Clinical Trial: Efficacy and Safety Study of I10E in Treatment of Patients With CIDP
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Brief Summary:
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.
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: 24-27 weeks after first treament injection ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Laboratoire français de Fractionnement et de Biotechnologies
Dates:
Date Received: November 13, 2014
Date Started: May 2015
Date Completion: June 2017
Last Updated: September 12, 2016
Last Verified: September 2016