Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 17

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hand grip strength (Vigorimeter) will be used as the primary outcome<br /><br>measure. A difference in the (mean of the 4) Vigorimeter changes from<br /><br>baseline between the two groups of > 8 kPa (mean of both hands) is<br /><br>considered clinically relevant. A difference of > 8 kPa in Vigorimeter<br /><br>change from baseline in favour of the group treated with half the dosage<br /><br>and interval as compared with the other treatment group will be<br /><br>considered a clinical relevant improvement.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in the R-ODSS, R-FSS, and SF-36 will be used as secondary<br /><br>outcome measures. The secondary objective will be to record the<br /><br>occurrence of side-effects.</p><br>