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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 May 2021 |
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Main ID: |
NCT02317562 |
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Date of registration:
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11/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
PRISM2 |
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Scientific title:
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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" |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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19 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02317562 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Italy
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Spain
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Tunisia
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Turkey
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United Kingdom
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Contacts
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Name:
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Eduardo NOBILE-ORAZIO, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS Instituto Clinico Humanitas, Milano, Italy |
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Key inclusion & exclusion criteria
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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-a, interferon-ß1a, 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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Intervention(s)
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Drug: I10E
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Primary Outcome(s)
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Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
[Time Frame: week 48 (End-of-Study)]
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Secondary ID(s)
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I10E-1306
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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