Brief Title
Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
Official Title
International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM Study I10E-1302"
Brief Summary
Primary objective: To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study. (I10E-1302). Secondary objective: To assess the safety of I10E in this patient population.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
Condition
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Intervention
I10E
Study Arms / Comparison Groups
I10E Arm
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
19
Start Date
November 2015
Completion Date
July 28, 2017
Primary Completion Date
July 28, 2017
Eligibility Criteria
Inclusion Criteria: 1. Male or female patient aged 18 years or more. 2. Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease ≥1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study. 3. Covered by national healthcare insurance system as required by local regulations. 4. Written informed consent obtained prior to any study-related procedures. Exclusion Criteria: 1. History of severe allergic reaction or serious adverse reaction to any Ig. 2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80). 3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension. 4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident. 5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy. 6. Body mass index (BMI) ≥40 kg/m². 7. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation. 8. Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective tissue diseases, infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy. 9. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception. 10. Any other serious medical condition that would interfere with the clinical assessment of CIDP or use of I10E or prevent the patient from complying with the protocol requirements. 11. Increasing dosage or introduction of a systemic corticosteroids therapy within the last 3 months prior to screening, at a dose higher than 10 mg daily prednisolone or equivalent. Topical corticosteroids are permitted. 12. Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil and methotrexate) or haemopoetic stem cell transplantation. 13. Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening. 14. Anticipated poor compliance of patient with study procedures.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Eduardo NOBILE-ORAZIO, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02317562
Organization ID
I10E-1306
Responsible Party
Sponsor
Study Sponsor
Laboratoire français de Fractionnement et de Biotechnologies
Study Sponsor
Eduardo NOBILE-ORAZIO, MD, Principal Investigator, IRCCS Instituto Clinico Humanitas, Milano, Italy
Verification Date
April 2021