To investigate if:-Kiovig is at least as effective as Gammagard. (equivalence)-Kiovig has a good side effect profile for CIDP patients.-Whether patients prefer Kiovig to Gammagard.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The efficacy: the ODSS will be used as the primary outcomescale. A change of
more than one point on the ODSS from baseline will be considered as improvement
or worsening. A change of mean ODSS between the two groups of 1 point or less
will be seen as equivalence. The vigorimeter and the MRC sumscore will be used
as secondary outcome measurements.
Secondary outcome
The secondary objective will be to record the occurence of side-effects and the
preferences of patients regarding the medication.
Background summary
CIDP is a rare nerve disorder leading to a loss of strength and sensibility.
Intravenous immuunglobulins are proven to be effective in the treatment of
CIDP. In practise CIDP patients are treated with different brands of
immunoglobulins, (depending on what is available) that are considered to have
comparable efficacy, although this has not been formally investigated. In
practise CIDP patients often report that some IVIg brands are more effective
than others. Kiovig is a registered immuunglobuline brand which is easy to
administer and can be infused faster than other immunoglobulines. A shorter
infusion time is preferable because most CIDP patients need long term
treatment.
Study objective
To investigate if:
-Kiovig is at least as effective as Gammagard. (equivalence)
-Kiovig has a good side effect profile for CIDP patients.
-Whether patients prefer Kiovig to Gammagard.
Study design
Patients are given Kiovig instead of Gammagard, the dose and dose-interval will
be the same. Neurological examination, squeeze strength and questionnaires are
used to show if Kiovig is as effective as Gammagard. Side-effects and patient
preference are recorded. The first part of the study is a randomized
dubbel-blind study, where patients receive either Gammagard or Kiovig. The
second part of the study is an open-label phase where all patients receive
Kiovig treatment.
Intervention
The first group will receive a brand of immunoglobulin; Gammagard. The
individual dosage and dosage-interval will be used.
the second group will receive another brand of immunoglobulin; kiovig.
Again the dosage and dosage-interval will be kept the same.
Study burden and risks
Because Kiovig is a registered immunoglobuline the side-effects will be similar
as Gammagard. The patients burden is small, six Neurological examinations and
the completion of some simple questionnaires.
's gravendijkwal 230
3000 CA rotterdam
Nederland
's gravendijkwal 230
3000 CA rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
minimum age of 18 years, improvement of muscle function after start Gammagard, active illness, ongoing intermittent treatment with a stable Gammagard dose. clinical and EMG findings compatible with CIDP
Exclusion criteria
IgA deficiency or allergic reactions to IVIg. Hereditary neuropathy or severe concomittant illness. MMN. atypical CIDP.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001777-29-NL |
| ISRCTN | ISRCTN52121370 |
| CCMO | NL16730.078.07 |