Using rituximab to achieve remission in patients with chronic inflammatory demyelinating polyneuropathy
Rituximab Induced Remission in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
This study is testing if rituximab can help people with chronic inflammatory demyelinating polyneuropathy feel better and reduce their need for other treatments.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | rituximab, chemotherapy |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06714838 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if rituximab can induce remission in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). It will involve two groups of patients: those who are newly diagnosed and those who are already on maintenance treatment with immunoglobulins. Participants will receive rituximab infusions at the start of the trial and again at six months, alongside IVIg treatment for newly diagnosed patients. The study will assess the effectiveness of rituximab in reducing the need for ongoing IVIg therapy and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a confirmed diagnosis of CIDP, either newly diagnosed or currently on maintenance treatment.
Not a fit: Patients who do not meet the eligibility criteria or have other underlying conditions that complicate CIDP may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to long-term remission for CIDP patients, reducing their reliance on regular immunoglobulin infusions.
How similar studies have performed: Previous studies have shown promising results for rituximab in treating refractory CIDP, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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
Inclusion Criteria 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 categories:
1. 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)
2. 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)
3. 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
Exclusion Criteria:
* 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 IgA deficiency patients who developed antibodies to IgA.
* 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 the entire duration of the study.
* No written informed consent
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Filip Eftimov, MD PHD
- Email: f.eftimov@amsterdamumc.nl
- Phone: +31205669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.