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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: 30 June 2019
Main ID:  EUCTR2013-005558-31-GB
Date of registration: 19/11/2014
Prospective Registration: Yes
Public title: Extension of the international study on efficacy and safety of I10E in CIDP patients
Scientific title: International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM study I10E-1302 - PRISM 2
Date of first enrolment: 08/01/2015
Target sample size: 30
Recruitment status: Not Recruiting
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: no
Placebo: no
Other: no
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 Spain Tunisia Turkey United Kingdom
Name: Clinical trial information desk   
Address:  3, avenue des Tropiques, BP 40305 – LES ULIS 91958 COURTABOEUF CEDEX France
Telephone: +33169 82 70 10
Name: Clinical trial information desk   
Address:  3, avenue des Tropiques, BP 40305 – LES ULIS 91958 COURTABOEUF CEDEX France
Telephone: +33169 82 70 10
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male or female patient aged 18 years or more.
2. Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease =1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
3. Covered by national healthcare insurance system as required
by local regulations.
4. Written informed consent obtained prior to any study-related
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Based on follow-up and results of analyses performed in PRISM
I10E-1302 study, a patient may be eligible in PRISM 2 I10E-1306
study if none of the following criteria is met:
1. History of severe allergic reaction or serious adverse reaction to
any Ig.
2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
6. History of personal or familial congenital thrombophilia or acquired thrombophilia.
7. Factors contributing to venous stasis such as long-term bed confinement.
8. Body mass index (BMI) =40 kg/m².
9. Protein-losing enteropathy characterised by total serum protein levels <60
g/L and serum albumin levels <30 g/L
10. 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.
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
• urine protein reagent strip: =2 crosses
• urine protein reagent strip: one cross with one of the following:
or 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).
11. Serum levels of Alanine aminotransferase (ALT) or Aspartate
aminotransferase (AST) >2 times upper limit of normal range (ULN).
12. Any other ongoing disease that may cause chronic peripheral
neuropathy, such as toxin exposure, dietary deficiency,
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, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
13. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception. Effective contraceptives are injectable, patch or combined oestro-progestative or progestative contraceptives, Copper T or levonorgest releasing intra-uterine devices, depot intramus

Age minimum:
Age maximum:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 20.0 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]

Trade Name: IQYMUNE
Product Name: Human normal 10% immunoglobulin for intravenous administration
Product Code: I10
Pharmaceutical Form: Solution for infusion
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)

Primary end point(s): The primary efficacy endpoint will be the responder rate at EOS
Responders are defined as patients with either:
- No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit.
- An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.
Main Objective: The study is descriptive. The primary objective is to assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study.
Secondary Objective: The secondary objective is to assess the safety of I10E in this patient population.
Timepoint(s) of evaluation of this end point: At the inclusion (baseline), end of study visit
Secondary Outcome(s)

Secondary end point(s): Main secondary efficacy endpoints:
- Change from baseline to 24 weeks (Visit V9) and EOS visit in the adjusted INCAT disability score.
- Responder rate at 24 weeks (visit V9).
- Time to relapse.
- Change from baseline to 24 weeks (Visit V9) and EOS visit in the following scores:
? Grip strength with the Martin Vigorimeter in both hands;
? Rasch-built Overall Disability Scale (R-ODS);
? Medical Research Council (MRC) 12 muscles sum score
(0 to 5) and Rasch-modified MRC (0 to 3).
Other secondary endpoints:
- Percentage of patients at 24 weeks (Visit V9) and EOS visit with no requirement of change in CIDP treatment from baseline.
- Change from baseline to 24 weeks (Visit V9) and EOS visit in Patient and Investigator Clinical Global Impression (CGI).
Timepoint(s) of evaluation of this end point: At the inclusion, at week 24 and at the end of study visit
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Results available:
Date Posted:
Date Completed:
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