Effect of Infliximab on MRI lesions in Crohn's - ACTIF study

• Research type

  Research Study

• Full title

  An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial.

• IRAS ID

  14590

• Sponsor organisation

  University of Leuven Hospitals

• Eudract number

  2006-004784-58

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Crohn's disease (CD) is a condition of unknown cause that results in inflammation of the full thickness of the small bowel and colon. Infliximab is an antibody drug treatment that has potent antinflammatory effects in Crohn's disase. Maintenance therapy with infliximab has been shown to result in healing of the lining of the colon. It is licensed for use in patients not responding to other forms of treatment (eg steroids or immune-suppressants). Thickening of the bowel wall with scarring and narrowing is a complication of Crohn's disease that may result in bowel obstruction and sugery though the flunce of infliximab on the evolution of these changes in the small bowel is not clear. This is an observational study designed to assess the effect of infliximab on small bowel inflammation, thickness and narrowing using advanced Magnetic Resonance Imaging (MRI) scanning techniques. Patients with moderate to severe small bowel Crohn's disease (total 25 in 5 centres) requiring infliximab therapy will receive standard 3 dose induction therapy and then 8 weekly maintenance infliximab infusions for the duration of the study. In addition to this, patients will complete disease activity scores and have an MR enteroclysis scan (MRE) at baseline and weeks 2 and 26. Clinical follow up will be for a total of 2 years. MRE involves passage of a thin naso-gastric feeding tube through which air and contrast are infused prior to MRI scanning - this technique provides optimal cross-sectional imaging of the small bowel. As an observational study, patients will be treated according to standard clinical guidelines. In demonstrating the effect of infliximab on full thickness small bowel inflammation using MRI scanning, this study will provide important information to clinicians about the potential for long term benefit in disease progression using this drug, which may ultimately support earlier treatment.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/19

• Date of REC Opinion

  24 Apr 2009

• REC opinion

  Further Information Favourable Opinion