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 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Funder | Baxter B.V. (The Netherlands) |
- 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
Scientific
Erasmus Medisch Centrum
Department Neurology
Room H 673
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 408 8209 |
|---|---|
| k.kuitwaard@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, double blinded, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Kiovig, Gammagard |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. The occurrence of side-effects |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
3000 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
