Center for Global Research Data

A Study to Assess the Correlation Between Harvey Bradshaw Index and Patient Reported Outcome 2 in Crohn’s Disease Patients Enrolled in Large Scale Randomized Controlled Trials

Lead Investigator: Reena Khanna, Lawson Health Research Institute
Title of Proposal Research: A Study to Assess the Correlation Between Harvey Bradshaw Index and Patient Reported Outcome 2 in Crohn’s Disease Patients Enrolled in Large Scale Randomized Controlled Trials
Vivli Data Request: 7404
Funding Source: None
Potential Conflicts of Interest: Consulting with Takeda. This will be disclosed. The topic of interest is independent of molecule and related to outcome measure validation.

Summary of the Proposed Research:

Crohn’s disease (CD) is a chronic inflammatory condition of the gastrointestinal tract that is characterized by repeated episodes of abdominal pain, diarrhea, and weight loss. This disease predominantly affects the young, resulting in poor quality of life and can lead to severe consequences including colorectal cancer.

The Impact Report by Crohn’s and Colitis Canada in 2012 conservatively estimated the total annual direct and indirect costs of inflammatory bowel disease at $11,900/person. In 2012, 104,000 Canadians were living with CD, equating to a total national cost of over $1.5 billion annually; thus, effective strategies are needed for optimizing medical care for CD while reducing the risk of side effects and minimizing costs. The use of drug concentrations enables optimization of therapies.

Several clinical indices are available for use when treating the disease, including the Harvey Bradshaw Index (HBI) and Patient Reported Outcome 2 (PRO2). However, it is not clear which index is best for use in clinical practice. This study will assess how closely the two indices agree with each other and with other markers of disease activity to help guide tools in practice. It will also help clinicians interpret data.

The authors proposed to assess data from large trials that have been published to assess the correlation between the clinical indices and other markers of disease activity. Since these data have already been collected it will provide an answer relatively quickly.

Requested Studies:

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn’s Disease
Data Contributor: Takeda
Study ID: NCT00783692
Sponsor ID: C13007

A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn’s Disease
Data Contributor: Takeda
Study ID: NCT00790933
Sponsor ID: C13008