Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy - Dose Response of IVIg in CIDP (DRIP-study)

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 17 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•1.Diagnosis of CIDP or acute-onset CIDP made by a consultant neurologist, fulfilling the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) clinical diagnostic criteria. ;2. Age 18 years or older. ;3. Significant improvement following the first use of IVIg, defined as a decrease of * 1 grade on the modified Rankin disability scale. ;4. To indicate that the patient is still IVIg dependent and has active CIDP, he/she must have shown either an objective deterioration (decrease in muscle strength measured with the vigorimeter and/or MRC sum score) following reduction of IVIg dose or lengthening of the IVIg interval or an objective improvement (measured with the vigorimeter and/or MRC sum score) following an increase in IVIg dose or shortening of the IVIg interval at some time during the 9 months before randomisation. ;5. Ongoing intermittent treatment with 10% liquid IVIg (Kiovig) for at least 2 infusions. The dose must have been not changed within the 8 weeks prior to the study.;6. EMG findings compatible with CIDP showing peripheral nerve demyelination at least once during their illness.;7. Signed informed consent by the patient.

•1. Known IgA deficiency or known allergic reaction to IVIg.;2. Hand grip strength measured by the Martin Vigorimeter equal or more than the median value (kPa) for an age and sex matched healthy control.;3. Maintenance dose less than 15 gram of IVIg every infusion or an infusion interval less than 14 days.;4. Known hereditary neuropathy or severe concomitant diseases such as HIV infection, Lyme disease, chronic active hepatitis, congestive heart failure, systemic lupus erythematosus, drug or toxin induced neuropathy, vasculitis, and malignancies. ;5. Multifocal motor neuropathy (MMN), fulfilling the European Federation of Neurological Societies /Peripheral Nerve Society criteria. ;6. IgM paraprotein with anti-myelin-associated glycoprotein (MAG) antibodies. ;7. Atypical CIDP with pure sensory or persistent unifocal impairment or significant central nervous system involvement.;8. Participation in a controlled trial of an investigational medicinal product within the past 12 weeks. ;9. Severe known abnormalities in liver, kidney function or serum glucose level.;10. Treatment with more than 20 milligrams of prednisone a day.;11. Treatment with other immunosuppressives (e.g. methotrexate, azathioprine, prednisone) if the dosage has been changed within 8 weeks prior to start of the study.

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