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
Conditions
Interventions
Trade Name: IQYMUNE
Product Name: Human normal 10% immunoglobulin for intravenous administration
Product Code: I10
Pharmaceutical Form: Solution for in
Sponsors
LFB BIOTECHNOLOGIES
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; Primary end point(s): The primary efficacy endpoint will be the responder rate at EOS visit. 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. or - An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit. ;Timepoint(s) of evaluation of this end point: At the inclusion (baseline), end of study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At the inclusion, at week 24 and at the end of study visit; 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). | — |
Countries
France, Germany, Italy, Spain, Tunisia, Turkey, United Kingdom
Contacts
Public ContactClinical trial information desk
LFB BIOTECHNOLOGIES
Outcome results
None listed