RecruitingRare disease

Study on Rituximab for Achieving Remission in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a neurological disorder that causes weakness and impaired sensory function in the legs and arms. The study will explore the effects of a treatment using a medication called Rituximab, which is also known by other names such as CT-P10, PF-05280586, and ABP 798. Rituximab is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein.

The purpose of the study is to determine if adding Rituximab to a limited period of another treatment called IVIg (intravenous immunoglobulin) can lead to long-term remission of CIDP. Remission means that the symptoms of the disease are reduced or disappear for a period of time. The study aims to see if this combination can help patients stop needing regular IVIg infusions, which can be inconvenient and costly.

Participants in the study will receive Rituximab and will be monitored over a period of time to see if they achieve remission at 52 weeks after starting the treatment. The study will also check if the treatment remains effective at 104 weeks. The goal is to find out if Rituximab can help patients with CIDP maintain stability without needing additional treatments. The study is expected to continue until 2028.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Upon joining the study, the treatment begins with the administration of Rixathon 500 mg, a concentrate for solution for infusion. This medication contains rituximab and is given through an intravenous infusion.
The purpose of this step is to initiate the process of remission in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Step 2
Administration schedule
The treatment involves a limited period of intravenous immunoglobulin (IVIg) therapy in combination with rituximab. The specific dosage and frequency of administration will be determined by the healthcare provider based on individual patient needs.
The goal is to achieve long-term remission and eventually discontinue the regular IVIg infusions.
Step 3
Monitoring and assessment
Throughout the study, regular monitoring and assessments will be conducted to evaluate the patient's response to the treatment.
The primary endpoint is to achieve remission at 52 weeks after the start of rituximab treatment, meaning no additional treatment is needed after this period.
Step 4
Follow-up
A follow-up period extends to 104 weeks to ensure stability on the treatment.
During this time, the patient's condition will be closely observed to confirm the effectiveness and safety of the treatment.

Who can join the trial?

8 criteria

Must have **Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)**, a condition affecting the nerves.
For new patients: Must meet the **EAN/PNS criteria** for CIDP, which are specific guidelines used to diagnose the condition.
For new patients: Must not have received any treatment for CIDP yet.
For patients already on treatment: Must be on a stable dose of **IVIg** (intravenous immunoglobulin) or **SCIg** (subcutaneous immunoglobulin) for at least 3 months or 4 infusions.
For patients already on treatment: Must have experienced certain symptoms or changes in treatment, such as symptoms returning before the next infusion, a failed attempt to stop treatment, or an increase in dose leading to improvement.
Must be between 18 and 80 years old.
Must have a level of disability related to CIDP that requires treatment with IVIg and **RTX** (a type of medication).
Must be able to understand the study and sign a consent form agreeing to participate.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) cannot participate. CIDP is a condition that affects the nerves, causing weakness and numbness.
Patients who are younger than 18 years old or older than 65 years old are not eligible to participate.
Both male and female patients can participate, but those who are part of a vulnerable population, such as pregnant women or those unable to give consent, are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Rituximab
is a medication used in this study to help achieve remission in patients with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy). It works by targeting specific cells in the immune system that are thought to contribute to the disease. The goal is to see if adding Rituximab to the treatment can lead to long-term remission, allowing patients to stop other treatments and reduce the need for regular infusions.
IVIg (Intravenous Immunoglobulin)
is a therapy that involves infusing antibodies into the bloodstream. It is commonly used to treat CIDP by helping to reduce inflammation and improve nerve function. In this study, IVIg is used for a limited period to see if it can help achieve remission when combined with Rituximab.

Rituximab

What is already known about the treatment

Rituximab – Rituximab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied for its effectiveness in treating chronic inflammatory demyelinating polyneuropathy (CIDP), a condition characterized by nerve damage. The main therapeutic indication for Rituximab in this context is to induce remission in CIDP patients, potentially allowing them to discontinue regular immunoglobulin infusions. At the molecular level, Rituximab works by targeting and depleting B-cells, a type of white blood cell involved in the immune response, which can help reduce inflammation and nerve damage. It is classified as a monoclonal antibody, a type of medication designed to specifically target certain cells in the body.

Investigated diseases

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – This is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. CIDP is considered an autoimmune disorder, where the body's immune system mistakenly attacks its own nerve tissues. Symptoms often include tingling or numbness, muscle weakness, and loss of deep tendon reflexes. The progression of CIDP can vary, with some individuals experiencing a steady worsening of symptoms, while others may have periods of improvement followed by relapses. The condition can lead to significant physical disability if not managed appropriately.