Adalimumab in Pediatric Subjects With Moderate to Severe UC

The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Parrimon, Yozandra; Tilme, Linda

    Trial Phone: 321.841.1361 ; 321.843.5278

  • IRB No: 14.030.02

    Protocol Abbrev: ABBVIE M11-290

    Principal Investigator: Jeffrey A. Bornstein, MD

    Sub Investigators: FigueroaColon, Reinaldo MD; Horvath, Karoly MD; Mehta, Devendra MD; Safder, Shaista MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: M11-290

    Treatment: Interventional study drug

    Applicable Disease Sites: GI

    Therapies Involved: Adalimumab Subcutaneous (SC) injection or Placebo

    ClinicalTrials.gov ID: NCT02065557

  • Objective

    The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

  • Key Eligibility

    Male or Female, 4 Years to 17 Years; Diagnosis of Ulcerative Colitis (UC) for at least 12 weeks prior to screening; Active ulcerative colitis despite concurrent treatment with oral corticosteroids, immunosuppressants or both