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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 August 2017
Main ID:  EUCTR2013-005557-73-DE
Date of registration: 08/07/2016
Prospective Registration: Yes
Primary sponsor: LFB BIOTECHNOLOGIES
Public title: An international study on efficacy and safety of I10E in CIDP patients
Scientific title: An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISM
Date of first enrolment: 10/08/2016
Target sample size: 42
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005557-73
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: Single arm If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
France Germany Italy Poland Spain Tunisia Turkey United Kingdom
Contacts
Name: Clinical trial information desk   
Address:  3, avenue des Tropiques, BP 40305 – LES ULIS 91958 COURTABOEUF CEDEX France
Telephone: +33 1 69 82 70 10
Email: neuharte@lfb.fr
Affiliation:  LFB BIOTECHNOLOGIES
Name: Clinical trial information desk   
Address:  3, avenue des Tropiques, BP 40305 – LES ULIS 91958 COURTABOEUF CEDEX France
Telephone: +33 1 69 82 70 10
Email: neuharte@lfb.fr
Affiliation:  LFB BIOTECHNOLOGIES
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male or female patient aged 18 years or more.
2. Definite or probable CIDP according to the European
Federation of Neurological Societies (EFNS)/Peripheral
Nerve Society (PNS) guidelines 2010 clinical and
neurophysiological criteria.
* Pure motor CIDP, provided that a diagnosis of multifocal
motor neuropathy has been ruled out.
* CIDP associated with monoclonal gammopathy of
undetermined significance (MGUS), provided that anti-MAG
antibodies titer is lower than the used technique's negativity
threshold (1000 BTU for Bühlmann ELISA technique).
* Lewis-Sumner syndrome.
3. Score of at least 2 on the adjusted INCAT disability scale.
4. Patient who either :
a)has never been previously treated with Ig (Ig-naïve patient)
OR
b) was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening.
5. Covered by national healthcare insurance system as required by
local regulations.
6. Written informed consent obtained prior to any study-related
procedures.
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 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion criteria:
1. History of severe allergic reaction or serious adverse reaction
to any immunoglobulin (Ig).
2. Clinically documented lack of response to previous Ig
treatment.
3. History of IgA deficiency (IgA = 70 mg/L), unless the absence of anti-IgA antibodies has been documented.
4. Known hypersensitivity to human Ig or to any of the
excipients of I10E (glycine and polysorbate 80).
5. History of cardiac insufficiency (New York Heart
Association [NYHA] III/IV), uncontrolled cardiac
arrhythmia, unstable ischemic heart disease, or uncontrolled
hypertension.
6. History of venous thrombo-embolic disease, myocardial
infarction or, cerebrovascular accident.
7. Risk factor for blood hyperviscosity such as
cryoglobulinemia or haematologic malignancy with
monoclonal gammopathy.
8. History of personal or familial congenital thrombophilia or
acquired thrombophilia.
9. Factors contributing to venous stasis such as long-term bed
confinement.
10. Body Mass Index (BMI) = 40 kg/m².
11. Protein-losing enteropathy characterised by serum protein levels < 60 g/L and serum albumin levels < 30 g/L.
12. History of kidney transplantation, nephrotic syndrome (defined as proteinuria > 3.5 g per 24 hours accompanied by hypoalbuminemia and edema), or any acute or chronic kidney disease that in the opinion of the investigator and/or nephrologist would preclude the use of I10E and/or interfere with the assessment of the safety and efficacy of I10E.
AND/OR
*Chronic kidney disease (CKD) for more than 3 months as documented by at least one of the following:
*glomerular filtration rate (GFR) < 60 mL/min/1.73m2 measured according to the Modified Diet in Renal Disease (MDRD) formula
AND/OR
*urine protein reagent strip: = 2 crosses
AND/OR
*urine protein reagent strip: one cross with one of the following:
*albumin excretion rate (AER) > 300 mg/24 hours or protein excretion rate (PER) > 500 mg/24 hours (24h-urine collection)
OR
*albumin to creatinine ratio (ACR) >30 mg/mmol or protein to creatinine ratio (PCR) > 50 mg/mmol (spot urine sample).
13. Serum levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times upper limit of normal (ULN) range.
14.Any other ongoing disesase that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficienct, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective tissue diseases, infection with HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV), lyme disease, multiple myeloma, Waldenstrom's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
15.Woman with positive results on a urine pregnancy test or breastfeeding women or women of childbearing potential without an effective contraception.
Effective contraceptives are injectable, patch or oral combined oestron progestative or progestative contraceptives, Cooper T or levonorgest releasing intra-uterine devices, depot intramuscular medroxyprogesterone, subcutaneous progestative contraceptive implants, condoms or occlusive caps (diaphragm or cervical/vault caps) with spermicide, true abstinence (when this is in line with the preferred and usual lifestyle of the patient).
16.Any other serious medical condition that would interfere with the clinical assessment of CIDP or use of I10E or prevent the patient from complying with the protocol requirements.
17.Increasing dosage or introduction of a systemic corticoids therapy , or corticosteroids therapy at a dose


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 19.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: IQYMUNE
Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Current Sponsor code: I10
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: The primary objective of this study is to assess the efficacy of I10E in improving the disability of patients with CIDP.

Primary end point(s): Responder rate at EOS visit.
Responders are defined as patients with a decrease =1 point in the
adjusted INCAT score between baseline and the EOS visit.
Secondary Objective: The secondary objective is to assess the safety of I10E in patients with CIDP.
Timepoint(s) of evaluation of this end point: at baseline and the End Of Study visit.
Secondary Outcome(s)
Secondary end point(s): - Responder rate at 12 weeks.
- Time to response.
- Percentage of patients at 12 weeks and EOS visit with no change in
CIDP treatment.
- Changes from baseline to 12 weeks and EOS visit in the following
scores:
• Adjusted INCAT disability score;
• Grip strength with the Martin vigorimeter in both hands;
• Rasch-built Overall Disability Scale (R-ODS);
• Patient and Investigator Clinical Global Impression (CGI);
• Medical Research Council (MRC) 12 muscles sum score (0 to 5) and Rasch-modified MRC (0 to 3).
Timepoint(s) of evaluation of this end point: Baseline, at 12 weeks and End of study visit
Secondary ID(s)
2013-005557-73-GB
I10E-1302
Source(s) of Monetary Support
LFB BIOTECHNOLOGIES
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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