Last updated on September 2016

Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Male or female patient aged 18 years or more.
    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.
    Covered by national healthcare insurance system as required by local regulations.
    Written informed consent obtained prior to any study-related procedures.

You may not be eligible for this study if the following are true:

  • History of severe allergic reaction or serious adverse reaction to any Ig.
    Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and
    polysorbate 80).
    History of cardiac insufficiency (New York Heart Association (NYHA) III/IV),
    uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled
    hypertension.
    History of venous thromboembolic disease, myocardial infarction or cerebrovascular
    accident.
    Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological
    malignancy with monoclonal gammopathy.
    Body mass index (BMI) ≥40 kg/m².
    Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet
    Renal Disease (MDRD) calculation.
    Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin
    exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer,
    ystemic 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.
    Woman with positive results on a urine pregnancy test or breastfeeding woman or woman
    of childbearing potential without an effective contraception.
    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.
    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.
    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.
    Plasma exchange, blood products or derivatives administered within the last 3 months
    prior to screening.
    Anticipated poor compliance of patient with study procedures.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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