BridgeMD
Rituximab-induced remission in CIDP (ReCIX study)
EU CTIS ID: 2024-512506-25-00
What this study is testing
The main goal of this study is to assess whether adding RTX to a limited period of IVIg treatment leads to long-term remission and discontinuation of IVIg, reducing the inconvenience of regular Ig infusions and related health care costs
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria Group 1 (new patients): - CIDP according to the EAN/PNS criteria (According to the guideline, symptoms should be developing for at least eight week, mainly to distinguish CIDP from acute polyneuropathy (Guillain Barre syndrome, GBS). However, in some cases, symptoms progress rapidly and lead to severe disability, rendering early treatment necessary. To this end, patients with progressive symptoms for at least four weeks who are strongly suspected of having CIDP may also be included in this trial, provided there are no signs of a different disease (such as GBS or vasculitis neuropathy) - 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 IVIg or SCIg): - CIDP according to the EAN/PNS criteria on maintenance treatment (stable dose/interval of at least 4 infusions or 3 months), including one of the following categories: a) 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 b) patients with a failed withdrawal attempt in the last 12 months captured by at least an MCID on at least one outcome measure c) 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. We will use the most commonly used MCID criteria, namely: 1) one point on the INCAT 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.
You likely can't join if
- Use of drugs associated with a demyelinating neuropathy in the last six 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)
See the full eligibility criteria
Who can join
- Inclusion criteria Group 1 (new patients): - CIDP according to the EAN/PNS criteria (According to the guideline, symptoms should be developing for at least eight week, mainly to distinguish CIDP from acute polyneuropathy (Guillain Barre syndrome, GBS). However, in some cases, symptoms progress rapidly and lead to severe disability, rendering early treatment necessary. To this end, patients with progressive symptoms for at least four weeks who are strongly suspected of having CIDP may also be included in this trial, provided there are no signs of a different disease (such as GBS or vasculitis neuropathy) - 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 IVIg or SCIg): - CIDP according to the EAN/PNS criteria on maintenance treatment (stable dose/interval of at least 4 infusions or 3 months), including one of the following categories: a) 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 b) patients with a failed withdrawal attempt in the last 12 months captured by at least an MCID on at least one outcome measure c) 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. We will use the most commonly used MCID criteria, namely: 1) one point on the INCAT 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.
What rules you out
- Use of drugs associated with a demyelinating neuropathy in the last six 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
- 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.
- Paranodopathy with demonstrated (paranodal) antibodies, previously considered part of CIDP spectrum (in these cases rituximab is preferred treatment)
- Positive hepatitis B and C serology suggesting active/untreated infection (HBsAg, anti-HB core en anti-HBs and HCV antistof (IgG))
- Ongoing immunosuppressive treatment for other indications.
- Immunosuppressive treatment other than (already discontinued) corticosteroids in last 6 months.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.