Lead Investigator: Vipul Jairath, University of Western Ontario
Title of Proposal Research: Impact of concomitant baseline medication on efficacy of biologics and small molecules for Inflammatory Bowel Disease
Vivli Data Request: 7850
Funding Source: None
Potential Conflicts of Interest: Dr. Jairath reports: Consulting fees from AbbVie, Alimentiv Inc, Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Reistone Biopharma, Roche, Sandoz, Second Genome,Takeda, Teva, Topivert, Ventyx, and Vividion.
Speaker’s fees from, Abbvie, Ferring, Galapagos, Janssen Pfizer Shire, Takeda, and Fresenius Kabi.
Financial salary support from the John and Susan McDonald Endowed Chair at Western University, London, Ontario, Canada
These conflicts of interest will be disclosed when the research is presented and published.
Dr. Singh reports: Institutional research grants from AbbVie (completed 2020), Janssen (completed 2020) and Pfizer (active).
Personal fees from Pfizer for ad hoc grant review.
Summary of the Proposed Research:
Inflammatory bowel disease (IBD) is a condition that causes chronic inflammation to the gastrointestinal (GI) tract. The two types of IBD include ulcerative colitis (UC) and Crohn’s Disease (CD). In UC, inflammation occurs in the colon and rectum, mainly affecting the inner lining of the colon. For CD, inflammation occurs in any part of the GI tract from mouth to anus, affecting multiple layers of the small intestinal and colon. IBD is a common disease, with 6.8 million people around the world who suffer from it. There is currently no cure for IBD, however there are several types of medications that can be used to treat the disease including aminosalicylates, corticosteroids, immunomodulators, antibiotics, biologic therapies and small molecule drugs.
Given that patients with IBD may be on a variety of different medications to help manage their condition, it is important to understand whether the medications a patient is currently taking at the start of a trial modifies the efficacy of the new drug being studied. For example, we would be interested in whether the new drug is more or less effective for patients on steroids at the start of a study, compared to patients not on steroids. This is important to establish as the results could influence how we interpret the results of clinical trials and how clinicians use treatments in routine practice, such as prescribing the drug to most effective groups of patients. The results will also guide the design of future clinical trials. Published clinical trials usually do not present effect modification of new drug by baseline medications. Such results can only be obtained through access to patient level data from clinical trials.
In this study, we want to specifically look at whether the use of concomitant steroids, aminosalicylates (5ASA), immunosuppressants (azathioprine, methotrexate), protein pump inhibitors (PPI), antidepressants, or opioid use at baseline in patients with IBD, impacts the efficacy of the investigational drug. By identifying the impact of these medications used at baseline, it may help improve the design of future studies as well as help guide treatment decisions for patients with IBD.
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 (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 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, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease
Data Contributor: Takeda
Study ID: NCT01224171
Sponsor ID: C13011
Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab’ Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn’s Disease.
Data Contributor: UCB
Study ID: NCT00552058
Sponsor ID: C87085
ACCENT I – A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn’s Disease
Data Contributor: Johnson & Johnson
Study ID: NCT00207662
Sponsor ID: CR004771
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 Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
Data Contributor: Pfizer
Study ID: NCT01465763
Sponsor ID: A3921094
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.
Data Contributor: Pfizer
Study ID: NCT01458951
Sponsor ID: A3921095
A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00488774
Sponsor ID: CR014188
A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00487539
Sponsor ID: CR014176
A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: AbbVie
Study ID: NCT00385736
Sponsor ID: M06-826
A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00096655
Sponsor ID: CR004783
A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00036439
Sponsor ID: CR004777
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT02407236
Sponsor ID: CR106920
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Data Contributor: Takeda
Study ID: NCT00783718
Sponsor ID: C13006
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: AbbVie
Study ID: NCT00408629
Sponsor ID: M06-827