Highlighted Research:

Development of the Robarts Histopathology Index

Whilst endoscopic mucosal healing is accepted as the current treatment goal in ulcerative colitis (UC), this treatment target is not “curative.” Disease relapse nevertheless occurs in patients who meet this outcome despite ongoing therapy and is frequently associated with persistent histological disease, present in approximately one-quarter of patients with normal appearing mucosa. Histological assessment has the potential to become the gold standard measure of inflammatory bowel disease activity, and outcomes assessing microscopic inflammation are now included as key endpoints in clinical trials for UC and increasingly Crohn’s disease. We recognized the need for a validated histological index for use in drug development and developed the Robarts Histopathology Index (RHI). The RHI is a valid instrument that exhibits highly consistent inter-observer reliability, and which is responsive to change in disease activity. This freely available index is now a component of disease activity assessment for the majority of drug development programs and may be easily derived from the Geboes score. The RHI is also an integral component of the UC-100, a highly responsive instrument that we developed for use in early drug development for UC.

Development of Patient-Reported Outcome Measures for Ulcerative Colitis and Crohn’s Disease.

A number of modalities are available for objective measurement of inflammatory bowel disease (IBD) activity (endoscopy, histopathology, imaging, biomarkers) however the goals of therapy must also include improvements in disease characteristics that are important to patients–those which improve their function and well-being. Patient-reported outcomes (PROs) are considered the gold standard for quantifying patient experience by regulatory agencies and are currently recommended as a component of disease assessment in registration trials of therapies for IBD. Although PROs are widely used to study chronic diseases, a limitation to drug development in IBD specifically has been a lack of PROs that meet the regulatory standards for index development. We developed the Symptoms and Impacts Questionnaire for Crohn’s Disease and Ulcerative Colitis (SIQ-CD and SIQ-UC, respectively) to address this need using guidelines recommended by the United States Food and Drug Administration and International Society for Pharmacoeconomics and Outcomes Research for the development of PROs. The SIQ-CD and SIQ-UC are also critically different from other PROs in that centrally-read endoscopy was used to qualify patients based upon a range of endoscopic disease activity during index development. These draft questionnaires are available for use in Crohn’s disease and ulcerative colitis clinical trials, and hold promise for evaluating IBD-related symptoms and impacts in patients with a range of clinical and endoscopic disease severity.

Development of a Radiological Index for Peri-Anal Crohn’s Disease

Perianal fistulas affect approximately one-third of patients with Crohn’s disease (CD) during their lifetime and are associated with considerable morbidity and impaired quality of life. Few clinical trials have specifically addressed fistula healing, thus identification of new treatments for fistulizing perianal CD is a large unmet clinical need. Magnetic resonance imaging (MRI) is the only modality capable of detecting/monitoring all manifestations of CD activity as well as transmural complications including perianal fistula. Although MRI is considered the gold standard for assessment of perianal fistulas, the lack of a validated outcome measure to assess disease activity and response to therapy was seen as a barrier to drug development. To address this need, we developed the Magnetic Resonance Novel Index for Fistula Imaging in CD (MAGNIFI-CD) using rigorous methods for index development. MAGNIFI-CD is a more reliable and responsiveness index compared to the commonly used Van Assche Index. The use of MAGNIFI-CD in future clinical trials will help facilitate research and development of novel therapies for a patient group with a large unmet need and burden of illness.

Our Research – Investment Outcomes That Benefit Patients And Clients

Outcome Development

Technological developments and advances in medical knowledge affect the evolution of how disease activity can and should be measured. In the clinical trial setting, decisions regarding the method, modality, and timing for assessment of disease activity have fundamental consequences on both trial efficiency and outcome.

In the current era, emphasis is further placed on the need for both objective disease measures as well as those that are relevant to patients. A contemporary dilemma facing trials in many disease areas, including gastrointestinal diseases, is the gap between this need and validated instruments that achieve these goals. Bridging this gap in inflammatory disease has involved a substantial research investment and has been a long-term academic focus at Alimentiv. We are pioneers in the development and validation of both the outcome measures and technology that are shaping the evolving clinical trial landscape for multiple indications.

We have created major research consortiums in collaboration with internationally recognized therapeutic experts, to identify disease-activity measures that are relevant to the underlying disease pathobiology, as well as those that are critical to patients. Together we are working towards standardizing and validating these measures as outcomes that will provide meaningful long-term consequences for patients, their treatment, and for society. Our findings are operationalized into superior clinical trial methodology for our clients that is in-line with emerging regulatory standards.

Our ongoing collaborative research is addressing unmet needs for numerous indications (Crohn’s disease [including pediatric and adult perianal fistulizing disease, as well as fibrostenosing and post-operative disease], ulcerative colitis [including pouchitis], eosinophilic esophagitis, non-alcoholic steatohepatitis) and is focused on multiple modalities (clinical, endoscopic, histologic, radiologic) for assessment, and the potential for development of core outcomes sets.

Investigator Initiated Studies

Research and Development that drives forward drug development and patient management in inflammatory bowel disease (IBD) is a hallmark that differentiates Alimentiv from other CROs. We tackle important clinical practice questions in IBD that can only be addressed by high-quality evidence from large scale randomized controlled trials. Our physician leaders and collaborators have successfully designed, conducted and executed investigator-initiated clinical trials funded through combinations of industry, charitable and peer-reviewed granting agencies. Some highlights of these endeavours are included below.

REACT (Randomized Evaluation of Algorithm for Crohn’s Disease Treatment) Trial

REACT (Principal Investigator: Dr. Brian Feagan), published in the Lancet in 2015, was a large-scale, cluster randomized trial conducted in 41 community practices throughout Canada and Belgium. The trial was funded by Abbvie, with Robarts Clinical Trials as the sponsor. Centers were randomly assigned to follow a treatment algorithm which involved either early combined immunosuppression for consecutive patients presenting with Crohn’s disease (CD) versus continuing with usual care. Although the trial did not find a difference between the two treatment strategies for a symptom-based outcome (Harvey-Bradshaw Index), there was a significant difference between the two treatment strategies after 24 months of follow-up for the outcomes of surgery, hospitalization and complications, providing real-world evidence in support of a treat-to-target approach in the management of patients with CD.

REACT-2 Trial

Poor correlation exists between clinical disease activity indices (which rely primarily on symptoms) and objective measures of intestinal inflammation such as endoscopy, and the objective measures are more predictive of disease course. Clinical practice is evolving to target endoscopic mucosal healing in addition to symptomatic improvement. REACT-2 (Co-principal Investigators: Drs. Brian Feagan and Vipul Jairath), a follow-on to REACT, is a cluster randomized trial conducted in Canada, USA, England and Germany, funded by Abbvie with Robarts Clinical Trials as the sponsor (https://clinicaltrials.gov/ct2/show/NCT01698307). The objective of the REACT-2 trial is to compare the effectiveness of an enhanced algorithm featuring early use of combination therapy with treatment initiation and intensification guided by resolution of endoscopic mucosal ulceration, to a more conventional step-care algorithm in the management of CD. The trial has completed recruitment and is in follow-up phase. Reporting of results is anticipated for early 2021.

VERDICT (In actiVE ulcerative colitis, a Randomized Controlled Trial for determination of the optimal treatment target)

Whilst endoscopic mucosal healing is accepted as the treatment goal in ulcerative colitis (UC), this treatment target is not “curative.” Disease relapse nevertheless occurs in patients who meet this outcome despite ongoing therapy. Importantly, histological disease activity persists in approximately one-quarter of patients with normal appearing mucosa and is associated with disease relapse. VERDICT (Principal Investigator: Dr. Vipul Jairath) is a collaborative clinical trial with Takeda pharmaceuticals, with Takeda as the funder and Robarts Clinical Trials as the sponsor (https://clinicaltrials.gov/ct2/show/NCT04259138). Randomization of 660 patients across 10 countries is planned. The primary objective of this trial is to determine whether a treatment target of corticosteroid-free symptomatic, endoscopic AND histological remission is superior to corticosteroid-free symptomatic remission alone for the primary endpoint of time to UC-related complication within 80 weeks of follow-up from achieving the treatment target in patients with moderately-to-severely active UC.

STATIC (STopping Aminosalicylate Therapy in Inactive Crohn’s Disease) Trial

Despite limited evidence for their benefit, aminosalicylates are used extensively as a treatment option for induction or maintenance of remission, or for prevention of postoperative recurrence, in patients with CD. STATIC (Principal Investigator: Dr. Vipul Jairath) is a large, simple, randomized, open-label, non-inferiority withdrawal trial. The study is funded by several peer-reviewed grants, with Robarts Clinical Trials as the sponsor (https://clinicaltrials.gov/ct2/show/NCT03261206). The trial is currently recruiting in Canada, England, Ukraine and Italy. Patients with CD in remission will be randomized in a 1:1 ratio to either continue or withdraw aminosalicylate therapy. The primary efficacy evaluation is the non-inferiority of continuing or withdrawing aminosalicylates on any CD‑related complication within 24 months of enrolment.

Our People

Delivering High-Value Research To Transform Human Health

Leading With Science

Our Medical Research and Development team are not just experts in the design and conduct of clinical trials. We identify barriers to drug development and pursue solutions that advance inflammatory bowel disease research.  Over the past five years Alimentiv has played a role in every drug that has been approved for IBD treatment through our Histopathology Index, Central Imaging Management Services and/or the involvement of our expert full service team.



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