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.
Publications:
Real-World multicentre observational study with Pop-PK modelling to evaluate the exposure-response relationship of vedolizumab in IBD
Brian Feagan, William Sandborn, Niels Vande Casteele.
CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease
Claire E Parker, Stefanie C McFarlane, Vipul Jairath, Geert D’Haens, Christopher Ma, Brian Feagan, William Sandborn, Niels Vande Casteele.
Heterogeneity in Efficacy and Safety Endpoints for Pediatric Clinical Trials in Inflammatory Bowel Disease: A Need for Harmonization
Placebo rates in randomized controlled trials of proctitis therapy: A systematic review and meta-analysis
Clinical, Endoscopic, and Safety Placebo Rates in Induction and Maintenance Trials of Crohn’s Disease: Meta-Analysis of Randomised Controlled Trials
Rocio Sedano, Christopher Ma, Geert D’Haens, Guangyong Zou, Brian Feagan, William Sandborn, Malcolm Hogan, Vipul Jairath, Eileen Crowley, Claire E Parker.
Comparison of the Relative Sensitivity of Clinical, Endoscopic, and Histologic Remission for Detection of Treatment Efficacy in Ulcerative Colitis Trials
Brian Feagan, Malcolm Hogan, Vipul Jairath, Rocio Sedano, Guangyong Zou, Christopher Ma.
Development and Validation of a Digital Analysis Method to Quantify CD3-immunostained T Lymphocytes in Whole Slide Images of Crohn’s Disease Biopsies
Guangyong Zou, Brian Feagan, Niels Vande Casteele, Vipul Jairath, Lisa M Shackelton, Stefanie C McFarlane.
Disease Activity Indices for Pouchitis: A Systematic Review
Vipul Jairath, William Sandborn, Lisa M Shackelton, Claire E Parker, Brian Feagan, Geert D’Haens, Rocio Sedano.
Reliability of histologic assessment for NAFLD and development of an expanded NAFLD activity score
Guangyong Zou, Rohit Loomba, Christopher Ma, Vipul Jairath, Brian Feagan.
The Relationship Between Endoscopic and Clinical Recurrence in Postoperative Crohn’s Disease: A Systematic Review and Meta-analysis
William Sandborn, Christopher Ma, Malcolm Hogan, Brian Feagan, Guangyong Zou, Rocio Sedano, Vipul Jairath.
Recommendations for standardizing biopsy acquisition and histological assessment of immune checkpoint inhibitor-associated colitis
Christopher Ma, Vipul Jairath, Brian Feagan.
Design of Clinical Trials for Mild to Moderate Crohn’s Disease
Christopher Ma, Vipul Jairath.
A nonparametric approach to confidence intervals for concordance index and difference between correlated indices
Guangyong Zou, Vipul Jairath.
Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis
William Sandborn, Niels Vande Casteele, Christopher Ma, Malcolm Hogan, Brian Feagan, Guangyong Zou, Geert D’Haens, Rocio Sedano, Eileen Crowley, Vipul Jairath.
Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease
Christopher Ma, Brian Feagan, Eileen Crowley, Vipul Jairath.
Sphingosine 1-phosphate modulation and immune cell trafficking in inflammatory bowel disease
ATRC, Niels Vande Casteele.
Similar Clinical Improvement Rates Among Biologic Drug Classes in Crohn’s Disease: Systematic Review and Meta-Regression
Guangyong Zou, Rocio Sedano, Christopher Ma, Vipul Jairath, Stefanie C McFarlane.
Responsiveness of Magnetic Resonance Enterography Indices for Evaluation of Luminal Disease Activity in Crohn’s Disease
Guangyong Zou, Jordi Rimola, Geert D’Haens, Christopher Ma, Vipul Jairath, Brian Feagan.
Reliability and responsiveness of endoscopic disease activity assessment in eosinophilic esophagitis
Malcolm Hogan, Julie Rémillard, Guangyong Zou, Arjan Bredenoord, Christopher Ma, Vipul Jairath, Brian Feagan, Evan Dellon.
Responsiveness of a Histologic Scoring System Compared With Peak Eosinophil Count in Eosinophilic Esophagitis
Christopher Ma, Evan Dellon, Brian Feagan, Lisa M Shackelton, Vipul Jairath, Guangyong Zou, Arjan Bredenoord, Stefanie C McFarlane.
Underrepresentation of Minorities and Lack of Race Reporting in Ulcerative Colitis Drug Development Clinical Trials
Vipul Jairath, Malcolm Hogan, Rocio Sedano, Christopher Ma.
Janus Kinase Inhibitors for the Management of Patients With Inflammatory Bowel Disease
Rocio Sedano, Christopher Ma, Vipul Jairath, Brian Feagan.
Design of Clinical Trials for Mild to Moderate Ulcerative Colitis
Vipul Jairath, Rocio Sedano.
A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn’s Disease
Brian Feagan, Niels Vande Casteele, Vipul Jairath, William Sandborn.
A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn’s Disease
Brian Feagan, Niels Vande Casteele, Vipul Jairath, Lisa M Shackelton, William Sandborn.
Systematic review: disease activity indices for immune checkpoint inhibitor-associated enterocolitis
Brian Feagan, Niels Vande Casteele, Vipul Jairath, Christopher Ma.
Underrepresentation of Minorities and Underreporting of Race and Ethnicity in Crohn’s Disease Clinical Trials
Christopher Ma, Malcolm Hogan, Rocio Sedano, Vipul Jairath.
Meta-analysis of gene expression disease signatures in colonic biopsy tissue from patients with ulcerative colitis
Niels Vande Casteele, Vipul Jairath, Guangyong Zou, Brian G Feagan.
Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS)
Evan Dellon, Christopher Ma, Arjan Bredenoord, Brian Feagan, Vipul Jairath.
An expert consensus to standardise the assessment of histological disease activity in Crohn’s disease clinical trials
Geert D’Haens, Vipul Jairath, Christopher Ma, Brian Feagan, William Sandborn.
Early Combined Immunosuppression May Be More Effective for Reducing Complications in Isolated Colonic- vs Ileal-Dominant Crohn Disease
Vipul Jairath, Brian Feagan, Guangyong Zou, William Sandborn.
Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn’s disease
Vipul Jairath, Brian Feagan.
Vedolizumab for the Treatment of Noninflammatory Bowel Disease Related Enteropathy
Christopher Ma, Vipul Jairath.
Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease
Christopher Ma, Vipul Jairath.
International consensus to standardise histopathological scoring for small bowel strictures in Crohn’s disease
Brian Feagan, William Sandborn, Vipul Jairath.
Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn’s Disease After Elective Surgery: Meta-Analysis
Christopher Ma, Vipul Jairath.
Vedolizumab and Extraintestinal Manifestations in Inflammatory Bowel Disease
Christopher Ma, Niels Vande Casteele, Brian Feagan, Vipul Jairath.
Impact of COVID-19 on Inflammatory Bowel Disease Clinical Trial Recruitment: A Global Survey of Principal Investigators
Vipul Jairath, Christopher Ma.
Methods for handling missing segments in Crohn’s disease clinical trials: analysis from the EXTEND trial
Brian Feagan, Vipul Jairath, Guangyong Zou, Christopher Ma.
Pharmacological Interventions for the Prevention and Treatment of Immune Checkpoint Inhibitor-Associated Enterocolitis: A Systematic Review
Niels Vande Casteele, Brian Feagan, Vipul Jairath, Christopher Ma.
A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus
Christopher Ma.
An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials
Vipul Jairath, Christopher Ma, William Sandborn, Niels Vande Casteele.
Publications – Systematic Review and Meta-Analysis
Geert D’Haens, Vipul Jairath, Christopher Ma, William Sandborn, Brian Feagan.
An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials
Vipul Jairath, William Sandborn, Brian Feagan.
Development and Validation of a Clinical Decision Support Tool That Incorporates Pharmacokinetic Data to Predict Endoscopic Healing in Patients Treated With Infliximab
Vipul Jairath, William Sandborn, Brian Feagan.
Reliability of the Endoscopic Ultrasound Ulcerative Colitis (EUS-UC) score for assessment of inflammation in patients with ulcerative colitis
Vipul Jairath.
Methods for handling missing segments in Crohn’s disease clinical trials: analysis from the EXTEND trial
Vipul Jairath, Christopher Ma, Guangyong Zou, Brian Feagan.
International consensus to standardise histopathological scoring for small bowel strictures in Crohn’s disease
Vipul Jairath, William Sandborn, Lisa M Shackelton, Claire E Parker, Brian Feagan.
A Systematic Review On Immune Checkpoint Inhibitor-Associated Enterocolitis
Christopher Ma, Brian Feagan, Niels Vande Casteele, Vipul Jairath.
Increased Risk of Infections with Anti-TNF Agents in Patients with Crohn’s Disease After Elective Surgery: Meta-Analysis
Vedolizumab for the Treatment of Noninflammatory Bowel Disease Related Enteropathy
Vipul Jairath, Christopher Ma.
Early Combined Immunosuppression Reduces Complications in Long-standing Crohn’s Disease: A Post Hoc Analysis of REACT
Brian Feagan, Vipul Jairath, William Sandborn, Christopher Ma, Guangyong Zou, Geert D’Haens.
Endoscopic Assessment of Inflammatory Bowel Disease Activity in Clinical Trials
Guangyong Zou, Christopher Ma, Brian Feagan, Niels Vande Casteele, Vipul Jairath.
Modeling Endoscopic Improvement after Induction Treatment With Mesalamine in Patients With Mild-to-Moderate Ulcerative Colitis
Geert D’Haens, Brian Feagan, Vipul Jairath, William Sandborn, Claire E Parker, Christopher Ma.
Precision Medicine in IBD Clinical Research
Niels Vande Casteele, Vipul Jairath.
Safety of Combination Biologic and Antirejection Therapy Post-Liver Transplantation in Patients With Inflammatory Bowel Disease
Brian Feagan, Christopher Ma, Vipul Jairath.
Clinical Trials of IL-12/IL-23 Inhibitors in Inflammatory Bowel Disease
Brian Feagan, Christopher Ma, Vipul Jairath.
Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid?
Christopher Ma, Vipul Jairath, William Sandborn, Brian Feagan.
Evaluating the optimum number of biopsies to assess histological inflammation in ulcerative colitis: a retrospective cohort study
Guangyong Zou, Vipul Jairath, Niels Vande Casteele, William Sandborn, Brian Feagan.
Alternative and Complementary Approaches for the Treatment of Inflammatory Bowel Disease: Evidence From Cochrane Reviews
Brian Feagan.
Response to Placebo, Measured by Endoscopic Evaluation of Crohn’s Disease Activity, in a Pooled Analysis of Data From 5 Randomized Controlled Induction Trials
Guangyong Zou, Vipul Jairath, Niels Vande Casteele, William Sandborn, Brian Feagan.
Development of the symptoms and impacts questionnaire for Crohn’s disease and ulcerative colitis
Vipul Jairath, William Sandborn, Brian Feagan, Christopher Ma.
Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis
Vipul Jairath, Niels Vande Casteele, William Sandborn, Brian Feagan.
Corticosteroid-Free Remission vs Overall Remission in Clinical Trials of Moderate-Severe Ulcerative Colitis and Crohn’s Disease
William Sandborn, Brian Feagan, Christopher Ma, Vipul Jairath.
Histopathology Scoring Systems of Stenosis Associated With Small Bowel Crohn’s Disease: A Systematic Review
Brian Feagan, Vipul Jairath.
Clinical Pharmacology of Janus Kinase Inhibitors in Inflammatory Bowel Disease
Niels Vande Casteele.
Systematic review: medical therapy for fibrostenosing Crohn’s disease
Brian Feagan, Christopher Ma, Vipul Jairath.
Reliability of Endoscopic Evaluation of Postoperative Recurrent Crohn’s Disease
Brian Feagan, William Sandborn, Geert D’Haens, Christopher Ma, Vipul Jairath, Guangyong Zou.
Modeling Endoscopic Improvements
Brian Feagan, William Sandborn, Geert D’Haens, Christopher Ma, Vipul Jairath.
Discordance Between Patient-Reported Outcomes and Mucosal Inflammation in Patients With Mild to Moderate Ulcerative Colitis
William Sandborn, Geert D’Haens, Christopher Ma, Vipul Jairath, Guangyong Zou, Brian Feagan.
Assessing National Trends and Disparities in Ambulatory, Emergency Department, and Inpatient Visits for Inflammatory Bowel Disease in the United States (2005-2016)
Christopher Ma, Vipul Jairath, Brian Feagan.
Biomarkers of Crohn’s Disease to Support the Development of New Therapeutic Interventions
Niels Vande Casteele.
Adalimumab for maintenance of remission in Crohn’s disease
Vipul Jairath, Brian Feagan.
ATRC Review: JAK-STAT pathway targeting for the treatment of IBD
Niels Vande Casteele.
Oral Janus kinase inhibitors for maintenance of remission in ulcerative colitis
Vipul Jairath.
Factors Influencing Drug Disposition of Monoclonal Antibodies in Inflammatory Bowel Disease: Implications for Personalized Medicine
Niels Vande Casteele.
Histologic Healing Rates of Medical Therapies for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Vipul Jairath, Brian Feagan, William Sandborn, Niels Vande Casteele.
Benefit-Risk Assessment of Vedolizumab in the Treatment of Crohn’s Disease and Ulcerative Colitis
Vipul Jairath, Christopher Ma, Brian Feagan.
Assessment of Crohn’s disease-associated small bowel strictures and fibrosis on cross-sectional imaging: a systematic review
Christopher Ma, Brian Feagan, Vipul Jairath.
Pharmacotherapies for the Treatment of Eosinophilic Esophagitis: State of the Art Review
Brian Feagan, Vipul Jairath, Christopher Ma.
Development and Validation of a Magnetic Resonance Index for Assessing Fistulas in Patients With Crohn’s Disease
Brian Feagan, William Sandborn, Vipul Jairath, Guangyong Zou.
Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial
Brian Feagan, William Sandborn, Vipul Jairath, Niels Vande Casteele, Guangyong Zou.
Identifying Outcomes in Clinical Trials of Pouchitis for the Development of a Core Outcome Set
Vipul Jairath, Christopher Ma, Brian Feagan.
Innovations in Oral Therapies for Inflammatory Bowel Disease
Vipul Jairath, William Sandborn, Christopher Ma, Brian Feagan.
What is the role of C-reactive protein and fecal calprotectin in evaluating Crohn’s disease activity?
Vipul Jairath, Christopher Ma, Brian Feagan.
Advances in Therapeutic Drug Monitoring for Small-Molecule and Biologic Therapies in Inflammatory Bowel Disease
Vipul Jairath, Christopher Ma, Niels Vande Casteele.
Update on C-reactive protein and fecal calprotectin: are they accurate measures of disease activity in Crohn’s disease?
Vipul Jairath, Christopher Ma, Brian Feagan.
Systematic review with meta-analysis: efficacy and safety of oral Janus kinase inhibitors for inflammatory bowel disease
Vipul Jairath, Christopher Ma, Brian Feagan, Niels Vande Casteele.
IL12/23 or selective IL23 inhibition for the management of moderate-to-severe Crohn’s disease?
Vipul Jairath, Christopher Ma, Brian Feagan.
Identifying Outcomes in Clinical Trials of Fistulizing Crohn’s Disease for the Development of a Core Outcome Set
Christopher Ma, Brian Feagan, Vipul Jairath.
Evaluation of optimal biopsy location for assessment of histological activity, transcriptomic and immunohistochemical analyses in patients with active Crohn’s disease
Brian Feagan, William Sandborn, Niels Vande Casteele, Geert D’Haens, Guangyong Zou, Vipul Jairath.
Definitions of response and remission for the Robarts Histopathology Index
Brian Feagan, William Sandborn, Niels Vande Casteele, Geert D’Haens, Vipul Jairath.
Standardising the interpretation of liver biopsies in non-alcoholic fatty liver disease clinical trials
Brian Feagan, Vipul Jairath.
Early combined immunosuppression may be effective and safe in older patients with Crohn’s disease: post hoc analysis of REACT
William Sandborn, Vipul Jairath, Guangyong Zou, Brian Feagan.
Infliximab Exposure-Response Relationship and Thresholds Associated With Endoscopic Healing in Patients With Ulcerative Colitis
William Sandborn, Niels Vande Casteele, Vipul Jairath, Brian Feagan.
A composite disease activity index for early drug development in ulcerative colitis: development and validation of the UC-100 score
Guangyong Zou, Vipul Jairath, William Sandborn, Brian Feagan, Geert D’Haens.
Evolution of the Randomized Controlled Trial in Inflammatory Bowel Disease: Current Challenges and Future Solutions
Guangyong Zou, Brian Feagan.
Additional Stability Testing of Cryopreserved Intestinal Biopsies for Downstream Flow Cytometric Analysis
Niels Vande Casteele.
2018 August Author Interview – Vipul Jairath
Vipul Jairath.
Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy
Brian Feagan, Christopher Ma, Vipul Jairath.
Physicians’ Perspectives on Cost, Safety, and Perceived Efficacy Determine Aminosalicylate Use in Crohn’s Disease
Vipul Jairath, Christopher Ma, Brian Feagan.
An expert consensus to standardise definitions, diagnosis and treatment targets for anti-fibrotic stricture therapies in Crohn’s disease
Christopher Ma, Vipul Jairath, Brian Feagan, William Sandborn.
Heterogeneity in Clinical, Endoscopic, and Histologic Outcome Measures and Placebo Response Rates in Clinical Trials of Eosinophilic Esophagitis: A Systematic Review
Brian Feagan, Vipul Jairath, Christopher Ma.
Evaluation of the effect of storage condition on cell extraction and flow cytometric analysis from intestinal biopsies
Niels Vande Casteele, Vipul Jairath, Brian Feagan.
Systematic review with meta-analysis: prevalence, risk factors and costs of aminosalicylate use in Crohn’s disease
Vipul Jairath, Christopher Ma, Brian Feagan.
Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set
Geert D’Haens, Brian Feagan, William Sandborn, Vipul Jairath, Christopher Ma.
Systematic review with meta-analysis: endoscopic and histologic placebo rates in induction and maintenance trials of ulcerative colitis
Brian Feagan, Niels Vande Casteele, William Sandborn, Vipul Jairath, Christopher Ma, Geert D’Haens.
Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis
Vipul Jairath, Geert D’Haens, Guangyong Zou, Brian Feagan, William Sandborn.
Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn’s Disease: A Systematic Review
Geert D’Haens, Brian Feagan, Niels Vande Casteele, William Sandborn, Vipul Jairath, Christopher Ma.
Novel Therapies and Treatment Strategies for Patients with Inflammatory Bowel Disease
William Sandborn, Brian Feagan, Geert D’Haens, Vipul Jairath, Niels Vande Casteele.
Reliability of histologic assessment in patients with eosinophilic oesophagitis
William Sandborn, Vipul Jairath, Geert D’Haens, Guangyong Zou, Brian Feagan.
Efficacy of Medical Therapies for Fistulizing Crohn’s Disease: Systematic Review and Meta-analysis
Vipul Jairath, Brian Feagan.
Development of Clinical Prediction Models for Surgery and Complications in Crohn’s Disease
William Sandborn, Brian Feagan, Vipul Jairath, Guangyong Zou.
Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis
Vipul Jairath, Guangyong Zou, Brian Feagan.
Reliability of Measuring Ileo-Colonic Disease Activity in Crohn’s Disease by Magnetic Resonance Enterography
Guangyong Zou, Vipul Jairath, William Sandborn, Brian Feagan, Geert D’Haens.
Disease activity indices in coeliac disease: systematic review and recommendations for clinical trials
William Sandborn, Brian Feagan, Geert D’Haens, Vipul Jairath.
The Expanding Therapeutic Armamentarium for Inflammatory Bowel Disease: How to Choose the Right Drug[s] for Our Patients?
Vipul Jairath, William Sandborn, Brian Feagan, Geert D’Haens, Niels Vande Casteele.
Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study
Vipul Jairath, Geert D’Haens, Niels Vande Casteele, Brian Feagan, William Sandborn.
Systematic Review: Disease Activity Indices in Eosinophilic Esophagitis
Vipul Jairath, Geert D’Haens, Brian Feagan, William Sandborn.
Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis
William Sandborn, Vipul Jairath, Guangyong Zou, Brian Feagan, Geert D’Haens.
Alicaforsen for the treatment of inflammatory bowel disease
Vipul Jairath, Brian Feagan.
Evolving Concepts in Phases I and II Drug Development for Crohn’s Disease
William Sandborn, Vipul Jairath, Brian Feagan, Geert D’Haens, Niels Vande Casteele.
Reliability of EUS indices to detect inflammation in ulcerative colitis
Vipul Jairath, Guangyong Zou, Brian Feagan.
Histologic scoring indices for evaluation of disease activity in Crohn’s disease
Vipul Jairath, Geert D’Haens, Brian Feagan, William Sandborn.
The development of a magnetic resonance imaging index for fistulising Crohn’s disease
Vipul Jairath, Geert D’Haens, Brian Feagan, William Sandborn, Guangyong Zou.
Pharmacokinetic drug evaluation of budesonide in the treatment of Crohn’s disease
Brian Feagan, Vipul Jairath.
Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey
Brian Feagan, Christopher Ma, William Sandborn, Vipul Jairath.
A comparison of approaches for adjudicating outcomes in clinical trials
Vipul Jairath, Brian Feagan.
Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis
Guangyong Zou, Geert D’Haens, Vipul Jairath, William Sandborn.
Histologic scoring indices for evaluation of disease activity in ulcerative colitis
Brian Feagan, Guangyong Zou, Vipul Jairath.
The Evolution of Treatment Paradigms in Crohn’s Disease: Beyond Better Drugs
Vipul Jairath, Brian Feagan.
Incidence, Prevention and Management of Anti-Drug Antibodies Against Therapeutic Antibodies in Inflammatory Bowel Disease: A Practical Overview
Brian Feagan, Vipul Jairath.
The safety of vedolizumab for the treatment of ulcerative colitis
Vipul Jairath, Brian Feagan.
Systematic review with meta-analysis: placebo rates in induction and maintenance trials of Crohn’s disease
William Sandborn, Vipul Jairath, Guangyong Zou, Brian Feagan, Geert D’Haens.
Development and validation of a histological index for UC
Geert D’Haens, Brian Feagan, William Sandborn, Guangyong Zou, Vipul Jairath.
Review article: dose optimisation of infliximab for acute severe ulcerative colitis
Brian Feagan, Geert D’Haens, Vipul Jairath, William Sandborn.
Responsiveness of Endoscopic Indices of Disease Activity for Crohn’s Disease
William Sandborn, Guangyong Zou, Vipul Jairath, Geert D’Haens, Brian Feagan.
Effect of Standardised Scoring Conventions on Inter-rater Reliability in the Endoscopic Evaluation of Crohn’s Disease
Guangyong Zou, Brian Feagan, Geert D’Haens, William Sandborn.
Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis
William Sandborn, Guangyong Zou, Brian Feagan, Vipul Jairath, Geert D’Haens.
Assessment of histologic disease activity in Crohn’s disease: a systematic review
William Sandborn, Geert D’Haens.
Reproducibility of histological assessments of disease activity in UC
William Sandborn, Guangyong Zou, Geert D’Haens.
A prospective cohort study to determine the relationship between serum infliximab concentration and efficacy in patients with luminal Crohn’s disease
Brian Feagan.
Histologic evaluation of ulcerative colitis: a systematic review of disease activity indices
William Sandborn, Brian Feagan, Geert D’Haens.
The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis
Guangyong Zou, Geert D’Haens.