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Rituximab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

NCT06325943 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-03-26

No results posted yet for this study

Summary

Randomized double-blind controlled study of rituximab versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on chronic treatment with immunoglobulins. The primary objective of the study is to determine whether rituximab treatment is effective in preventing the disease from getting worse after stopping immunoglobulin treatment for six months in patients with CIDP. The secondary objective is to evaluate whether treatment with rituximab can improve the response to therapy compared to placebo in patients treated with immunoglobulins and whether it can allow to delay the mean time of worsening after discontinuation of immunoglobulin therapy.

Exploratory objectives are the correlation between response to rituximab therapy and the clinical form of CIDP and the presence of antibody reactivity against node of Ranvier antigens. Intervention will be Rituximab or placebo, 1 g by intravenous infusion on day 1 and 15 after randomization and concomitant treatment for 6 months with intravenous or subcutaneous immunoglobulin at the same dosage as before randomization.

Conditions

  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

DRUG

Rituximab

Patients will receive two doses of rituximab 1 g at two-week interval and one dose of rituximab 1 g at month 6

OTHER

Placebo

Patients will receive two doses of placebo at two-week interval and one dose of placebo at month 6

Sponsors & Collaborators

  • Ospedale Mondino di Pavia

    collaborator UNKNOWN

  • University of Turin, Italy

    collaborator OTHER

  • Istituto Neurologico Carlo Besta di Milano

    collaborator UNKNOWN

  • San Raffaele University Hospital, Italy

    collaborator OTHER

  • Università di Messina

    collaborator UNKNOWN

  • Universita degli Studi di Genova

    collaborator OTHER

  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER

  • Università di Napoli Federico II

    collaborator UNKNOWN

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2023-05-30
Completion
2023-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT06325943 on ClinicalTrials.gov