Dose response study of intravenous immunoglobulin in CIDP

• Register: EUCTR
• Last refreshed on: 7 December 2015
• Main ID: EUCTR2012-005150-34-NL
• Date of registration: 23/07/2014
• Prospective Registration: Yes
• Primary sponsor: Erasmus MC
• Public title: Dose response study of intravenous immunoglobulin in CIDP
• Scientific title: Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy
• Date of first enrolment: 18/11/2014
• Target sample size: 17
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005150-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: comparator is a different dosing schedule of the same drug. placebo is added to maintain the blind o Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands

Contacts

• Name: Krista Kuitwaard
• Affiliation: Erasmus MC

• Name: Krista Kuitwaard
• Affiliation: Erasmus MC

Key inclusion & exclusion criteria

Inclusion criteria:
1.Diagnosis of CIDP or acute-onset CIDP made by a consultant neurologist, fulfilling the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) clinical diagnostic criteria.
2. Age 18 years or older.
3. Significant improvement following the first use of IVIg, defined as a decrease of = 1 grade on the modified Rankin disability scale.
4. To indicate that the patient is still IVIg dependent and has active CIDP, he/she must have shown either an objective deterioration (decrease in muscle strength measured with the vigorimeter and/or MRC sum score following reduction of IVIg dose or lengthening of the IVIg interval or an objective improvement (measured with the vigorimeter and/or MRC sum score) following an increase in IVIg dose or shortening of the IVIg interval at some time during the 9 months before randomisation.
5. Ongoing intermittent treatment with 10% liquid IVIg (Kiovig) for at least 2 infusions. The dose must have been not changed within the 8 weeks prior to the study.
6. EMG findings compatible with CIDP showing peripheral nerve demyelination at least once during their illness.
7. Signed informed consent by the patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
1. Known IgA deficiency or known allergic reaction to IVIg.
2. Hand grip strength measured by the Martin Vigorimeter ? the median value (kPa) for an age and sex matched healthy control.
3. Maintenance dose < 15 gram of IVIg every infusion or an infusion interval < 14 days.
4. Known hereditary neuropathy or severe concomitant diseases such as HIV infection, Lyme disease, chronic active hepatitis, congestive heart failure, systemic lupus erythematosus, drug or toxin induced neuropathy, vasculitis, and malignancies.
5. Multifocal motor neuropathy (MMN), fulfilling the European Federation of Neurological Societies /Peripheral Nerve Society criteria.
6. IgM paraprotein with anti-myelin-associated glycoprotein (MAG) antibodies.
7. Atypical CIDP with pure sensory or persistent unifocal impairment or significant central nervous system involvement.
8. Participation in a controlled trial of an investigational medicinal product within the past 12 weeks.
9. Severe known abnormalities in liver, kidney function or serum glucose level.
10. Treatment with > 20 milligrams of prednisone a day.
11. Treatment with other immunosuppressives (e.g. methotrexate, azathioprine, prednisone) if the dosage has been changed within 8 weeks prior to start of the study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Chronic inflammatory demyelinating polyradiculoneuropathy.
MedDRA version: 18.1 Level: LLT Classification code 10035325 Term: Plasma immunoglobulin G decreased System Organ Class: 100000004848

Intervention(s)

Trade Name: Kiovig
Pharmaceutical Form: Solution for infusion

Primary Outcome(s)

Secondary Objective: The secondary objective is to investigate whether high frequency low dosage of IVIg results in less adverse events compared to low frequency high dosage.

Primary end point(s): Hand grip strength (Vigorimeter) will be used as the primary outcome measure. A difference in the (mean of the 4) Vigorimeter changes from baseline between the two groups of > 8 kPa (mean of both hands) is considered clinically relevant. A difference of > 8 kPa in Vigorimeter change from baseline in favour of the group treated with half the dosage and interval as compared with the other treatment group will be considered a clinical relevant improvement.

Timepoint(s) of evaluation of this end point: Hand grip strenght will be measusured before very infusion, and this endpoint will be evaluated at the end of the trial.

Main Objective: The main objective is to investigate whether high frequency low dosage IVIg treatment is more effective than low frequency high dosage as maintenance treatment for CIDP

Secondary Outcome(s)

Secondary end point(s): Changes in the R-ODSS, R-FSS, and SF-36 will be used as secondary outcome measures. The secondary objective will be to record the occurrence of side-effects.

Timepoint(s) of evaluation of this end point: Questionnaires will be filled-in just before every infusion, and this endpoint will be evaluated at the end of the trial.

Secondary ID(s)

DRIP1.04

Source(s) of Monetary Support

Baxter