Lead Investigator: Neeraj Narula, Hamilton Health Sciences
Title of Proposal Research: Impact of Concomitant Steroid Use on Adverse Events in Ulcerative Colitis Clinical Trials
Vivli Data Request: 10381
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:
Ulcerative colitis (UC) is a chronic bowel disease that causes inflammation in the colon, the part of the digestive system that stores and processes waste. Symptoms of UC involve diarrhea, bleeding from the rectum, and stomach pain. For some people, these symptoms are so severe that they need stronger treatments. These treatments include biologic drugs and small molecule therapies.
Biologics are a type of drug made from living cells and can help reduce inflammation. Examples are infliximab, vedolizumab, and adalimumab, and clinical trials have shown they can be very effective. Small molecule therapies, such as tofacitinib, are another option. These are a type of drug therapy made using small organic compounds in a laboratory. They can pass through cell membranes to reach targets inside cells and are usually taken orally. Both biologics and small molecules have changed the way doctors treat UC.
Another common treatment is corticosteroids, often known simply as steroids. They are anti-inflammatory medicines used for a wide range of conditions, including UC, and can help manage flare-ups. However, they have side effects if used for a long time. These side effects can include infections, cancer, and other serious problems. Researchers are concerned about what happens when corticosteroids are used along with biologics or other immune-suppressing drugs. Current literature lacks direct comparisons on whether people with UC who use corticosteroids along with biologic treatments have more side effects compared to those who don’t use corticosteroids. Maintenance therapy refers to ongoing treatment used to keep a disease under control and prevent flare-ups or worsening symptoms over time. This study aims to fill this gap by evaluating whether ongoing corticosteroid use during maintenance therapy correlates with higher Adverse Event (AE) rates compared to patients who cease corticosteroids or never used them.
The primary objective of this study is to evaluate whether patients who continue to use corticosteroids during maintenance within clinical trials have a higher rate of AEs compared to those who stopped corticosteroids and those not using steroids. To do this, we are requesting detailed patient information from several clinical trials: ULTRA 2, GEMINI 1, VARSITY, and OCTAVE-1 from Vivli, and ACT 1 and PURSUIT from the YODA Project.
Requested Studies:
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
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: 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 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 Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00488631
Sponsor ID: CR014179
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 Inc.
Study ID: NCT01465763
Sponsor ID: A3921094
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 Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Data Contributor: Takeda
Study ID: NCT02497469
Sponsor ID: MLN0002-3026