Actively Recruiting
Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Led by Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC) · Updated on 2024-12-04
100
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
A
Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)
Lead Sponsor
S
Stichting Treatmeds
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with CIDP according to EAN/PNS criteria
- For new patients: untreated and aged 18 to 80 years
- For new patients: sufficient CIDP-related disability to need IVIg and rituximab treatment
- For patients on maintenance treatment: stable IVIg/SCIg dose for at least 3 months and meet criteria of wear-off symptoms, failed withdrawal, or increased Ig dose with improvement
- Men and women aged 18 to 80 years
- Able to give signed informed consent
You will not qualify if you...
- Paranodopathy with (paranodal) antibodies
- Use of drugs causing demyelinating neuropathy in the last 6 months
- Serious adverse reactions to IVIg or rituximab or hypersensitivity to these or their components
- Known selective IgA deficiency with antibodies to IgA
- Active hepatitis B or C infection
- Ongoing immunosuppressive treatment except corticosteroids discontinued more than 6 months ago
- IVIg interval of 6 weeks or more (Group 2 only)
- Obesity with BMI over 35
- Active malignancy not in remission or life expectancy under 1 year
- History of recurrent or chronic infections
- Active severe infections such as tuberculosis or sepsis
- Severe immunocompromised state
- Severe heart failure or uncontrolled cardiac disease
- Serious co-morbidities as judged by physician
- Pregnancy, nursing, or intention to become pregnant without reliable contraception
- No written informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands, 1105AZ
Actively Recruiting
Research Team
F
Filip Eftimov, MD PHD
CONTACT
S
Stevie Rozing, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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