Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg (PRNC)

Inclusion Criteria:

• Man or woman between 18 and 80, Weight ≤ 100 kg,

CIDP diagnosis:

• stable or deteriorated state (no spontaneous improvement),
• with the following features:
• motor or sensory and motor deficits, and reduced or abolished tendon reflexes,
• progressive or relapsing evolution,
• global symmetric disability in more than one limb,
• disease course installation over at least 2 months,
• cerebrospinal fluid with ≤10/µL white blood cells and > 0.5 g/L protein rate (non compulsory examination),
• electrophysiological or histological signs of demyelinization,
• INCAT disability score ≥ 2 in arms or ≥ 1 in legs

Exclusion Criteria:

• Severe electrophysiological axonal damage,
• Pure motor syndrome,
• Spontaneous improvement,
• Associated systemic disease that could be the cause of neuropathy,
• Severe cardiac insufficiency,
• Cardiac arrhythmia,
• Severe cardiopulmonary pathology,
• Inflammatory syndrome,
• Severe physical disease which can interfere with the trial,
• Patient in a strict salt-free diet,
• A clinically significant abnormal biological result,
• Positive serology in one of the following tests: HIV1, HIV2, A-B-C hepatitis, Hbs antigen, Lyme disease,
• IgA complete deficiency,
• History of anaphylactic reaction during previous IVIg infusion,
• Hypogammaglobulinemia (IgG < 3g/L),
• Creatinine clearance < 80 mL/min,
• Evolutive gastroduodenal ulcer, diabetes, serious infectious condition, evolutive virus disease (hepatite, herpes, varicella, zona), psychotic states not controlled by treatment, veinous or arterial thrombosis, non controlled high blood pressure, osteoporosis,
• Patient previously treated by corticosteroids, IVIg, plasma exchanges or any other immunosuppressive agent within 3 months before inclusion, except for azathioprine and mycophenolate mofetil which were tolerated in the case of the dose being unmodified within 3 months and kept unchanged during the trial,
• Experienced failure with a IVIG or prednisone prior treatment,
• Hypersensitivity to any components of the 2 treatments,
• Unsigned informed consent,
• Ongoing or planned pregnancy (mandatory pregnancy test at the screening visit), breastfeeding, effective contraception for over 3 months for women of childbearing age.