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A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis

Trial Profile

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2024

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SERENE-UC
  • Sponsors AbbVie; AbbVie Germany

Most Recent Events

  • 01 Sep 2024 Results assessing exposure-response (ER) relationships in induction and maintenance studies considering patients' baseline characteristics, disease characteristics, and prior treatments, using an established adalimumab population pharmacokinetics (popPK) model, published in the Clinical Pharmacology in Drug Development.
  • 11 Mar 2023 Results assessing the impact of immunogenicity and improving prediction of trough concentrations of Adalimumab in patients with Crohns Disease and Ulcerative Colitis from SERENE CD (NCT02065570) and SERENE UC (NCT02065622) studies, published in the Clinical Pharmacokinetics..
  • 25 Feb 2022 Results published in the Gastroenterology

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