Evaluating 2 Treatment Algorithms in Moderate-severe Crohn's disease

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

• IRAS ID

  58047

• Contact name

  Simon Travis

• Sponsor organisation

  Abbott Laboratories Limited

• Eudract number

  2010-020137-10

• ISRCTN Number

  N/A

• Research summary

  The current treatments prescribed for the treatment of Crohn's disease (CD) do not completely stop the inflammatory process and have significant side effects. Treatments include anti-inflammatory agents (also known as steroids, such as prednisone), immunomodulators (drugs that treat disorders of the immune system such as azathioprine) and biologic agents (for example adalimumab). In this study prednisone, azathioprine and adalimumab will be used as study medications. This study will compare two treatment strategies for patients with moderate to severe CD, the aim is to show that tight control of disease activity using strict criteria based clinical symptoms, blood tests and steroid use improves the rate of mucosal healing (mucosa is membrane layer of the intestines) at Week 56, as compared to treating patients using less strict criteria based on clinical symptoms and steroid use only.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/55

• Date of REC Opinion

  20 Sep 2010

• REC opinion

  Further Information Favourable Opinion