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currently recruiting studies

Crohn's Disease - PATHFINDER Study

PI:  Dr. Neeraj Narula

Contact: Jaiminkumar Patel

patej102@mcmaster.ca

A Pragmatic, Active-comparator, Parallel-group, Randomized Trial to Evaluate the Optimal First-line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn’s Disease

 

The purpose of this study is to look at all current standard of treatment biologic drugs available,

to compare the effectiveness and safety of each in order to determine the best first-line

treatment for Crohn’s disease.

MIRIAD

PI:  Dr Neeraj Narula,, 

Contact: Jaiminkumar Patel

patej102@mcmaster.ca

A Pragmatic, Active-comparator, Parallel-group, Randomized Trial to Evaluate the Optimal First-line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn’s Disease

 

The purpose of this study is to look at all current standard of treatment biologic drugs available,

to compare the effectiveness and safety of each in order to determine the best first-line

treatment for Crohn’s disease.

SHIFT - IBD

PI:  Dr. Neeraj Narula

Contact: Jaiminkumar Patel

patej102@mcmaster.ca

Switching to high-efficacy anti-IL-23 guselkumab in ustekinumab exposed persons with active IBD

 

This study is being conducted to see how well Tremfya works in people who switched from Ustekinumab, also known as Stelara, because it was not effective enough.

All IBD - The QUOTIENT Trial

PI:  Dr. Neeraj Narula, 

Contact: Jaiminkumar Patel 

patej102@mcmaster.ca

Treat-to-Target of Endoscopic Remission in Patients with IBD in Symptomatic Remission

The objective of the study is to compare the effectiveness, burden, and safety of switching to an alternative therapy for achieving endoscopic remission versus continuing the current treatment in asymptomatic patients with inflammatory bowel disease (IBD) and ongoing endoscopic inflammation, while also identifying heterogeneity of treatment effects through preplanned subgroup analyses.

Ulcerative colitis - RESCUE-UC

PI:  Dr. Neeraj Narula,

Dr. John Marshall

Contact: Jaiminkumar Patel

patej102@mcmaster.ca

Comparison of medical RESCUE strategies for patients with steroid-refractory acute severe Ulcerative Colitis: an open-label randomized controlled trial.

The primary objective of this study is to evaluate whether treatment success in patients with Acute Severe Ulcerative Colitis who are treated with strategy U (Upadacitinib) is non-inferior to strategy C (conventional rescue therapy), after 16 weeks of initiating therapeutic management.

Ulcerative Colitis - FUEL Study

PI:  Drs. Paul Moayyedi, Neeraj Narula, Smita Halder, John Marshall

Contact: Melanie Wolfe

wolfe@hhsc.ca

This is an open label study with all UC patients receiving FMT.


Primary objectives: Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) < 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).

Maintenance of remission of UC after three years in those who achieve initial remission with FMT.  This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy.

Ulcerative Colitis - REMIT-UC-UPA Study

PI:  Dr. Neeraj Narula, 

Contact: Jaiminkumar Patel

patej102@mcmaster.ca

Real-World Effectiveness and Safety of Upadacitinib for Achieving Endoscopic Remission in Moderate-to-Severely Active Ulcerative Colitis: A Prospective, Multicenter Canadian IBD Research Consortium Cohort Study (REMIT-UC-UPA)

 

The primary objective of this study is to evaluate the cumulative proportion of UC patients achieving endoscopic remission (defined by MES=0) within 12 months of initiating upadacitinib therapy.

Crohn’s disease - VICTRIVA (Vedolizumab Combination Therapy for the Treatment of patients with Active Crohn’s disease)

PI:  Drs. Neeraj Narula, Smita Halder, John Marshall

Contact: Jaiminkumar Patel 

patej102@mcmaster.ca

A Randomized, Double-blind, Placebo-Controlled Phase 3b Study to Evaluate the Short and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab Monotherapy for the Treatment of Adult Participants With Moderately to Severely Active Crohn’s Disease

 

The Primary Objective is to evaluate whether dual-targeted therapy (DTT; vedolizumab and upadacitinib) during induction improves clinical and endoscopic outcomes by Week 12, compared with vedolizumab monotherapy, in participants with moderately to severely active Crohn’s disease (CD).

DRIVE-UP

PI:  Dr. Neeraj Narula, 

Contact: Jaiminkumar Patel 

patej102@mcmaster.ca

A Double-blind Randomized Placebo-controlled Investigation of Vancomycin Efficacy in Patients with Ulcerative Colitis and Primary sclerosing cholangitis (DRIVE-UP) – A Pilot Study

 

The purpose of this study is to find out how safe oral vancomycin is and how well it works compared to a placebo in people with PSC-UC. Vancomycin is an antibiotic taken by mouth, and some early studies have shown it might help reduce colitis symptoms and improve liver problems. This study will collect new, carefully controlled evidence to better understand its effects.

Crohn’s disease with Permanent Ileostomy: Endotrial

PI:  Dr. Neeraj Narula, 

Contact: Jaiminkumar Patel 

patej102@mcmaster.ca

Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants with Permanent Ileostomy

The primary aim is to develop a novel O-PRO and O-EI outcome measure for participants with CD and permanent ileostomy.

Canadian Inflammatory Bowel Disease (IBD) Research Consortium (CIRC) Research Database

PI:  Dr. Neeraj Narula, 

Contact: Jaiminkumar Patel 

patej102@mcmaster.ca

The CIRC Research Database is an initiative where we strive to collect information about the lives and the health of persons who have IBD across Canada. Researchers can use the data we collect from our patients as part of routine clinical care to improve our understanding of how we can provide the best care for people like yourselves who either have IBD or who may have IBD in the future.  There are hospitals across Canada, just like this one, participating in this database.

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