Last updated on September 2016

Efficacy and Safety Study of I10E in Treatment of Patients With CIDP


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
    Definite or probable CIDP according to the European Federation of Neurological
    Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and
    neurophysiological criteria Pure motor CIDP, provided that a diagnosis of multifocal
    motor neuropathy has been ruled out CIDP associated with monoclonal gammopathy of
    undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower
    than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA
    technique) Lewis-Sumner syndrome
    Score of at least 2 on the adjusted INCAT disability scale
    Patient who either :
    has never been previously treated with Ig (Ig-naive patient) Or
    was previously treated with Ig but is in clinical relapse following treatment
    withdrawal. In the latter case, the last Ig course shall have been administered
    no less than 3 months prior to screening

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

  • History of IgA deficiency, unless the absence of anti-IgA antibodies has been
    documented
    History of cardiac insufficiency (New York Heart Association [NYHA] III/IV),
    uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled
    hypertension
    History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular
    accident
    Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic
    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
    in 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, amyloid, 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 corticotherapy within the last 3 months prior
    to screening, with oral or systemic corticosteroids 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-alfa, interferon-beta1a, anti-CD20, alemtuzumab,
    aziathioprine, etanercept, mycophenolate mofetil, methotrexate and haemopoetic stem
    cell transplantation)
    Plasma exchange, blood products or derivatives administered within the last 3 months
    prior to screening
    Administration of another investigational product within the last month prior to
    creening

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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