Clinical Trial: Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Exte
Brief Summary:
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.
Detailed Summary:
Sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Current Primary Outcome: Efficacy endpoint : Responder rate at end of study (EOS) visit [ Time Frame: 48 weeks after first treatment administration ]
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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Adjusted INCAT disability score [ Time Frame: 48 weeks ]Changes from baseline to 24 weeks (Visit V9) and EOS visit in the adjusted INCAT disability score.
- Responder rate at 24 weeks [ Time Frame: 24 weeks ]
- Time to relapse [ Time Frame: 48 weeks ]
- Grip strength [ Time Frame: 48 weeks ]changes from baseline to 24 weeks (Visit V9) and EOS visit in Grip strength
- Rasch-built Overall Disability Scale (R-ODS) [ Time Frame: 48 weeks ]changes from baseline to 24 weeks (Visit V9) and EOS visit in Rasch-built Overall Disability Scale (R-ODS)
- Medical Research Council (MRC) sum score [ Time Frame: 48 weeks ]changes from baseline to 24 weeks (Visit V9) and EOS visit in Medical Research Council (MRC) sum score
Original Secondary Outcome: Same as current
Information By: Laboratoire français de Fractionnement et de Biotechnologies
Dates:
Date Received: December 11, 2014
Date Started: November 2015
Date Completion: June 2018
Last Updated: September 12, 2016
Last Verified: September 2016