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Report for Clinical Trial NCT02317562

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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
MeSH:Polyradiculoneuro Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

1 Interventions

Name: I10E

Description: Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.
Type: Drug
Group Labels: 1

I10E Arm


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 administration

Secondary 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 weeks

Measure: 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 weeks

Description: 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 weeks

Description: 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

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes