Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis.

Trial Profile

Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis.

Completed
Phase of Trial: Phase I

Latest Information Update: 14 Nov 2016

At a glance

  • Drugs Rituximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Pharmacokinetics; Registrational
  • Acronyms Triad RA
  • Sponsors Celltrion
  • Most Recent Events

    • 14 Nov 2016 According to a Celltrion media release, data of phase I 72-week extension study and an additional 1 year switching study were presented in ACR 2015 and EULAR 2016.
    • 13 Sep 2016 Results assessing pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety published in the Annals of the Rheumatic Diseases.
    • 07 May 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.
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