ROCHE_MA39975
Research type
Research Study
Full title
A MULTICENTER, RETROSPECTIVE, OBSERVATIONAL STUDY TO EVALUATE THE ASSOCIATION BETWEEN HISTOLOGICAL REMISSION AND LONG-TERM OUTCOMES IN PATIENTS WITH ULCERATIVE COLITIS
IRAS ID
283096
Contact name
Christian Selinger
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd.
Duration of Study in the UK
0 years, 9 months, 10 days
Research summary
This is an observational non-interventional (NIS) study in patients with ulcerative colitis. This study will use secondary data (demographic, clinical, laboratory values, endoscopy scores) as well as histology data derived from biopsy samples collected during routine clinical practice. There will be approximately 550 patients enrolled in the study. This study will be carried out by the sponsor F.Hoffman-La Roche Ltd.
There is no study drug. This is a retrospective chart study. Only patients previously recorded data will be used.
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory bowel disorder that causes continuous intestinal inflammation of the mucosal surface, extending from the rectum proximally through the entire colon. The disease results from a complex interplay between environmental, genetic and microbial factors, and dysregulated immune response. Patients with UC typically present with haematochezia (bloody stool), bloody diarrhoea with or without mucus, rectal urgency, tenesmus (a sense of pressure), and variable degrees of abdominal pain.
The treatment pattern for UC is shifting from subjective, patient-reported measures such as stool frequency in favour of objective measures such as endoscopic remission-a concept for which there is no validated definition but is loosely defined as the endoscopic absence of friability, blood, erosions, and ulcers in all visualised segments of gut mucosa. Besides endoscopic evaluations, histology may also be used to assess therapeutic benefit for UC.
The objective of this study is to assess whether histological remission, defined as no neutrophils and measured by Nancy Histology index (NHI) or Robarts Histopathology index (RHI) plus Geboes, is associated with improved long-term outcomes. Specifically, comparing rates of long- term outcomes in UC patients who achieve histological remission shortly after initiating treatment with a biologic or a small molecule to those who do not achieve histological remission.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
20/SW/0145
Date of REC Opinion
5 Oct 2020
REC opinion
Favourable Opinion