Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the relationship between microscopic Geboes index of
      inflammation and clinical course of ulcerative colitis in patients treated with infliximab.
      The investigators propose to test the hypothesis if infliximab is able to induce histological
      remission and then change the clinical course of ulcerative colitis.
    

Detailed description: 
      Correlations between histologic disease activity and other assessments of clinical disease
      activity are not well established despite a good correlation being found between endoscopy
      and histology, especially during active ulcerative colitis (1,2). Endoscopic healing induced
      by infliximab in Crohn's disease patients was associated with a significant reduction in
      surgeries and hospitalizations (3). Histological recovery in ulcerative colitis is often
      incomplete and some studies have shown that microscopic evidence of inflammation is common
      even in patients with clinically and quiescent colitis assessed by sigmoidoscopy (4,5).
      Although this fact has not yet been completely elucidated, it is suggested that some patients
      with residual microscopic acute inflammation may be more prone to relapse (2). The prognostic
      importance of microscopic inflammation is unknown. Given that the rectum is always involved
      in ulcerative colitis and inflammatory activity is diffuse and restricted to the mucosa, the
      collection of samples from the rectal and sigmoid mucosa are potentially useful tools for
      evaluating disease severity. In addition, there is a strong correlation between the levels of
      calprotectin and the degree of inflammation as assessed by endoscopic and histologic criteria
      (6). Therefore, the measurement of faecal calprotectin and lactoferrin may also provide as
      valuable non-invasive tools to assess disease activity and optimize the treatment in UC
      patients.

      Histologically, active disease is defined by the presence of neutrophils in conjunction with
      epithelial cell damage. Analysis generally relies on the examination of H & E-stained
      sections. Two samples are suggested as more appropriated because it is well-known that
      treatment may induce variations in the expression of inflammation intensity. Several
      histological scores were proposed, however, Geboes index (7) has been validated and tested
      for reproducibility and has 5 domains: structural change, chronic inflammatory infiltrate,
      lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and
      erosion or ulceration. The Geboes index has a more elaborated grading of crypt lesions and
      surface epithelial damage than other proposed indexes. The aim of this study is to assess the
      relationship between microscopic Geboes index of inflammation and clinical course of
      ulcerative colitis in patients treated with infliximab. The investigators propose to test the
      hypothesis if infliximab is able to induce histological remission and then change the
      clinical course of ulcerative colitis
    

Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): 5 mg/Kg, I.V. at weeks 0, 2, 6 and every 8 weeks thereafter
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infliximab; ulcerative colitis; histologic remission