SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02293460

Developed by Shray Alag, 2019.
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

I10E Arm


Primary Outcomes

Description: Responder rate at EOS visit. Responders are defined as patients with a decrease >=1 point in the adjusted INCAT score between baseline and the EOS visit.

Measure: Efficacy endpoint: Responder rate at end of study (EOS) visit

Time: 24-27 weeks after first treament injection

Secondary Outcomes

Measure: Responder rate at 12 weeks

Time: 12 weeks

Measure: Time to response

Time: 24-27 weeks

Description: Changes from baseline to 12 weeks and EOS visit in adjusted INCAT score

Measure: Adjusted INCAT score

Time: 24-27 weeks

Description: Changes from baseline to 12 weeks and EOS visit in Grip strength

Measure: Grip strength

Time: 24-27 weeks

Description: Changes from baseline to 12 weeks and EOS visit in Rasch-built Overall Disability Scale (R-ODS)

Measure: Rasch-built Overall Disability Scale (R-ODS)

Time: 24-27 weeks

Description: Changes from baseline to 12 weeks and EOS visit in Medical Research Council (MRC) sum score

Measure: Medical Research Council (MRC) sum score

Time: 24-27 weeks

Purpose: Treatment

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