Condition category
Nervous System Diseases
Date applied
16/07/2007
Date assigned
16/07/2007
Last edited
16/10/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K. Kuitwaard

ORCID ID

Contact details

Erasmus Medisch Centrum
Department Neurology
Room H 673
Rotterdam
3000 CA
Netherlands
+31 (0)10 408 8209
k.kuitwaard@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

CIC study

Study hypothesis

Is Kiovig as effective as Gammagard in the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) symptoms?

Ethics approval

Ethics approval received from the Medical Ethical Committee of the Erasmus Medical Centre on the 10th October 2007.

Study design

Multicentre, randomised, double blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Kiovig, Gammagard

Primary outcome measures

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

Secondary outcome measures

1. The occurrence of side-effects
2. The preferences of patients regarding the medication

Overall trial start date

01/11/2007

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant 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 Electromyography (EMG) findings compatible with CIDP

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

25

Participant exclusion criteria

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

Recruitment start date

01/11/2007

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medisch Centrum
Rotterdam
3000 CA
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Neurology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Industry

Funder name

Baxter B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes