Center for Global Research Data

Predicting the short- and long-term risk of serious infections in patients with Crohn’s disease: Analysis of the PYRAMID Registry

Lead Investigator: Siddharth Singh, University of California San Diego
Title of Proposal Research: Predicting the short- and long-term risk of serious infections in patients with Crohn’s disease: Analysis of the PYRAMID Registry
Vivli Data Request: 6551
Funding Source: NIDDK K23DK117058; I will also be applying for NIH funding, through NIDDK PA-18-741
Potential Conflicts of Interest: Dr. Singh reports: Research grant from Janssen and AbbVie
Personal fees from Pfizer for ad-hoc fellowship grant review.

COI Management:
Research grant from AbbVie: The lead PI is not receiving any salary or consulting support from AbbVie, for this independent investigator-initiated project. The project being supported by the grant is independent of the current proposal.
Research grant from Janssen: The lead PI is not receiving any salary or consulting support from Janssen. The project being supported by this grant has been completed in July 2020.
Personal fees from Pfizer: This fees is not for consulting or advising Pfizer. Instead, this is for ad hoc grant review, for research and fellowship grants administered by Pfizer. Pfizer does not have any input on these grants, which are managed by grant review panels.

 

Summary of the Proposed Research:

The overall objectives of this proposal are to accurately predict the short- and long-term risk of serious infections with medications used in the treatment of patients with Crohn’s disease (CD). We hypothesize that pre-treatment clinical factors can identify patients at risk of infections when starting adalimumab (a leading biologic agent used to treat Crohn’s disease) in the short-term (first 6 months). Once patients are on treatment, and disease is better controlled, the risk of serious infection may decrease, by controlling disease effectively and decreasing the need for corticosteroids and/or opiate pain medications, all of which make patients more susceptible to infections. We will also look to predict the long-term risk of infection once patients are on medication and responding to it. This information will provide patients and providers knowledge to tailor therapy based on patients’ predicted risk of treatment-related complications like serious infections.

 

Requested Studies:

An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn’s Disease
Data Contributor: AbbVie
Study ID: NCT01235689
Sponsor ID: M11-271

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of Humira® (Adalimumab) in Subjects with Moderately to Severely Active Crohn’s Disease (CD)
Data Contributor: AbbVie
Study ID: NCT00524537
Sponsor ID: NCT00524537