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
52 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
Researchers are studying whether the drug rituximab can cause remission in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The trial includes two groups: newly diagnosed patients starting standard immunoglobulin treatment and patients already dependent on immunoglobulin therapy. The goal is to assess the effectiveness of rituximab, including its use after relapse following previous rituximab treatment, to potentially reduce the need for ongoing immunoglobulin therapy. All participants will receive rituximab infusions twice at the start and once more at six months. Newly diagnosed patients will also receive immunoglobulin infusions every three weeks for the first three to six months, while patients already on immunoglobulin will continue their regular therapy before it is gradually reduced and stopped between months three and six. Rituximab will be given intravenously in a hospital setting. Participants will be followed for two years with about 10 clinic visits for checkups, questionnaires, and blood draws. Researchers will measure remission at 52 weeks, defined by improvement or stable disability without the need for further treatment. Safety and other outcomes like pain, fatigue, quality of life, and adverse events will also be monitored throughout the study period.
CONDITIONS
Brief 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
- Untreated patients (Group 1) or patients on stable maintenance immunoglobulin treatment (Group 2)
- Aged between 18 and 80 years
- Sufficient CIDP-related disability warranting IVIg and rituximab treatment
- Able to provide signed informed consent
- For Group 2, must meet at least one of: wear-off symptoms before next infusion, failed immunoglobulin withdrawal in past year, or recent increased dose leading to improvement
You will not qualify if you...
- Paranodopathy with demonstrated antibodies
- Use of drugs linked to demyelinating neuropathy in last 6 months
- Serious adverse reactions to IVIg or rituximab
- Hypersensitivity to rituximab, immunoglobulins, or excipients
- Known IgA deficiency with antibodies
- Active or untreated hepatitis B or C infection
- Ongoing immunosuppressive treatment except discontinued corticosteroids
- IVIg interval longer than 6 weeks (Group 2 only)
- Obesity with BMI over 35
- Active malignancy or life expectancy under 1 year
- History of recurrent or chronic infections
- Active severe infections like tuberculosis or sepsis
- Severe immunocompromised state
- Severe heart failure or uncontrolled cardiac disease
- Serious other medical conditions
- Pregnancy, nursing, or unwillingness to use contraception
- No signed informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive rituximab infusions at baseline, week 2, and week 26. Group 1 participants also receive intravenous immunoglobulin (IVIg) induction treatment for 3 to 4 months which is stopped after this period. Group 2 participants taper their immunoglobulin treatment starting at week 12 over several weeks.
Hospital visits for rituximab infusions at baseline, week 2, and week 26; additional visits at 2, 8, 13, 26, 39, and 52 weeks
Duration - 52 weeks
Participants are monitored for long-term remission and potential relapse after completing treatment.
Hospital visits at 78 and 104 weeks; unscheduled visits as needed
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands, 1105AZ
Actively Recruiting
Research Team
F
Filip Eftimov, MD PHD
S
Stevie Rozing, MD
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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