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ISRCTN
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ISRCTN52121370
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial comparing two different immunoglobulins in the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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Scientific title
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Acronym
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CIC study
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Serial number at source
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N/A
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Study hypothesis
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Is Kiovig as effective as Gammagard in the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) symptoms?
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Ethics approval
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Ethics approval received from the Medical Ethical Committee of the Erasmus Medical Centre on the 10th October 2007.
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Study design
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Multicentre, randomised, double blinded, active controlled, parallel group trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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Participants - inclusion criteria
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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 Electromyography (EMG) findings compatible with CIDP
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Participants - exclusion criteria
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1. Immunoglobulin A (IgA) deficiency or allergic reactions to Intravenous Immunoglobulin (IVIg)
2. Hereditary neuropathy or severe concomitant illness
3. Multifocal Motor neuropathy (MMn), atypical CIDP
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Anticipated start date
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01/11/2007
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Anticipated end date
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01/10/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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25
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Interventions
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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 double-blind phase, where patients
receive one infusion of Gammagard, followed by four blind gifts (Gammagard or Kiovig).
The second phase is an open-label phase where all patients receive five gifts of Kiovig.
Please note that after medical ethics approva, the start and end dates of this trial have been moved forward. The previous anticipated dates of this trial were:
Anticipated start date: 01/09/2007
Anticipated end date: 01/05/2008
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Primary outcome measure(s)
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1. Efficacy: the Overall Disability Sum Score (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 Medical Research Council (MRC) sum score will be used as secondary outcome scales
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Secondary outcome measure(s)
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1. The occurrence of side-effects
2. The preferences of patients regarding the medication
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Sources of funding
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Baxter B.V. (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
K.
Kuitwaard
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Address
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Erasmus Medisch Centrum
Department Neurology
Room H 673
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Tel
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+31 (0)10 408 8209
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Email
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k.kuitwaard@erasmusmc.nl
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Sponsor
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Erasmus Medical Centre (The Netherlands)
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Address
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Department of Neurology
P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Sponsor website:
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http://www.erasmusmc.nl/content/englishindex.htm
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Date applied
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16/07/2007
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Last edited
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16/10/2007
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Date ISRCTN assigned
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16/07/2007
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