A Comparison of the Rapidity of Clinical Response between Infliximab and Tofacitinib for Ulcerative Colitis

Lead Investigator: Neeraj Narula, Hamilton Health Sciences
Title of Proposal Research: A Comparison of the Rapidity of Clinical Response between Infliximab and Tofacitinib for Ulcerative Colitis.
Vivli Data Request: 7321
Funding Source: None
Potential Conflicts of Interest: Neeraj Narula has received a McMaster University Department of Medicine Internal Career Award, and has received honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, Sandoz, Novartis, and Ferring

Summary of the Proposed Research:

Active ulcerative colitis (UC) is a disabling condition and rapid resolution of symptoms is a main concern of both patients and their physicians. There are many choices for initial treatment but very few studies have compared the speed at which remission is achieved between different agents. In this study, we are planning to compare the rapidity of response to infliximab (IFX), a chimeric monoclonal anti-TNF antibody, and tofacitinib (TOF), an oral small molecule JAK inhibitor. We will be using data from the ACT and OCTAVE induction studies.

Requested Studies:

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 Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.
Data Contributor: Pfizer
Study ID: NCT00787202
Sponsor ID: A3921063

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 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