|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR992 |
|
Date of registration:
|
05/06/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Kiovig as a treatment in CIDP
|
|
Scientific title:
|
Kiovig as a treatment in chronic inflammatory demyalinating polyneuropathy - KIC study |
|
Date of first enrolment:
|
1/7/2007 |
|
Target sample size:
|
25 |
|
Recruitment status: |
complete |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=992 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: -
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
P.A.
Doorn, van |
|
Address:
|
Erasmus MC
Department Neurology
's gravendijkwal 230
3000 CA
Rotterdam
The Netherlands |
|
Telephone:
|
+31 10-4633780 |
|
Email:
|
p.a.vandoorn@erasmusmc.nl |
|
Affiliation:
|
|
|
|
Name:
|
K.
Kuitwaard |
|
Address:
|
Erasmus MC,
department Neurology, room H 673,, 's gravendijkwal 230
3000 CA
Rotterdam
The Netherlands |
|
Telephone:
|
+31 10-4088209 |
|
Email:
|
k.kuitwaard@erasmusmc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion 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: 1. IgA deficiency or allergic reactions to IVIg;
2. Hereditary neuropathy or severe concomittant illness;
3. MMn. atypical CIDP.
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD), Immunoglobulin, Polyneuropathy
|
|
Intervention(s)
|
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.
|
|
Primary Outcome(s)
|
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 Outcome(s)
|
1. The secondary objective will be to record the occurence of side-effects;
2. The preferences of patients regarding the medication.
|
|
Secondary ID(s)
|
|
ISRCTN52121370
|
|
Source(s) of Monetary Support
|
|
Baxter
|
|