Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy

Sponsor
Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)
Study ID
NCT06714838
Phase
PHASE3
Status
Recruiting
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Conditions

  • CIDP

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab (Mabthera) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 16, 2024
Status verified
Dec 2024
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Remission at 52 weeks [ Time Frame: Baseline to 52 weeks ]

Central Contacts

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