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 ]

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.


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