Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy

Erasmus MC0 个研究点目标入组 17 人开始时间: 2014年7月23日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. Known IgA deficiency or known allergic reaction to IVIg.
•2. Hand grip strength measured by the Martin Vigorimeter ? the median value (kPa) for an age and sex matched healthy control.
•3. Maintenance dose < 15 gram of IVIg every infusion or an infusion interval < 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 > 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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