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Long-term Safety and Efficacy Study of Adalimumab in Pediatric Su

A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Parrimon, Yozandra; Tilme, Linda

    Trial Phone: 321.841.1361 ; 321.841.5278

  • IRB No: 16.059.05

    Protocol Abbrev: Abbvie M10-870

    Principal Investigator: Jeffrey A. Bornstein, MD

    Sub Investigators: Jackson, Teri ARNP; Mehta, Devendra MD; Raijer, Carolina, ARNP; Safder, Shaista MD; Horvath, Karoly MD; FigueroaColon, Reinaldo MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: Abbvie M10-870

    Treatment: Medication

    Applicable Disease Sites: Ulcerative Colitis

    Therapies Involved: Adalimumab

    ClinicalTrials.gov ID: NCT02632175

  • Objective

    This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

  • Key Eligibility

    Subject must have successfully enrolled and completed M11-290 study