Chronic inflammatory demyelinating polyradiculoneuopathy is an autoimmune peripheral nerve disorder leading to muscle weakness and sensory dysfunction. keywords: CIDP, IV immunoglobulin
Conditions
Interventions
Intervention group/arm:
4 infusions of IVIg of half the normal dosage (with placebo added to maintain the total volume) and half the interval (double the frequency).
Control group/arm:
2 infusion
dose and interval as well as two sham (placebo) infusions.
The total amount of IVIg given during the whole double-blind phase will remain the same in both groups. As this is a crossover study all pa
Sponsors
Erasmus MC
's Gravendijkwal 230
Rotterdam
3000 CA
Netherlands
Eligibility
Inclusion criteria
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 an objective deterioration (decrease in muscle strength measured with the vigorimeter and/or MRC sum score) following reduction of IVIg dose at some time during the 9 months before randomization or an objective improvement following an increase in IVIg during the 9 months before randomization; 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hand grip strength (Vigorimeter) will be used as the primary outcome measure. A difference in the (mean of the 4) Vigorimeter changes from baseline between the two groups of > 8 kPa (mean of both hands) is considered clinically relevant. A difference of > 8 kPa in Vigorimeter change from baseline in favour of the group treated with half the dosage and interval as compared with the other treatment group will be considered a clinical relevant improvement. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Rasch-built overall disability scale (R-ODS) measuring activity status, Rasch fatigue severity scale (R-FSS) measuring fatigue, and quality of life (SF-36) will be used as secondary outcome measures. The secondary objective will be to record the occurrence of side-effects. | — |
Contacts
Public ContactKrista Kuitwaard
Department of Neurology Erasmus MC 's Gravendijkwal 230
Outcome results
None listed