masahiro Iijima, Ph. D · Nagoya University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2021-05-27
Completion
2021-05-27

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03864185 on ClinicalTrials.gov