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Center for Global Research Data

Endoscopic Disease Severity and Patient Reported Outcomes in Crohn’s Disease

Lead Investigator: Neeraj Narula, Hamilton Health Sciences
Title of Proposal Research: Endoscopic Disease Severity and Patient Reported Outcomes in Crohn’s Disease
Vivli Data Request: 6496
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Crohn’s disease (CD) is a type of inflammatory bowel disease that is characterized by periods of relapse and remission. CD affects any area of the gastrointestinal tract but is more common in the ileum and colon. Symptoms of CD include abdominal pain, diarrhea, fever, fatigue and weight loss, which are considered as part of disease assessment. The Crohn’s Disease Activity Index (CDAI) is a tool that combines laboratory values, findings from physical examination, and three patient-reported outcomes (PROs): abdominal pain, number of daily soft/liquid stools and general well-being.

PRO-based endpoints are now required for clinical trials for CD in place of CDAI-based endpoints. However, several studies have identified a disconnect between the CDAI, PROs and objective measures of disease such as endoscopy. Endoscopic remission (ER) remains an important goal of treatment in CD. Recent post-hoc analyses have suggested that PROs at baseline and after the induction phase of treatment are not associated with one-year ER. Further, it has been shown that ulcer size and location at baseline play an integral role in the ability to achieve one-year ER.

In the context of these findings, there is a need to better understand how ulcer size at baseline and post-induction impact the ability to achieve one-year ER. The proposed study aims to analyze data from the UNITI-1, UNITI-2, and IM-UNITI trials (provided by the YODA Project) and the EXTEND trial (provided by Vivli).

Requested Studies:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
Sponsor: Johnson & Johnson
Study ID: NCT01369329
Sponsor ID: CR018415

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease (UNITI-2)
Sponsor: Johnson & Johnson
Study ID: NCT01369342
Sponsor ID: CR018418

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease
Sponsor: Johnson & Johnson
Study ID: NCT01369355
Sponsor ID: CR018421

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn’s Disease Involving the Colon
Sponsor: AbbVie
Study ID: NCT00348283
Sponsor ID: M05-769