Extension of the international study on efficacy and safety of I10E in CIDP patients
- Conditions
- 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 disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-005558-31-GB
- Lead Sponsor
- FB BIOTECHNOLOGIES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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.
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:
or albumin excretion rate (AER) >300 mg/24 hours
or protein excretion rate (PER) >500 mg/24 hours (24h-urine collection)
OR
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> Primary end point(s): The primary efficacy endpoint will be the responder rate at EOS<br> visit.<br> Responders are defined as patients with either:<br> - No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit.<br> or<br> - An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.<br> ;Timepoint(s) of evaluation of this end point: At the inclusion (baseline), end of study visit
- Secondary Outcome Measures
Name Time Method