SNPMiner Trials (Home Page)
Report for Mutation I10E
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 3 clinical trials
Clinical Trials
1 A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor Neuropathy
The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.
NCT01951924 Motor Neuron Disease Drug: Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL) Drug: Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL) MeSH:Motor Neuron Disease Amyotrophic Lateral Sclerosis
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis
A European, Randomised, Double-blind, Active Comparator Controlled, Cross-over, Efficacy and Safety Study of a New 10% Ready To-use Liquid Human Intravenous Immunoglobulin (I10E) Versus Kiovig® in Patients With Multifocal Motor Neuropathy. --- I10E ---
LIME Study (LFB IVIg MMN Efficacy Study) The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of MMN in a randomized, double-blind, active comparator-controlled, cross-over trial. --- I10E ---
Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008. --- I10E ---
Change between I10E and Kiovig® in: MMRC 10 new sum score (10 slightly different muscles on both sides). --- I10E ---
Change between I10E and Kiovig® in : Rasch built MMRC sum score (Cats 2008). --- I10E ---
Change between I10E and Kiovig® in : INCAT: upper and lower limbs. --- I10E ---
Change between I10E and Kiovig®: Grip strength. --- I10E ---
Change between I10E and Kiovig® in: MMRC 14 sum score. --- I10E ---
5. Known hypersensitivity to the active substance or to any of the excipients of I10E (glycine and polysorbate 80) or Kiovig(glycine). --- I10E ---
Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient from complying with the protocol requirements. --- I10E ---
Other parameters of muscle strength such as measurement of grip strength by dynamometer - and functional disability will also be evaluated to reinforce the robustness of the study and substantiate the efficacy of I10E in MMN patients. --- I10E ---
Primary Outcomes
Measure: Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008 Time: at 6 months and 1 yearSecondary Outcomes
Measure: Change between I10E and Kiovig® in: MMRC 10 new sum score (10 slightly different muscles on both sides) Time: at 6 months and 1 yearMeasure: AEs observed and reported TAAEs (temporally associated AE) beginning at infusion or within 72H after infusion Time: from 49 to 56 weeks
Measure: Change between I10E and Kiovig® in : Rasch built MMRC sum score (Cats 2008) Time: at 6 months and 1 year
Measure: Change between I10E and Kiovig® in : INCAT: upper and lower limbs Time: at 6 months and 1 year
Measure: Change between I10E and Kiovig®: Grip strength Time: at 6 months and 1 year
Measure: Change between I10E and Kiovig® in: MMRC 14 sum score Time: at 6 months and 1 year
2 An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.
NCT02293460 Chronic Inflammatory Demyelinating Polyradiculoneuropathy Drug: I10E MeSH:Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.. Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. --- I10E ---
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.. Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. --- I10E --- --- I10E ---
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.. Efficacy and Safety Study of I10E in Treatment of Patients With CIDP Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. --- I10E --- --- I10E --- --- I10E ---
Secondary objective: To assess the safety of I10E in patients with CIDP. --- I10E ---
9. 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 10. --- I10E ---
Primary Outcomes
Description: Responders were defined as patients with a decrease ≥1 point in the adjusted INCAT disability score compared to baseline. Adjusted INCAT disability score can vary from 0 (normal) to 9 (maximal disability). If a patient was treated with a not-allowed treatment during the study period, then all adjusted INCAT disability score measured after the intake of these not-allowed treatments were censored. If the score at EoS visit was missing, then the Last Observation Carried Forward (LOCF) approach was applied to replace this missing value.
Measure: Efficacy Endpoint: Responder Rate at End of Study Time: 24 weeks after first treament injection3 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"
Primary objective: 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. (I10E-1302). Secondary objective: To assess the safety of I10E in this patient population.
NCT02317562 Chronic Inflammatory Demyelinating Polyradiculoneuropathy Drug: I10E MeSH:Polyradiculoneuro Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
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". --- I10E ---
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". --- I10E --- --- I10E ---
Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 Primary objective: 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. --- I10E ---
Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 Primary objective: 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. --- I10E --- --- I10E ---
Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 Primary objective: 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. --- I10E --- --- I10E --- --- I10E ---
(I10E-1302). --- I10E ---
Secondary objective: To assess the safety of I10E in this patient population. --- I10E ---
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. --- I10E ---
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. --- I10E --- --- I10E ---
Exclusion Criteria: 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. --- I10E ---
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. --- I10E ---
Primary Outcomes
Description: 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.
Measure: Efficacy endpoint : Responder rate at end of study (EOS) visit Time: 48 weeks after first treatment administrationSecondary Outcomes
Description: Changes from baseline to 24 weeks (Visit V9) and EOS visit in the adjusted INCAT disability score.
Measure: Adjusted INCAT disability score Time: 48 weeksMeasure: Responder rate at 24 weeks Time: 24 weeks
Measure: Time to relapse Time: 48 weeks
Description: changes from baseline to 24 weeks (Visit V9) and EOS visit in Grip strength
Measure: Grip strength Time: 48 weeksDescription: changes from baseline to 24 weeks (Visit V9) and EOS visit in Rasch-built Overall Disability Scale (R-ODS)
Measure: Rasch-built Overall Disability Scale (R-ODS) Time: 48 weeksDescription: changes from baseline to 24 weeks (Visit V9) and EOS visit in Medical Research Council (MRC) sum score
Measure: Medical Research Council (MRC) sum score Time: 48 weeks