Clinical Trial: Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple Sclerosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: International Multi-center Double-blind Comparative Randomized Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 (JSC "BIOCAD", Russia) 120 mcg or 180 mcg Intramuscularly,

Brief Summary: International multi-center double-blind comparative randomized clinical trial to evaluate efficacy, safety and tolerance of BCD-054 (JSC "BIOCAD", Russia) 120 mcg or 180 mcg intramuscularly, biweekly and Avonex® (Biogen Idec Limited, Great Britain) 30 mcg, weekly, for treatment of patients with remitting multiple sclerosis

Detailed Summary:
Sponsor: Biocad

Current Primary Outcome: Average annual rate of exacerbations [ Time Frame: Week 52, Week 104 ]

Average annual rate of exacerbations is calculated based on the number of confirmed relapses per year during BCD-054 / Avonex® therapy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients without relapse [ Time Frame: Week 52, Week 104 ]
  • Time before first relapse and risk of relapse [ Time Frame: 52 weeks ]
  • CUA [ Time Frame: Week 52, Week 104 ]
    CUA (combined unique active) - the cumulative number of new accumulating contrast lesions on MRI in T1 mode, and new lesions in T2-weighted or any increase in foci in T2 mode
  • Frequency of AE/SAE [ Time Frame: 104 weeks ]
  • Proportion of patients who develop binding and neutralizing antibodies to study drug [ Time Frame: 104 weeks ]
  • AUC (0-168 hours) [ Time Frame: 0 to 168 hours after 1 study drug injection ]
    AUC (0-168 hours) - area under curve "concentration - time" from 0 to 168 hours
  • AUC (0-336 hours) [ Time Frame: from 0 to 336 hours after 1 study drug injection ]
    AUC (0-336 hours) - area under curve "concentration - time" from 0 to 336 hours
  • AUEC (0-168 hours) [ Time Frame: from 0 to 168 hours after 1 study drug injection ]
    AUEC (0-168 hours) - area under effect curve "concentration of MxA-protein/neopterin - time" from 0 to 168 hours
  • AUEC (0-336 hours) [ Time Frame: from 0 to 336 hours after 1 study drug injection ]
    AUEC (0-336 hours) - area under effect curve "concentration of MxA-protein/neopterin - time" from 0 to 336 hours
  • AUCss (0-168 hours, 0-336 hours) [ Time Frame: from 0 to 168 hours and from 0 to 336 hours after injection 29 ]
    AUCss (0-168 hours, 0-336 hours) - area under curve "concentration - time" from 0 to 168 hours and from 0 to 336 hours(after injection №29, in steady state conditions)
  • AUECss (0-168 hours, 0-336 hours) [ Time Frame: from 0 to 168 hours and from 0 to 336 hours after injection 29 ]
    AUECss (0-168 hours, 0-336 hours) - area under effect curve "concentration of MxA-protein/neopterin - time" from 0 to 168 hours and from 0 to 336 hours (after injection №29, in steady state conditions)


Original Secondary Outcome: Same as current

Information By: Biocad

Dates:
Date Received: April 3, 2016
Date Started: August 2016
Date Completion: August 2017
Last Updated: April 15, 2016
Last Verified: April 2016