Dose response of IVIg in CIDP.

Completed

Conditions: Chronic inflammatory demyelinating polyradiculoneuopathy is an autoimmune peripheral nerve disorder leading to muscle weakness and sensory dysfunction. keywords: CIDP, IV immunoglobulin

Registration Number: NL-OMON24231

Lead Sponsor: Erasmus MC 's Gravendijkwal 230 Rotterdam3000 CANetherlands

Brief Summary: /A

Detailed Description: Not available

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;

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;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 <br>outcome measures. The secondary objective will be to record the <br>occurrence of side-effects.