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Kiovig as a treatment in CIDP

Kiovig as a treatment in chronic inflammatory demyalinating polyneuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24420
Enrollment
25
Registered
2007-06-05
Start date
2007-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immunoglobulin CIDP Polyneuropathy treatment

Interventions

The investigational product is Kiovig a brand of immunoglobulin. Kiovig will be compared to Gammagard (another brand of immunoglobulin). The first phase is a randomised dubbel-blind phase, where pati

Sponsors

Prof. P.A. van doorn
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Minimum age 18 years; 2. Improvement of muscle function after start Gammagard; 3. Active illness; 4. Ongoing intermittent treatment with a stable Gammagard dose; 5. Clinical and EMG findings compatible with CIDP

Exclusion criteria

Exclusion criteria: 1. IgA deficiency or allergic reactions to IVIg; 2. Hereditary neuropathy or severe concomittant illness; 3. MMn. atypical CIDP.

Design outcomes

Primary

MeasureTime frame
1. The efficacy. The ODSS will be used as the primary outcome scale. A change of more than one point will be considered as improvement or worsening. 2. The vigorimeter and MRC sumscore will be used as secondary outcome scales.

Secondary

MeasureTime frame
1. The secondary objective will be to record the occurence of side-effects; 2. The preferences of patients regarding the medication.

Contacts

Public ContactK. Kuitwaard

Erasmus MC, department Neurology, room H 673,

k.kuitwaard@erasmusmc.nl+31 10-4088209

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)