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Active CIRC Studies

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

STATIC TRIAL
The STopping Aminosalicylate Therapy in Inactive Crohn’s Disease A Randomized, Open-label, Non-inferiority Trial (STATIC) is open and recruiting participants. 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.  The study involves a screening and enrollment visit, then follow up visits at 6, 12 and 24 months.

A total of 114 patients have been randomized so far into STATIC.

Canada:
3 Additional sites are being sought in Canada to capitalize on geographic proximity and to hopefully engage potential new or new to research investigators.

UK:
The UK sites have progressed well and are benefiting from general practitioner ‘PIC’ sites (Patient Identification Centres).  PIC sites can run a search through their in house electronic medical records and send out invitation letters to potential participants.  Participants are screened by the GP and passed along to a referral centre.

Ukraine:
The sites in Ukraine are looking to launch in late spring.  PIs are already exploring the use of EMR to find patients for STATIC

Italy:
Italian submissions are currently ongoing, with site start up due next month.

Where can I find more information?

https://www.static-trial.com

Lee Williamson
Robarts Project Manager
STATIC@robartsinc.com

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Pro-Active Fecal Calprotectin Monitoring to Improve Patient Outcomes in Ulcerative Colitis: A Prospective Randomized Control Trial (PROMOTE UC)

Study Lead

Dr. Greg Rosenfeld, MHSc, FRCPC, CCFP

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.

As of February 18, 2020, 192 patients have been recruited across the 8 active sites (out of 19 sites). Total enrolment is 654 with a target of 50 – 60 per site.

Anticipated sample size: 654

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

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

Study Design:
We will conduct a multi-centre, parallel-group, non-inferiority RCT in adult persons with colonic IBD of ≥ 8 years duration who are undergoing colonoscopy screening as part of routine care. 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 (30 to 40 interval random biopsies) and targeted sampling. .Patients who consent to participate will undergo an observed screening colonoscopy and a 2-week post-procedure telephone or in-person brief interview. Samples interpreted as having neoplasia will be shipped to Mount Sinai Hospital in Toronto for adjudication by two expert IBD pathologists. All study information will be collected on an electronic platform and sent directly to the Ottawa Methods Centre for storage and analysis. Recruitment for the pilot study will stop at 1 year or once 400 patients are recruited

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 or are unwilling to provide informed consent
o    Persons with a history of colorectal cancer
o   Persons undergoing colonoscopy to follow-up on 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

Anticipated sample size: 400 A
Anticipated start: Spring 2020
Anticipated end: Spring 2022 Site

Start-up: $2000
Reimbursement per patient: $400

Additional sites are welcome!

Please contact Sanjay Murthy at smurthy@toh.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

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. 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.

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

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. Therefore, most of published real-world data is in patients that used UST as a rescue therapy after failing another biologic. This will be a 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. We will include up to 10 Canadian sites participating in the CIRC concortium. Adult patients (age > 18) will be included if they meet the following criteria: (a) confirmed diagnosis of CD based on clinical and endoscopic, or radiographic data; (b) active clinical symptoms attributed to CD before starting UST; (c) graded as moderately to severely active disease before starting UST based on endoscopic or radiographic assessment, and/or clinical assessment (graded as moderate or severe based on Harvey–Bradshaw Index score of 8–16 or >16, respectively); (d) had at least one clinical and/or endoscopic follow-up after initiation of therapy. The primary objective is to assess the rate of clinical remission at 12 months of treatment with UST. 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.

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. Geoff 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

The study objectives are to learn about a) if alteration of the microbiota 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 criteria
1.     Patients aged 18 or over
2.     Active pouchitis defined as PDAI of 7-18 points, with endoscopic subscore at > 2
3.     Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance

Exclusion criteria
1.     Participating in another clinical trial
2.     Unable to give informed consent
3.     Severe comorbid medical illness
4.     Concomitant Clostridium difficile infection
5.     Increase in medical therapy for pouchitis in the last 4 weeks.  Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNFa therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥8 weeks prior to randomization.  Stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again.  Stable intake of probiotic therapy also permitted.
6.     New antibiotic therapy in the last 28 days.
7.     Pregnant women.
8.     Clinically significant lactose intolerance
9.     Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results

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.

Anticipated sample size: 86

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


PI: 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. Edmond-Jean Bernard, University of Montreal
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

The Canadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research (CAN-AIM) team was funded by CIHR through the Drug Safety and Effectiveness Network (DSEN), in partnership with Health Canada and other regulatory parties. CIRC members are a part of a new initiative to build a biosimilars registry with the intent of providing real-world information on biosimilar use to the Office of Pharmaceuticals Management Strategies, Strategic Policy Branch of Health Canada, and other regulators.The aim of the study is to compare the safety and effectiveness of biosimilar drugs to the originator biologic medication. The primary focus is on patients without a history of biologic drug use but we will also study patients switching to a biosimilar from the originator, as well as patients switching to a biosimilar (or its equivalent originator biologic) from an alternative biologic therapy. We will measure how long patients stay on the therapy, if they require other types of treatment (e.g.: steroids), if their disease control improves, and the occurrence of side effects (e.g.: infections).

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 Waqqas at waqqas.afif@mcgill.ca