Pilot study with rituximab in patients with CIDP not responding to conventional immune therapy
- Conditions
- Chronic inflammatory demyelinating polyradiculoneuropathyMedDRA version: 20.0Level: LLTClassification code 10072650Term: CIDPSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-001347-31-IT
- Lead Sponsor
- IRCCS ISTITUTO CLINICO HUMANITAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
1. Subject is = 18 years of age at Visit1 (screening) and who signed the informed consent form for the study.
2. Subject has a documented diagnosis of definite or probable CIDP according to the EFNS/PNS criteria 2010 (Joint Task Force of the EFNS and the PNS, 2010).
3. Subject has not improved after and adequate dose of therapy with intravenous immunoglobulins (IVIg) corresponding to at least 2 g/kg monthly for two months, steroids corresponding to the equivalent of at least 1 mg/kg daily of oral prednisone for two months or a course of at least 4 plasma exchanges within two weeks.
4. Subject can take steroids at the maximum dosage equivalent to 12.5 mg/day of prednisone or 25 mg on alternate day or pulsed 400 mg/monthly of methylprednisolone as far as the dosage has been maintained stable (± 20%) in the previous 6 months.
5.Female subjects of childbearing potential according with the Clinical Trial Facilitation Group - CTFG guidelines must have a negative serum pregnancy test and agree to use a highly effective method of birth control in accordance with the CTFG guidelines during the study and for a period of 12 months after their last dose of study drug.
6. Male subject, when sexually active, with a partner of childbearing potential according with the CTFG guidelines must be willing to use a highly effective method of birth control in accordance with the CTFG recommendations during the study and for 12 months after the final administration of rituximab.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1.Subject has a current diagnosis or has a history of Type 1 or Type 2 diabetes mellitus
2.Subject has IgM paraproteinemia with anti-myelin associated glycoprotein antibodies
3.Subject has Multifocal Motor Neuropathy with conduction block (MMN)
4.Clinical or known evidence of associated medical conditions that might cause neuropathy, including but not limited to connective tissue disease, Lyme disease, cancer (with the exclusion of benign skin cancer), Castleman’s disease and systemic lupus erythematosus, malignant plasma cell dyscrasia, lymphoma, osteosclerotic myeloma, POEMS, or assumption of agents that may lead to neuropathy (eg, amiodarone therapy).
5.Female who is pregnant or lactating
6.Subjects with any medical or psychiatric condition (acute or chronic) that, in the opinion of the investigator, could harm the subject or would compromise the subject’s ability to participate in the study.
7.Subjects with congestive heart failure or a moderate or severe impairment of cardiac function
8.Subjects with renal impairment defined as: serum creatinine > 1.4 mg/dL for females and 1.5 mg/dL for males
9.Subjects with an absolute neutrophil count <4000/mm3, lymphocyte count <800/mm3, platelet count <100,000/mm3
10.Subjects with liver impairment defined as total or conjugated bilirubin >1.5 × upper limit of the normal (ULN) range, unless in context of Gilbert’s syndrome; aspartate aminotransferase (AST), alanine aminotransferase (ALT) >3 × ULN range; alkaline phosphatase (AP) >1.5 × ULN range; gamma-glutamyl-transferase (GGT) >3 × ULN range
11.Subjects with a history of clinically relevant ongoing chronic infections including but not limited to human immunodeficiency virus (HIV), hepatitis B, hepatitis C, active or latent tuberculosis or is tested positive for HIV (anti-HIV1 or anti-HIV2 antibodies) hepatitis B (HBsAG positive or HBcAb positive without HBsAb) or hepatitis C (HCV antibodies) at the screening visit.
12.Subject has a family history of primary immunodeficiency
13.Subject has a clinically relevant active infection (eg. sepsis, pneumonia, and abscess) or has had a serious infection (resulting in hospitalization or parenteral antibiotic treatment) within 6 weeks prior to the first dose of rituximab.
14.Subject has an active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix which has been definitely treated with standard of care approaches).
15.Subject was treated with plasma exchange or immunoabsorption within 3 months of randomization, with immunosuppressive/chemotherapeutic medications including azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate within 6 months of randomization, other immunosuppressive medications (including mitoxantrone, alemtuzumab, cladribine, pimecrolimus , IPP-201101) at any time; total lymphoid irradiation or hematopoietic stem cell transplantation at any time; any biological therapy within 12 months of randomization.
16.Subject has received a live vaccination within 8 weeks prior to the baseline visit or intends to have live vaccination during the course of the study or within 7 weeks following the final dose of rituximab.
17.Subject has had prior treatment with rituximab in the 12 months before inclusion
18.Subject is under anticoagulant drugs with the exception of low-dose heparin as preventive therapy
19.History of hy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method