Pharmacokinetics of IVIg treatment in patients with CIDP

• Register: EUCTR
• Last refreshed on: 16 January 2017
• Main ID: EUCTR2013-004988-32-NL
• Date of registration: 20/01/2014
• Prospective Registration: Yes
• Primary sponsor: Erasmus MC
• Public title: Pharmacokinetics of IVIg treatment in patients with CIDP
• Scientific title: Rotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1
• Date of first enrolment: 22/01/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004988-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: NB Observational study: no alterations will be made to patients’ current IVIg treatment regimen. If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands

Contacts

• Name: GBS workgroup Erasmus MC
• Affiliation: Erasmus MC

• Name: GBS workgroup Erasmus MC
• Affiliation: Erasmus MC

Key inclusion & exclusion criteria

Inclusion criteria:
1. Diagnosis of CIDP made by a consultant neurologist, fulfilling the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) clinical diagnostic criteria.
2. EMG findings compatible with the diagnosis CIDP showing peripheral nerve demyelination at least once during their illness. These findings should preferentially fulfill the electrodiagnostic criteria proposed by the European Inflammatory
Neuropathy Cause and Treatment (INCAT) or EFNS/PNS.
3. Age =18 years.
4. Patients require to be on maintenance treatment with IVIg.
5. 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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion criteria:
1. Known IgA deficiency or known allergic reaction to IVIg.
2. 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.
3. Multifocal motor neuropathy (MMN), fulfilling the European Federation of Neurological Societies /Peripheral Nerve Society criteria.
4. IgM paraprotein with anti-myelin-associated glycoprotein (MAG) antibodies.
5. Atypical CIDP with pure sensory or persistent unifocal impairment or significant central nervous system involvement.
6. Severe known abnormalities in liver, kidney function or serum glucose level.
7. Concomitant treatment with prednisone.


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

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyneuropathy

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

Intervention(s)

Trade Name: Kiovig
Product Name: Kiovig
Pharmaceutical Form: Solution for injection/infusion

Primary Outcome(s)

Primary end point(s): Serum IgG levels determined over the duration of two subsequent IVIg courses at standardized time points,
before and after infusion.

Main Objective: The main objective of the study is to determine the PK and PD of IVIg during maintenance treatment in
patients with CIDP. These data will be used to conduct a NONMEM analysis in relation to the dosage,
frequency and batch of IVIg used.

Timepoint(s) of evaluation of this end point: Blood samples will be drawn at multiple time points during two subsequent IVIg courses, including (1) 5 minutes before start of IVIg, treatment, (2) 15 minutes after finishing IVIg treatment, (3) 2 hours after IVIg, (4) 24 hours after, (5) 2 days, (6) 7 days, (7) 14 days and in case of a treatment interval of more than 3 weeks; (8) 21 days after IVIg. Proposed time points are not entirely fixed and the definitive schedule will be in consultation with the patient, to accommodate the sampling times as much as possible to the wishes of the patient. Furthermore, some patients have a treatment interval of 2 weeks or less. Time points will then be adjusted accordingly.

Secondary Objective: To investigate which factors influence the pharmacological profile of IVIg, including demographic, clinical and genetic factors.

Secondary Outcome(s)

Secondary end point(s): Immunological parameters: Serum levels of IgG subclasses, IgG glycoforms, IgG allotypes and genetic polymorphisms involved in IgG metabolism (including polymorphisms in the IgG Fc-receptors). Albumin, cytokines (e.g. type I interferon),
peripheral blood leukocytes and liver function parameters.
Clinical parameters: Clinical factors for disease severity and endpoints, including hand grip strength
(Vigorimeter) and questionnaires (R-ODS en R-FSS).

Timepoint(s) of evaluation of this end point: All immunological parameters will be assessed via the samples collected under the primary end point.
Clinical parameters will be assessed shortly before (hand grip strength) and during the two subsequent IVIg infusions (questionnaires) as well as at 7 and 14 days post IVIg (hand grip strength).

Secondary ID(s)

NL46993.078.13

Source(s) of Monetary Support

Prinses Beatrix Spierfonds