RITUXIMAB for Chronic inflammatory demyelinating polyneuropathy (CIDP)

Inclusion criteria

• {"criterion_text":"- 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)\n- Untreated\n- Men and women aged between 18 and 80 years\n- Sufficient CIDP-related disability, as judged by treating physician to warrant IVIg and RTX treatment\n- Capable of giving signed informed consent\n- 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.\n- 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).\n- Men and women aged between 18 and 80 years\n- Capable of giving signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Use of drugs associated with a demyelinating neuropathy in the last six months\n- IVIg interval of once every 6 weeks or more than 6 weeks (applies to Group 2 only)\n- Obesity (BMI > 35)\n- Known active malignancy, (not in remission), currently treated with chemotherapy or immunomodulatory drugs, or with a life expectancy of less than 1 year.\n- History of recurrent/chronic infections\n- Active, severe infections (such as tuberculosis, sepsis and opportunistic infections)\n- Patients in a severely immunocompromised state\n- Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease.\n- Serious co-morbidity as judged by treating physician.\n- 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.\n- No written informed consent\n- 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.\n- Paranodopathy with demonstrated (paranodal) antibodies, previously considered part of CIDP spectrum (in these cases rituximab is preferred treatment)\n- Positive hepatitis B and C serology suggesting active/untreated infection (HBsAg, anti-HB core en anti-HBs and HCV antistof (IgG))\n- Ongoing immunosuppressive treatment for other indications.\n- Immunosuppressive treatment other than (already discontinued) corticosteroids in last 6 months."}

Primary endpoints

• {"endpoint_text":"- Remission at 52 weeks after start of RTX, i.e., no need of additional treatment after RTX treatment.","definition_or_measurement_approach":"Remission defined as no need of additional treatment after RTX at 52 weeks following start of RTX (as stated)."}

Secondary endpoints

• {"endpoint_text":"- Stability on treatment at 104 weeks of follow-up.","definition_or_measurement_approach":"Stability on treatment assessed at 104 weeks of follow-up (no further measurement details provided in JSON)."}

Methods

• K1_Recruitment arrangements document is provided (title present in CTIS documents) — details not extractable from JSON
• K2_Recruitment material: Spierziekten Nederland newsletter (document title indicates recruitment via a patient organisation newsletter)

Netherlands

Earliest CTIS Part Ii Submission Date

03-07-2024

Latest Decision Or Authorization Date

05-03-2026

Processing Time Days

610

Number Of Sites

3

Number Of Participants

102

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands