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Active CIRC Studies

STATIC TRIAL: The STopping Aminosalicylate Therapy in Inactive Crohn’s Disease A Randomized, Open-label, Non-inferiority Trial (STATIC)

 

Co-Investigators

Dr. Gordon Moran – UK

Prof. Silvio Danese – Italy

Prof. A. Dorofeyev – Ukraine

Participating Sites [Canada]

University of Alberta, Division of Gastroenterology/Department of Medicine

University of Alberta, Division of Gastroenterology/Department of Medicine

LHSC – University Campus

University of Manitoba

The Office of Dr. Osman Tarabain

Mount Sinai Hospital

University of Calgary

GIRI (GI Research Institute)

McGill University Health Centre (MUHC) Montreal General Hospital

Oshawa Clinic

PerCuro Clinical Research Ltd

Centre Hospitalier Universitaire de Sherbrooke (CHUS) – Hotel-Dieu

 

Multiple Collaborating sites including centres in United Kingdom (UK), Italy, and Ukraine

Purpose

The primary objective is to determine whether withdrawal of aminosalicylates is non-inferior to continuation of aminosalicylates in Crohn’s disease (CD) subjects in remission with regard to a primary endpoint of any CD-related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization, or other complication) within 24 months after enrollment.

 

Study Design

STATIC is a pragmatic, open-label, non-inferiority trial, in which CD patients in remission will be randomized to either continue aminosalicylate therapy or withdraw treatment.

 

Inclusion/Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

 

Targets

Anticipated sample size: 1580

Start: September 2017
Anticipated end: (site activities) MAY 2025
Additional sites are welcome!

Please contact Vipul Jairath at vjairath@uwo.ca

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PRO-ACTIVE FECAL CALPROTECTIN MONITORING TO IMPROVE PATIENT OUTCOMES IN ULCERATIVE COLITIS: A PROSPECTIVE RANDOMISED CONTROL TRIAL (PROMOTE UC)

 

PI: Dr. Greg Rosenfeld, University of British Columbia

Co-Investigators

Dr Yvette Leung

Dr Brian Bressler

Dr Alice Moore

 

Participating Sites

University of British Columbia; St. Paul’s Hospital/Providence Health Care

Mount Sinai Hospital, Toronto, ON

London Health Sciences Centre, ON

Kingston General Hospital

Winnipeg Regional Health Authority – Health Sciences Centre

Hamilton Health Sciences Centre, ON

McGill University Health Centre, QC

Nova Scotia Health Authority, Halifax, NS

[Private Clinic], Kelowna, BC

[Private Clinic], New Westminster, BC

Victoria, British Colombia

Sydney (Liverpool Hospital), Australia

Ottawa Hospital Research Institute, ON

University of Calgary, AB

Thunder Bay Regional Health Sciences Centre, ON

 

Purpose

The purpose of this study is to assess the use of a home-based Fecal Calprotectin measurement as a way to monitor mucosal inflammation in patients with UC and make changes to therapy prior to the onset of clinical symptoms, thereby preventing, delaying or minimizing clinical relapses. All subjects with mild to moderate UC in symptomatic remission are included.

 

Inclusion/Exclusion

Inclusion Criteria

Exclusion Criteria

The objective of this study is to assess the impact of home based FC testing on disease course and outcomes for patients with UC.

 

Targets
Anticipated sample size: 654
Recruitment end date:
Reimbursement provided on a per patient basis. Additional sites are needed and any CIRC member sites interested in participating are invited to contact Greg Rosenfeld at grosenfeld@telus.net

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A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Detection During Screening Colonoscopy in Adult Persons with Colonic Inflammatory Bowel Diseases: A Pilot Study (Short: “IBD-Dysplasia”)

PI:  Sanjay Murthy, Ottawa Hospital Research Institute

Co-Investigators
Dr. Dean Fergusson, Ottawa Hospital Research Institute
Dr. Charles Bernstein, University of Manitoba
Dr. Geoffrey Nguyen, University of Toronto
Dr. Robert Riddell, University of Toronto
Dr. Vipul Jairath, Western University, London, Ontario
Dr. James Conner, University of Toronto

 

Participating Sites

Ottawa Hospital Research Institute, ON
Mount Sinai Hospital, Toronto, ON
London Health Sciences Centre, ON
Hamilton Health Sciences Centre, ON
Thunder Bay Regional Health Sciences Centre, ON
Eastern Regional Health Authority, St. John’s, NL
Nova Scotia Health Authority, Halifax, NS
McGill University Health Centre, QC
Winnipeg Regional Health Authority – Health Sciences Centre
University of Alberta, Edmonton, AB
University of British Columbia; St. Paul’s Hospital/Providence Health Care
Pacific Digestive Health / Royal Jubilee Hospital, Victoria, BC

 

Purpose:
To evaluate the feasibility of conducting a full-scale trial regarding the utility of interval random biopsies during neoplasia screening in colonic IBD (cIBD)

 

Study Design:
We will conduct a multi-centre, parallel-group, non-inferiority RCT. Patients will be randomized 1:1 using a central randomization scheme, stratified by study site. The intervention group will comprise persons undergoing screening using HD-WLE with targeted sampling of visible lesions and the control group (standard of care) will comprise persons undergoing screening using HD-WLE with both random (32 to 40 interval random biopsies) and targeted sampling. Samples interpreted as having neoplasia will be shipped to Mount Sinai Hospital in Toronto for central adjudication. The primary metrics will be feasibility (recruitment, protocol violations, completion of documentation) for the pilot study and efficacy and safety (dysplasia, cancer) for the larger study.

 

Inclusion/Exclusion

Inclusion Criteria
o    ≥ 18 years old
o    History of cIBD involving ≥ 1/3 of colon (histologically)
o    cIBD ≥ 8 years duration
o    In symptomatic remission at time of colonoscopy
o    For CD: Harvey-Bradshaw Index < 5
o    For UC or IBDU: Partial Mayo Score ≤ 2
o    Major purpose of colonoscopy is neoplasia screening/surveillance
o    Undergoing colonoscopy with high-definition white light endoscopy

Exclusion Criteria
o    Persons who cannot provide informed consent
o    Persons with a history of colorectal cancer
o   Persons undergoing colonoscopy to follow-up on recurrent or multifocal dysplasia or recently diagnosed neoplasia
o    Persons undergoing pancolonic chromoendoscopy
o    Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Ottawa or Boston Bowel Preparation Score worse than Excellent or Good)
o    Incomplete colonoscopy
o    Moderate-to-severe macroscopic inflammatory disease involving > 25% of colorectum

 

Targets

Anticipated sample size: 400 (PILOT); 2000 (FULL STUDY)
Anticipated start: Fall 2020
Anticipated end: Spring 2022 (PILOT); 2025 (FULL STUDY)

Additional sites are welcome!

Please contact Sanjay Murthy at smurthy@toh.ca or Janine Ryan at jryan@ohri.ca

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Real World Effectiveness and Safety of Tofacitinib for the Treatment of Patients with Moderate-to-Severe Ulcerative Colitis: A Multicentre Cohort Study

 

PI: Dr. Christopher Ma, University of Calgary
Co-Investigators

Dr. Talat Bessissow, McGill University, Montreal, Quebec
Dr. Brian Bressler, University of British Columbia, Vancouver, British Columbia
Dr. Remo Panaccione, University of Calgary, Calgary, Alberta
Dr. Farhad Peerani, University of Alberta, Edmonton, Alberta
Dr. Vipul Jairath, Western University, London, Ontario
Dr. Christopher Ma, University of Calgary, Calgary, Alberta

 

Participating Centres

University of Calgary
McGill University Health Centre/MUHC
McMaster/Hamilton Health Sciences Centre
London Health Sciences Centre/Western University
University of Alberta, Edmonton
University of Manitoba, Winnipeg
Ottawa Hospital Research Institute (OHRI)

 

Purpose 

Determine the proportion of patients with moderate-to-severe UC achieving clinical and endoscopic remission with tofacitinib at 3, 6 and 12 months after treatment.

 

Study Design

Multicenter retrospective observational cohort study: This will be a combined retrospective and prospective multicenter cohort study evaluating the effectiveness of tofacitinib for inducing and maintaining clinical and endoscopic remission, and the safety of tofacitinib, particularly with respect to serious adverse events that have been raised for this class of treatment.

 

Inclusion/Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

 

Tofacitinib is an oral small molecule drug inhibiting Janus kinase, which controls downstream expression of inflammatory mediators implicated in IBD. Tofacitinib was demonstrated to be effective for induction and maintenance of remission in patients with moderate-to-severe UC. However, real-world data on the effectiveness and safety of tofacitinib are lacking. Robust real world evidence evaluating treatment patterns, clinical effectiveness, and safety outcomes of tofacitinib will inform routine clinical practice.

 

Targets

Anticipated sample size n=216
Anticipated start: Fall 2020
Anticipated end: Fall 2022

Reimbursement provided on a per patient basis. Additional sites are welcome!

Please contact Christopher Ma at christopher.ma@ucalgary.ca

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Efficacy of Ustekinumab for the Treatment of Bio-Naïve Moderate-to-Severe Crohn’s Disease Patients: Real-World Data

 

PI: Talat Bessissow, McGill University

Co-Investigators
Dr. Joannie Ruel, Université de Sherbrooke, Sherbrooke, Quebec
Dr. Christopher Ma, University of Calgary, Calgary, Alberta
Dr. Remo Panaccione, University of Calgary, Calgary, Alberta
Dr. Brian Bressler, University of British Columbia, Vancouver, British Columbia
Dr. Vipul Jairath, Western University, London, Ontario
Dr. Neeraj Narula, McMaster University, Ontario

 

Participating Sites

TBD

 

Purpose

To assess the rate of clinical remission at 12 months of treatment with UST

 

Study Design

Retrospective multicentre observational cohort study evaluating the real-world efficacy of UST for Canadian patients with moderate-to-severe Crohn’s disease that have not been exposed to a previous biologic agent.

 

Inclusion/Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

 

Ustekinumab (UST), a monoclonal antibody that blocks the P40 subunit that is shared between interleukin (IL)12 and 23 is approved by health authorities for the treatment of Crohn’s disease. It is well known that bio-naïve patients have better remission rates than those with previous exposure to other biologics. However, in most jurisdictions, UST cannot be used in bio-naïve patients because of limitations from payers. A robust Real-world study evaluating the efficacy of UST in bio-naïve CD patients will inform clinical practice and inform about the positioning of UST with regards to other biologics.

 

Targets

Anticipated sample size: 150
Anticipated start: Fall 2020
Anticipated end: Fall 2021
Reimbursement provided on a per patient basis. Additional sites are welcome!

Please contact Talat Bessissow at talat.bessissow@mcgill.ca

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Fecal Microbiota Transplantation for Active Pouchitis: A Randomized Controlled Trial

 

PI: Dr. Neeraj Narula, McMaster University

Co-Investigators
Dr. Paul Moayyedi, McMaster University
Dr. John Marshall, McMaster University
Dr. Geoffrey Nguyen, Mount Sinai Hospital
Dr. Vipul Jairath, Western University
Dr. Dina Kao, University of Alberta
Dr. Karen Wong, University of Alberta
Dr. Charles Bernstein, University of Manitoba
Dr. Jeffrey McCurdy, University of Ottawa

 

Participating Sites

McMaster University Medical Centre/Hamilton Health Sciences Centre

Winnipeg Regional Health Authority – Health Sciences Centre

Ottawa Hospital Research Institute, ON

 

Purpose

The study objectives are to learn about a) if alteration of the microbiota through fecal microbiota transplantation in pouchitis helps improve disease symptoms and improve endoscopic inflammation; and b) understand the changes that occur in the gut bacteria during fecal transplantation.

 

Inclusion/Exclusion Criteria

Inclusion criteria

Exclusion criteria

After participating in the six-week trial of FMT or placebo intervention once weekly, all patients are offered open-label FMT weekly by enema for six weeks.  Responders to FMT are also offered maintenance treatment every 2 weeks subsequently, should they elect to continue, for up to an additional 40 weeks.

 

Targets

Anticipated sample size: 50

Start: April 1, 2019
Anticipated end: December 1, 2021
Reimbursement provided on a per patient basis. Additional sites are welcome!

Please contact Neeraj Narula at neeraj.narula@medportal.ca

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Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs

Waqqas Afif, MD, M.Sc., FRCPC
Associate Professor of Medicine, McGill University Health Centre

Co-PI: Dr. Sasha Bernatsky (Rheumatology)

Co-investigators
Dr. Daniel Baumgart, University of Alberta
Dr. Sophie Plamondon, University of Sherbrooke
Dr. Yvette Leung, University of British Columbia
Dr. Christopher Ma, University of Calgary, Calgary, Alberta
Dr. Geoff Nguyen, Mount Sinai Hospital
Dr. Neeraj Narula, McMaster University, Ontario
Dr. Joannie Ruel, Université de Sherbrooke, Sherbrooke, Quebec
Dr. Harminder Singh, University of Manitoba
Dr. Laura Targownik, University of Manitoba

 

Participating Sites

Winnipeg Regional Health Authority – Health Sciences Centre

University of British Columbia

McMaster/Hamilton Health Sciences Centre

Mount Sinai Hospital, Toronto, ON

Montreal General Hospital

University of Calgary

IBD Quebec

University of Alberta (RAPPORT)

University of Alberta, Edmonton, AB

CIUSSE-CHUS (The Quebec Multicentre Mechanism )

Institut de recherche en rheumatologie de Mtl (IRRM)

 

Purpose

Our study aims to provide real-world evidence on the comparative effectiveness and safety of biosimilar drugs versus their bio-originators.

 

Study Design

Our primary objective is to compare patients who are starting on/switching to biosimilar drugs or their equivalent legacy drugs. We will be collecting data prospectively but some centres will share retrospective data as well.

 

Inclusion/Exclusion

Our study will include patients 18 years and older, with a clinical diagnosis of inflammatory rheumatic disease (either RA or AS), or IBD (CD or UC) who have given their informed consent. There are no disease activity criteria for entry. We will enrol all patients starting on a biosimilar or its bio-originator (as of 2020, for IBD the only biosimilar is infliximab, but adalimumab biosimilar is also on the horizon). Patients are not required to be biologic-naïve. At baseline and follow-ups, information on disease activity, co-morbidity, concomitant medication, and other variables are collected. The minimum information required is time on medication (or time to medication discontinuation) but more detailed analyses (including reasons for discontinuation and effectiveness for disease control, etc.) will be done for centres able to provide that data.

 

Targets

Anticipated sample size: 400
Anticipated start: Already started
Anticipated end: December 2022
Reimbursement provided on a per patient basis. Additional sites are welcome!

Please contact Dr. Waqqas Afif at waqqas.afif@mcgill.ca