SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02293460

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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
MeSH:Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

1 Interventions

Name: I10E

Description: Patients who meet all eligibility criteria will receive one dose of IMP at 2g/kg over 2-5 days followed by 7 doses of IMP at 1g/kg over 1-2 day(s), every 3 weeks. Duration of treatment period: 21 weeks +/- 7 days.
Type: Drug
Group Labels: 1

I10E Arm


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 injection

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes