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.
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
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))
Single group
Rituximab (Mabthera)
DrugRituximab 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.
Remission at 52 weeks
In order to assess efficacy of RTX: Remission at 52 weeks after start of RTX, i.e., no need of additional treatment after RTX treatment. For Group 1, remission is defined as sustained improvement, without the need for further treatment. Improvement will be defined as decrease in disability by at least the minimal clinical important difference (MCID) on the adjusted INCAT (aINCAT) disability scale and/or the Inflammatory-Rasch Overall Disability Scale (I-RODS). Sustained is defined as no deterioration after maximal improvement achieved in week 13 to 26. For Group 2, remission is defined as no change in disability (MCID) between start of Ig withdrawal and week 52.
Stability on treatment at 104 weeks of follow-up.
Explore the feasibility of introducing rituximab as alternative maintenance treatment in patients with CIDP in patients who experience a relapse after at least 6 months after last RTX treatment (long term follow-up): Definition for stability is similar to the primary outcome for Group 2, which is remission, defined as no change in disability (MCID) between weeks 52 and 104.
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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
