A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera in Subjects with Severe Rheumatoid Arthritis (RA) [Randomizovane, dvojite zaslepene, multicentricke hodnoceni s paralelnimi skupinami, porovnavajici ucinnost, bezpecnost, farmakodynamiku a farmakokinetiku pripravku SAIT101 s pripravkem MabThera u pacientu s aktivni formou revmatoidni artritidy (RA)]

Trial Profile

A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera in Subjects with Severe Rheumatoid Arthritis (RA) [Randomizovane, dvojite zaslepene, multicentricke hodnoceni s paralelnimi skupinami, porovnavajici ucinnost, bezpecnost, farmakodynamiku a farmakokinetiku pripravku SAIT101 s pripravkem MabThera u pacientu s aktivni formou revmatoidni artritidy (RA)]

Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 May 2014

At a glance

  • Drugs Rituximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Pharmacokinetics; Therapeutic Use
  • Sponsors Samsung
  • Most Recent Events

    • 20 Jul 2012 New source identified and integrated (United Kingdom Clinical Research Network, 12090).
    • 10 Mar 2012 Planned number of patients changed from 120 to 616 as reported by European Clinical Trials Database record.
    • 10 Mar 2012 Planned end date 15 May 2015 added as reported by European Clinical Trials Database record.
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