Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06714838

Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

Led by Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC) · Updated on 2024-12-04

100

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

Sponsors

A

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

Lead Sponsor

S

Stichting Treatmeds

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with CIDP according to EAN/PNS criteria
  • For new patients: untreated and aged 18 to 80 years
  • For new patients: sufficient CIDP-related disability to need IVIg and rituximab treatment
  • For patients on maintenance treatment: stable IVIg/SCIg dose for at least 3 months and meet criteria of wear-off symptoms, failed withdrawal, or increased Ig dose with improvement
  • Men and women aged 18 to 80 years
  • Able to give signed informed consent
Not Eligible

You will not qualify if you...

  • Paranodopathy with (paranodal) antibodies
  • Use of drugs causing demyelinating neuropathy in the last 6 months
  • Serious adverse reactions to IVIg or rituximab or hypersensitivity to these or their components
  • Known selective IgA deficiency with antibodies to IgA
  • Active hepatitis B or C infection
  • Ongoing immunosuppressive treatment except corticosteroids discontinued more than 6 months ago
  • IVIg interval of 6 weeks or more (Group 2 only)
  • Obesity with BMI over 35
  • Active malignancy not in remission or life expectancy under 1 year
  • History of recurrent or chronic infections
  • Active severe infections such as tuberculosis or sepsis
  • Severe immunocompromised state
  • Severe heart failure or uncontrolled cardiac disease
  • Serious co-morbidities as judged by physician
  • Pregnancy, nursing, or intention to become pregnant without reliable contraception
  • No written informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, Netherlands, 1105AZ

Actively Recruiting

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Research Team

F

Filip Eftimov, MD PHD

CONTACT

S

Stevie Rozing, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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