A randomised controlled trial comparing two different immunoglobulins in the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

ISRCTN	ISRCTN52121370
DOI	https://doi.org/10.1186/ISRCTN52121370
Secondary identifying numbers	N/A

Submission date: 16/07/2007
Registration date: 16/07/2007
Last edited: 31/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr K. Kuitwaard
Scientific

Erasmus Medisch Centrum
Department Neurology
Room H 673
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 408 8209
Email	k.kuitwaard@erasmusmc.nl

Study information

Study design	Multicentre, randomised, double blinded, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A randomised controlled trial comparing two different immunoglobulins in the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Study acronym	CIC study
Study objectives	Is Kiovig as effective as Gammagard in the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) symptoms?
Ethics approval(s)	Ethics approval received from the Medical Ethical Committee of the Erasmus Medical Centre on the 10th October 2007.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Kiovig, Gammagard
Primary outcome measure	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 study start date	01/11/2007
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	25
Total final enrolment	27
Key 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
Key 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
Date of first enrolment	01/11/2007
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medisch Centrum

Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre

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

Website	http://www.erasmusmc.nl/content/englishindex.htm
"ROR"	https://ror.org/018906e22

Funders

Funder type

Industry

Baxter B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2010	31/12/2020	Yes	No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.