Efficacy and Safety Study of I10E in Treatment of Patients With CIDP (PRISM)
|ClinicalTrials.gov Identifier: NCT02293460|
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : November 28, 2017
To assess the efficacy of I10E in improving the disability of patients with CIDP.
To assess the safety of I10E in patients with CIDP.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyradiculoneuropathy||Drug: I10E||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||September 29, 2017|
|Actual Study Completion Date :||September 29, 2017|
|Experimental: I10E Arm||
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.
- Efficacy endpoint: Responder rate at end of study (EOS) visit [ Time Frame: 24-27 weeks after first treament injection ]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.
- Responder rate at 12 weeks [ Time Frame: 12 weeks ]
- Time to response [ Time Frame: 24-27 weeks ]
- Adjusted INCAT score [ Time Frame: 24-27 weeks ]Changes from baseline to 12 weeks and EOS visit in adjusted INCAT score
- Grip strength [ Time Frame: 24-27 weeks ]Changes from baseline to 12 weeks and EOS visit in Grip strength
- Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: 24-27 weeks ]Changes from baseline to 12 weeks and EOS visit in Rasch-built Overall Disability Scale (R-ODS)
- Medical Research Council (MRC) sum score [ Time Frame: 24-27 weeks ]Changes from baseline to 12 weeks and EOS visit in Medical Research Council (MRC) sum score
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293460
|Principal Investigator:||Eduardo NOBILE-ORAZIO, MD||IRCCS Instituto Clinico Humanitas, Milano, Italy|