Phase 3b Ulcerative Colitis Study in Usual Clinical Practice

• Research type

  Research Study

• Full title

  An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilisation and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting

• IRAS ID

  85377

• Contact name

  Simon Travis

• Sponsor organisation

  AbbVie Ltd

• Eudract number

  2011-002411-29

• ISRCTN Number

  na

• Research summary

  Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). Current treatments for UC do not completely stop the inflammatory process and may cause appreciable side effects. Treatments include anti-inflammatory agents (such as mesalazine or steroids), immunomodulators (drugs that act on the immune system, such as azathioprine) and biologic agents (drugs that work by injection to modify the immune response). In this study all patients will receive adalimumab (a biologic drug). Adalimumab is a synthetic (man-made) antibody that works in a similar way to the natural antibodies produced by our immune system. Natural antibodies recognise harmful substances and bind to them, helping our immune systems to attack them and protect us from infections. Adalimumab targets a protein in the body called TNF-alpha (tumour necrosis factor-alpha). The body naturally produces TNF-alpha as part of its immune response, temporarily causing inflammation in affected areas. By blocking TNF-alpha, adalimumab may reduce inflammation and treat UC. Adalimumab is not yet licensed in the UK for patients with UC, but is licensed in other conditions such as Crohn??s disease. It is believed that adalimumab may help subjects with UC who have incomplete relief of their symptoms with currently available medications, since other studies have shown to be effective for patients whose UC has not responded to treatment with conventional therapy. The main purpose of the study is to investigate the effect of adalimumab on a person??s quality of life, use of health care resources and the costs of care for people with UC in a normal clinical practice setting. Patients in the study will attend hospital visits at week 0, week 2, week 8 and week 26/final visit. Patients will receive treatment with adalimumab for up to 26 weeks.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  11/WM/0390

• Date of REC Opinion

  3 May 2012

• REC opinion

  Further Information Favourable Opinion