Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

ConditionCIDP
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAmsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)

About this trial

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.

Eligibility criteria

Qualifiers

CIDP according to the EAN/PNS criteria (1)

Untreated

Men and women aged between 18 and 80 years

Sufficient CIDP-related disability, as judged by treating physician to warrant IVIg and RTX treatment

Disqualifiers

Paranodopathy with demonstrated (paranodal) antibodies, previously considered part of CIDP spectrum (in these cases rituximab is preferred treatment)

Use of drugs associated with a demyelinating neuropathy in the last six months.

Known serious adverse events with previous IVIg or RTX treatment. Hypersensitivity to RTX or any component of the formulation. Hypersensitivity to the human immunoglobulins or to any of the excipients. Known selective IgA deficiency patients who developed antibodies to IgA.

Positive hepatitis B and C serology suggesting active/untreated infection (HBsAg, anti-HB core en anti-HBs and HCV antibody (IgG))

Trial design

Treatments tested in this trial

  • Rituximab (Mabthera)

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

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

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution

Stichting Treatmeds

Collaborator

UMC Utrecht

Collaborator

Erasmus Medical Center

Collaborator