Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers

Trial Profile

Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 31 May 2017

At a glance

  • Drugs Infliximab (Primary)
  • Indications Ankylosing spondylitis; Behcet's syndrome; Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
  • Focus Pharmacokinetics
  • Acronyms REFLECTIONS
  • Sponsors Pfizer
  • Most Recent Events

    • 31 May 2017 According to a Sandoz media release, the European Medicines Agency (EMA) has accepted for regulatory review the Marketing Authorization Application (MAA) for infliximab biosimilar (Remicade). The submission included data from this trial and another phase III trial.
    • 13 Jun 2015 Results of immunogenicity presented at the 16th Annual Congress of the European League Against Rheumatism.
    • 11 Jun 2014 Primary endpoint has been met (Area under the curve from time zero extrapolated to infinite time) according to results presented at the 15th Annual Congress of the European League Against Rheumatism.
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