Is Kiovig as effective as Gammagard in the treatment of CIDP symptoms
ID
Bron
Verkorte titel
Aandoening
immunoglobulin
CIDP
Polyneuropathy
treatment
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
In practise CIDP patients are treated with different brands of immunoglobulins that are considered to hace comparable efficacy, although this has not been formally investigated. Kiovig is a registered immunoglobulin which is easy to administer and can be infused faster. the first fase is a randomised double blind where patients receive either Kiovig or Gammagard. Neurological examination, muscle grip strenght and questionnaires are used to show if kiovig is as effective as Gammagard. the second fase is an open label fase where all the patients receive Kiovig
Doel van het onderzoek
Is Kiovig as effective as Gammagard in the treatment of CIDP symptoms
Onderzoeksproduct en/of interventie
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 patients
receive 1 infuse Gammagard, followed by 4 blind gifts (Gammagard or Kiovig) The second phase ia an open-label
phase where all patients recieve 5 gifts Kiovig.
Publiek
department Neurology, room H 673,
K. Kuitwaard
's gravendijkwal 230
Rotterdam 3000 CA
The Netherlands
+31 10-4088209
k.kuitwaard@erasmusmc.nl
Wetenschappelijk
department Neurology, room H 673,
K. Kuitwaard
's gravendijkwal 230
Rotterdam 3000 CA
The Netherlands
+31 10-4088209
k.kuitwaard@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. IgA deficiency or allergic reactions to IVIg;
2. Hereditary neuropathy or severe concomittant illness;
3. MMn. atypical CIDP.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL965 |
| NTR-old | NTR992 |
| Ander register | : |
| ISRCTN | ISRCTN52121370 |