(duplicate) M10-870 Adalimumab in Paediatric Ulcerative Colitis (Ext)

• Research type

  Research Study

• Full title

  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 (protocol M10-870)

• IRAS ID

  202213

• Contact name

  Daniel Kreeb

• Contact email

  daniel.kreeb@abbvie.com

• Sponsor organisation

  Abbvie Deutschland GmbH & Co. KG

• Eudract number

  2015-001346-29

• Clinicaltrials.gov Identifier

  NCT02632175

• Duration of Study in the UK

  5 years, 7 months, 1 days

• Research summary

  Study M10-870 – A Multi-centre open-label study of the human anti-TNF monoclonal antibody Adalimumab to evaluate long-term safety and tolerability of repeated administration of Adalimumab in paediatric subjects with ulcerative colitis (UC), who completed the study M11-290.
  Study M10-870 is an extension study of the main M11-290 study of adalimumab, which was designed to study the effectiveness and safety of adalimumab in children aged 4-17 with UC. M11-290 study targets subjects who have failed therapy with corticosteroids and/or immunosuppressants and treatment lasts for approximately 52 weeks. The M10-870 study follows on directly from the last study visit for M11-290; the Week 52 visit from the Study M11-290 will serve as the Baseline Visit for subjects entering Study M10-870.
  Study M10-870 allows the further evaluation of adalimumab treatment with respect to long-term safety, tolerability and maintenance of clinical response, and allows continuity of treatment from the M11-290 study.
  Approximately 70 sites worldwide, who have enrolled subjects into Study M11-290, will participate in the Study M10-870 clinical trial. Approximately 85 subjects from the M11-290 study are expected to enrol.
  Subjects in M10-870 will receive treatment with open-label adalimumab for 96 weeks. Subjects will provide daily diary data regarding their UC, and may undergo up to two endoscopies in the study. Research procedures to evaluate safety, include blood tests and physical exams.
  This study is important because medically there is a need for new medications for children with UC. They usually have more extensive and more severe disease than adults with higher rates of resultant surgery yet the range of approved medications for use in children remains limited. There remains a significant therapeutic gap in paediatric UC where children do not respond or lose response to or do not tolerate the available medications.
  This study is funded by AbbVie Deutschland GmbH & Co. KG

• REC name

  West of Scotland REC 1

• REC reference

  16/WS/0077

• Date of REC Opinion

  27 Apr 2016

• REC opinion

  Further Information Favourable Opinion