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New treatment option for CIDP
Official title Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
ClinicalTrials.gov ID: NCT06714838
What this study is testing
What is Rituximab (Mabthera)?
Rituximab (Mabthera) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cidp.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Group 1 (new/untreated patients):
- 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
You likely can't join if
- 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...
- Positive hepatitis B and C serology suggesting active/untreated infection (HBsAg, anti-HB core en anti-HBs and HCV antibody (IgG))
- Ongoing immunosuppressive treatment for other indications.
- Immunosuppressive treatment other than (already discontinued) corticosteroids in last 6 months.
See the full eligibility criteria
- Group 1 (new/untreated patients):
- 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 Group 2 (patients on maintenance treatment):
- 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...
- 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...
- Men and women aged between 18 and 80 years
- Capable of giving signed informed consent
- 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...
- Positive hepatitis B and C serology suggesting active/untreated infection (HBsAg, anti-HB core en anti-HBs and HCV antibody (IgG))
- Ongoing immunosuppressive treatment for other indications.
- Immunosuppressive treatment other than (already discontinued) corticosteroids in last 6 months.
- IVIg interval of once every 6 weeks or more than 6 weeks (applies to Group 2 only)
- Obesity (BMI \> 35)
- Known active malignancy (not in remission), currently treated with chemotherapy or immunomodulatory drugs, or with a life expectancy of less than 1 year.
- History of recurrent/chronic infections
- Active, severe infections (such as tuberculosis, sepsis and opportunistic infections)
- Patients in a severely immunocompromised state Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
- Serious co-morbidity as judged by treating physician.
- Pregnancy or nursing mother; intention to become pregnant during the course of the study; female patients of childbearing potential either not using or not willing to use a medically reliable method of contraception for...
- No written informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.