A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Trial Profile

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2017

At a glance

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

    • 08 Nov 2017 Results (n=295) of extension phase of the study in patients who have completed the main 48 week study, presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting.
    • 08 Nov 2017 Results of a post-hoc analysis assessing the impact of BMI on clinical response (n=332) presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 05 Nov 2017 According to a Celltrion media release, A total of 295 patients participated in the extension period after completing treatment up to 48 weeks with CT-P10 or reference rituximab.
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