A Proof of Concept Study With Rituximab in Patients With CIDP Not Responding to Conventional Immune Therapy

Exclusion Criteria

• •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 leukocyte 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 one month before inclusion, with immunosuppressive/chemotherapeutic medications including azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate within 6 months before inclusion, 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 before inclusion.
• •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. History of hypersensitivity to Rituximab or to drugs of similar chemical classes