A Multicenter Open-label Study of the Human Anti-Tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease

Trial Profile

A Multicenter Open-label Study of the Human Anti-Tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2016

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors AbbVie
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 20 Jun 2016 Results published in an Eisai media release.
    • 20 Jun 2016 According to an Eisai media release, the company has announced additional approval for a new dosing regimen of Humira pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (adalimumab [recombinant]) in patients with moderate or severe Crohn's disease.
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