MedTrace Logo

Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

NCT06714838 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-04

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the drug called rituximab causes remission in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The aim is to investigate this in two types of patients, those who are newly diagnosed, and those who are already being treated and are dependent on the current standard therapy: immunoglobulins administered through infusion (IVIg) or through injection (SCIg). The main questions this trial aims to answer are:

* To assess the effectiveness of rituximab
* Whether it is possible and useful to prescribe patients rituximab who experience a relapse after at least six months after their last rituximab treatment.

Participants will:

* Receive the drug rituximab twice at the beginning of the trial and one additional time at six months.
* The newly diagnosed patients will also start another treatment called IVIg, which a nurse will administer every three weeks during the first three to six months.
* The patients who already being treated, will continue their regular treatment, until this is slowly reduced and stopped, during months three to six.
* Visit the clinic over the course of two years, during which they will have approximately 10 visits, for checkups and tests.
* Be asked to fill in questionnaires at each visit, and be asked to have their blood drawn four times.

Conditions

Interventions

DRUG

Rituximab (Mabthera)

Rituximab will be administered in a hospital setting in the course of one day. It will be given intravenously, at time points baseline, week 2 and week 26.

Sponsors & Collaborators

  • Stichting Treatmeds

    collaborator UNKNOWN

  • UMC Utrecht

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2027-10-31
Completion
2028-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT06714838 on ClinicalTrials.gov