Lead Investigator: Neeraj Narula, Hamilton Health Sciences
Title of Proposal Research: Comparison of Onset of Efficacy of Therapies for Ulcerative Colitis Based on Patient Symptom Diary Data
Vivli Data Request: 10341
Funding Source: None
Potential Conflicts of Interest: 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 condition that causes inflammation in the colon and rectum, leading to symptoms such as diarrhea, rectal bleeding, and abdominal pain. These symptoms can significantly impact the quality of life for those affected. It is currently unclear how quickly patients with UC who respond to therapy can expect to have improvement in their symptoms. These symptoms can greatly affect a person’s quality of life. Monitoring UC involves using patient-reported outcomes (PROs) like the PRO-2 score, which assesses symptom severity based on stool frequency and rectal bleeding.
Clinical trials in UC often present post-hoc analyses comparing daily symptom diaries between drug-treated and placebo-treated patients. These analyses include all patients, regardless of their response to the therapy, which may potentially dilute the observed effect. Therefore, it is difficult to extrapolate from these analyses how soon responders can expect to experience improvement in their symptoms. Moreover, it is unclear how therapies for UC compare with regards to the time to onset of symptom relief.
This study aims to compare the effectiveness of different therapies for UC by looking at how quickly patients experience symptom relief, using data reported by patients in daily symptom diaries. By focusing on patients who respond to treatment, the study provides valuable insights into how soon symptom improvement can be expected with various therapies, helping both physicians and patients make informed decisions about treatment options.
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 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 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 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, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Data Contributor: Lilly
Study ID: NCT03524092
Sponsor ID: 16823
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
Data Contributor: Lilly
Study ID: NCT03518086
Sponsor ID: 16591
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
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