Lead Investigator: Neeraj Narula, Hamilton Health Sciences
Title of Proposal Research: Assessing the Impact of Disease Duration on the Likelihood of Healing in the Ileum and Colon in Crohn’s Disease
Vivli Data Request: 10706
Funding Source: None
Potential Conflicts of Interest: Neeraj Narula holds a McMaster University Department of Medicine Internal Career Award. Neeraj Narula has received honoraria from Janssen, Abbvie, Takeda, Pfizer, Merck, Lupin and Ferring. None of the listed conflicts of interest are aware of or are involved in this research
Summary of the Proposed Research:
Crohn’s disease (CD) is a long-term condition that causes inflammation in the digestive system, often affecting the lower part of the small intestine (ileum) and the large intestine (colon). It can lead to various symptoms, including abdominal pain, diarrhea, and weight loss. This disease affects millions of people worldwide, significantly impacting their quality of life.
Understanding how CD heals in different parts of the digestive system is crucial, as it can influence treatment effectiveness. One important measure of healing is endoscopic remission (ER), which indicates a reduction in disease activity. ER is commonly evaluated using a scoring system that rates the severity of the disease during an examination of the intestines.
Recent advancements have introduced a modified version of this scoring system, which provides a more detailed assessment of healing and its potential impact on patient outcomes. Achieving ER is vital because it is linked to better long-term health, including fewer relapses, lower hospitalization rates, and reduced need for surgery. However, many factors, such as the duration of the disease, can affect the likelihood of achieving ER. For instance, research has shown that patients with CD for less than two years had a higher chance of achieving ER compared to those with the disease for over five years.
The healing process may differ between the ileum and colon, and there is ongoing research to explore how the duration of the disease affects healing in these areas. Some studies suggest that ulcers in the ileum may be harder to treat than those in the colon. Factors like scar tissue formation from long-standing disease could complicate healing.
This research aims to enhance our understanding of Crohn’s disease and improve treatment strategies. By examining how disease duration affects healing in different parts of the digestive system, we hope to identify more effective approaches for patients. The study will involve clinical trials to gather data on patient outcomes based on various treatment methods. This knowledge could lead to better care for those affected by Crohn’s disease, ultimately improving their quality of life.
Requested Studies:
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
Data Contributor: AbbVie
Study ID: NCT00348283
Sponsor ID: M05-769
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
Data Contributor: AbbVie
Study ID: NCT03345849
Sponsor ID: M14-433
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Data Contributor: AbbVie
Study ID: NCT03345836
Sponsor ID: M14-431
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)
Data Contributor: 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)
Data Contributor: 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
Data Contributor: Johnson & Johnson
Study ID: NCT01369355
Sponsor ID: CR018421
A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn’s Disease
Data Contributor: Johnson & Johnson
Study ID: NCT03464136
Sponsor ID: CR108449
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
Data Contributor: Takeda
Study ID: NCT02611817
Sponsor ID: MLN0002SC-3031
An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn’s Disease Treated With Vedolizumab IV
Data Contributor: Takeda
Study ID: NCT02425111
Sponsor ID: MLN0002-3028