Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• Capable of giving signed informed consent

• CIDP according to the European association of neurology/Peripheral nerve society (EAN/PNS) criteria (1) on maintenance treatment (stable dose/interval of at least 4 infusions or 3 months), including one of the following categories:

‣ patients with wear-off symptoms before next IVIg infusion captured by at least the minimal clinical important difference (MCID) on at least one outcome measure (see below)

⁃ patients with a failed withdrawal attempt in the last 12 months captured by at least an MCID on at least one outcome measure (see below)

⁃ patients with an increase of IVIg/SCIg dose/interval in the last 12 months leading to improvement by at least the MCID on at least one outcome measure, see below.

‣ The most commonly used MCID criteria, namely: 1) one point on the aINCAT disability score (1-10); 2) 4 points on a centile score on I-RODS (disability, 1-100); 3) 2 points on the MRC sum score (muscle strength, 0-60) and 4) 8 kPa on Vigorimeter (grip strength, single or both arms, variable range).

• Men and women aged between 18 and 80 years

• Capable of giving signed informed consent

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Filip Eftimov, MD PHD
f.eftimov@amsterdamumc.nl
+31205669111
Backup
Stevie Rozing, MD
s.c.e.rozing@amsterdamumc.nl
Time Frame
Start Date: 2024-10-16
Estimated Completion Date: 2028-10
Participants
Target number of participants: 100
Treatments
Experimental: Single arm: all patients receive rituximab
All patients will receive rituximab at baseline (1000 mg) and after two weeks (1000 mg). Then, depending of whether the patient shows improvement in the following three to six months, the patient will receive another dose of rituximab (500 mg) at six months.
Sponsors
Collaborators: UMC Utrecht, Stichting Treatmeds, Erasmus Medical Center
Leads: Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)

This content was sourced from clinicaltrials.gov