Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 21.1 Level: PT Classification code 10064135 Term: Polyneuropathy chronic System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Hizentra
Product Name: Hizentra
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: Human Immunoglobulin G
Other descriptive name: HUMAN IMMUNOGLOBULI
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with typical or pure motor CIDP fulfilling the European Federation of Neurological Societies / Peripheral Nerve Society (EFNS/PNS) clinical and elctrophysiological criteria for definite or propable CIDP Age > 18 and 1 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Previous treatment with immmunoglobulin Pregnancy Malignancies Other causes of neuropathy (Diabetes Mellitus) Severe medical diseases Other immunomodulating treatment in the last 6 weeks prior to inclusion Hepatitis B and C or HIV Lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of SCIG versus IVIG in de-novo CIDP patients during a treatment period of 26 weeks (phase I);Secondary Objective: To evaluate a standardized reduction of dosage regimen to identify the lowest effective dosage of immunoglobulin (phase II).;Primary end point(s): Change in Overall Disability Sum score (ODSS) measured by questionnaire from baseline until end of phase I (26 weeks) Change in Overall Disability Sum score (ODSS) measured by questionnaire from start of phase II and until the lovest effective dosage of immunoglobulin has been reached (up til 60 weeks);Timepoint(s) of evaluation of this end point: Phase I: All patients will be evaluated at baseline (week 0) and re-evaluated at week 2, 4, 14, 20 and 26 Phase II: All patients will be evaluated every 12th week according to lovering of the dosage of immunoglobulin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in parameters describing muscle strength and sensory: o Grip strength, MRC-score, INCAT Sensory Sum Score (ISSS) Change in parameters describing functional ability: o 10-meter-walk test (10-MWT), 6-spot-step test (6-SST), 9-hole-peg test (9-HPT) Change in parameters describing disability, quality of life, pain and treatment satisfaction: QoL (EQ-5D-5L), Fatigue Severity Scale (FSS), Neuropathic Pain Symptom Inventory (NPSI), Rasch built overall disability scale (RODS) and Treatment Satisfaction Questionnaire for Medication (TSQM) Serum samples: Plasma IgG Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count. Fluctuations in describing parameter in each arm at pre-defined time points according to IVIG infusions (pre versus post IVIG): o Week 0, 4 and 20 versus week 2, 14 and 26 ;Timepoint(s) of evaluation of this end point: Phase I: All patients will be evaluated at baseline (week 0) and re-evaluated at week 2, 4, 14, 20 and 26 At week 10 a telephone interview will be done to evaluate treatment response. Phase II: All patients will be evaluated every 12th week according to tappering of the dosage of immunoglobulin | — |
Countries
Denmark
Contacts
Public ContactLars Kjøbsted Markvardsen
Aarhus University Hospital
Outcome results
None listed