Open-label study of MLN0002 in Ulcerative Colitis & Crohn's Disease

  • Research type

    Research Study

  • Full title

    A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

  • IRAS ID

    7232

  • Contact name

    James Lindsay

  • Eudract number

    2008-002784-14

  • ISRCTN Number

    N/A

  • Research summary

    MLN0002 is a new drug that has been shown to have a positive effect on patients suffering with the inflammatory bowel diseases, Crohn's Disease (CD) and Ulcerative Colitis (UC). Both diseases result in the inflammation of sections of the gastrointestinal tract which gives rise to some unpleasant and painful symptoms including constant diarrhoea, abdominal pain, weight loss and sometimes more severe effects. The symptoms of both diseases come and go but drug therapy is usually required to control the symptoms in the long-term. Current treatments for these diseases have some limitations and it is hoped that MLN0002 will prove to be a more favourable treatment option. Study C13008 is part of a program of studies sponsored by Millennium Pharmaceuticals, Inc. that will review the effectiveness and safety of MLN0002 in a larger group of patients. Study C13008 is the open-label long-term safety and efficacy study that will follow the treatment of both UC and CD patients who have previously been enrolled in a randomised MLN0002 study (C13006 or C13007). It is not known how many patients will enter this study but current estimates suggest approximately 1500 patients will be enrolled. All patients will receive MLN0002 at a dose of 300 mg via an intravenous infusion every 4 weeks for up to 100 weeks. During this time patients will be monitored regularly to record how well they are responding to treatment and to note any side effects associated with the treatment.

  • REC name

    London - South East Research Ethics Committee

  • REC reference

    10/H1102/12

  • Date of REC Opinion

    26 Mar 2010

  • REC opinion

    Further Information Favourable Opinion