Pharmacokinetics of IVIg treatment in patients with CIDP

Rotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous ?-globulin - ROCKY-1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004988-32-NL

Enrollment

Unknown

Registered

2014-01-20

Start date

2014-01-22

Completion date

Unknown

Last updated

2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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. ;Secondary Objective: To investigate which factors influence the pharmacological profile of IVIg, including demographic, clinical and genetic factors.;Primary end point(s): Serum IgG levels determined over the duration of two subsequent IVIg courses at standardized time points, before and after infusion.;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.	—

Measure

Time frame

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. ;Secondary Objective: To investigate which factors influence the pharmacological profile of IVIg, including demographic, clinical and genetic factors.;Primary end point(s): Serum IgG levels determined over the duration of two subsequent IVIg courses at standardized time points, before and after infusion.;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.

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Netherlands

Contacts

Public ContactGBS workgroup Erasmus MC

Erasmus MC

00310107043430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026