Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 (PRISM2)
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|ClinicalTrials.gov Identifier: NCT02317562|
Recruitment Status : Terminated (Sponsor's decision)
First Posted : December 16, 2014
Results First Posted : April 20, 2021
Last Update Posted : April 20, 2021
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).
To assess the safety of I10E in this patient population.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Inflammatory Demyelinating Polyradiculoneuropathy||Drug: I10E||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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"|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||July 28, 2017|
|Actual Study Completion Date :||July 28, 2017|
|Experimental: I10E Arm||
Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.
- Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit [ Time Frame: week 48 (End-of-Study) ]
Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable.
Responders were defined as subjects 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317562
|Principal Investigator:||Eduardo NOBILE-ORAZIO, MD||IRCCS Instituto Clinico Humanitas, Milano, Italy|