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A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Trial Profile

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2024

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Crohn's disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SERENE-CD
  • Sponsors AbbVie; AbbVie Germany

Most Recent Events

  • 01 Sep 2024 Results assessing the exposure-response relationships in induction and maintenance study considering patients baseline characteristics from SERENE ER Analysis Part 1-SERENE CD trial, 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.
  • 02 Feb 2022 Results published in the Gastroenterology

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