Miguel Regueiro, MD
University of Pittsburgh School of Medicine
Pittsburgh, PA

Professor of Medicine
University of Pittsburgh School of Medicine
Associate Chief for Education
Clinical Head and Co-Director, Inflammatory Bowel Disease Center
Head, IBD Clinical Program
Director, Gastroenterology Fellowship Program

Dr. Regueiro is the Head of the Clinical Inflammatory Bowel Disease Center. As such, he maintains an active IBD practice of over 2,000 patients. He has developed a prospective registry that phenotypes patients with Crohn's disease and ulcerative colitis. He has been involved in several clinical research trials in IBD. He has researched and published extensively on the management and prevention of postoperative Crohn's disease. He is actively involved in national IBD conferences and serves as associate editor, reviewer and faculty for GI courses and journals. Dr. Regueiro is also the director of the gastroenterology, hepatology and nutrition fellowship training program.

University of Pittsburgh
Inflammatory Bowel Disease Center

The University of Pittsburgh Medical Center's Inflammatory Bowel Disease Center provides specialized care for patients with ulcerative colitis and Crohn's dsease, contributes to the advancement of IBD research, and educates patients and healthcare professionals about IBD.

The IBD Center utilizes a cohesive team of physicians and surgeons, who are recognized as experts in their respective specialties. Directed by gastroenterologists who unite surgeons, nutritionists, radiologists and pathologists, the Center is designed to attract and care for a large volume of patients with IBD. In addition to providing comprehensive primary care to these patients, specific attention is also directed to cancer surveillance, women's health, intestinal rehabilitation and transplantation medicine, mental health and the transition of care from the pediatric to adult gastroenterologist. As such, care of IBD patients is integrated with the Pittsburgh Cancer Institute, Magee Women's Hospital, The Thomas E. Starzl Transplantation Institute, Western Psychiatric Institute and Clinic and Children's Hospital. By coordinating care across a variety of specialties and by providing IBD patients with "one stop shopping" for expert consultations and excellent diagnostic techniques, the Center continues to attract increasingly larger numbers of patients from the tri-state area.

The IBD Center physicians direct several multi-center, international research trials on novel IBD treatments and are respected as authorities in genetics, immunology and clinical research. Patients benefit from research advancements made by IBD Center physicians, who are some of the world's leading IBD genetics and immunology researchers.
• The IBD Center is one of six centers in the USA and Canada selected for the National Institutes of Health (NIH)/National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) IBD Genetics Consortium.
• As part of the University of Pittsburgh Autoimmunity Center of Excellence, which is one of the nine national centers also designated by the NIDDK to learn more about IBD immunology, the IBD Center offers the latest immunologic therapies that may have greater success and fewer side effects than traditional therapies.
• The IBD Center also identifies patients who have not responded to traditional therapies and recommends them for phase I and phase II pharmaceutical trials. The IBD Center has been involved in most major clinical studies of new compounds.
• The UPMC IBD center is one of a select group of IBD programs to host a Crohn’s & Colitis Foundation of American (CCFA) fellowship and preceptor. These rotations provide physician exposure to IBD in a tertiary referral center and are unique opportunities for gastroenterology fellows and community practitioners.

 Prevention and treatment of postoperative Crohn's disease recurrence: an update for a new decade.

 Physician assessment of ulcerative colitis activity correlates poorly with endoscopic disease activity.

 Crohn's disease activity index does not correlate with endoscopic recurrence one year after ileocolonic resection.

 Genome-wide meta-analysis increases to 71 the number of confirmed Crohn's disease susceptibility loci.

 Small bowel resection rates in Crohn's disease and the indication for surgery over time: experience from a large tertiary care center.

 Postoperative Crohn's disease: prevention and treatment.

 Phenotypic and genotypic characteristics of inflammatory bowel disease in French Canadians: comparison with a large North American repository.

 Infliximab prevents Crohn's disease recurrence after ileal resection.

 Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis (Merit-UC)

There are fewer therapeutic options for patients with active ulcerative colitis (UC) compared to patients with active Crohn's disease (CD) and the investigators are facing a persistent unmet need for additional effective and affordable therapies for patients with UC. Methotrexate (MTX) 25 mg once weekly administered subcutaneously (sq) or intramuscularly (im) is an efficient therapy to induce and maintain steroid free remission in patients with CD. To evaluate the efficacy of a similar approach in patients with active ulcerative colitis the investigators conduct a double-blind, placebo controlled, randomized, multicenter, parallel group trial to investigate the safety and efficacy of 25 mg MTX applied subcutaneously once weekly in patients with active UC, who either failed 5-ASA therapy, or are steroid dependent or are intolerant or not responding to azathioprine/6-mercaptopurine therapy or have no response/ lost response to infliximab prior to the study inclusion. The study is designed as a drug withdrawal trial and includes two periods, the Induction Period (week 0-16) and the Maintenance Period (week 17-48). In the open label Induction Period every patient will receive a steroid taper, MTX 25 mg sq once weekly + daily folic acid 1 mg tablets for the induction of clinical response or remission. Patients responding to the open label MTX therapy and being off steroids between week 12-16 will be randomized at week 16 1:1 to Placebo sq once weekly + daily folic acid 1 mg tablets + 2.4 g mesalamine or to MTX 25 mg sq once weekly + daily folic acid 1 mg tablets+ 2.4 g mesalamine. The Specific Aims of the trial are: i) To evaluate the safety and tolerability of 25 mg MTX applied sq once weekly over a time period of 48 weeks; ii) To evaluate the relapse-free survival of MTX maintenance therapy compared to placebo over a time period of 32 weeks; iii) To evaluate the efficacy of MTX over a time period of 16 weeks to induce steroid free remission; iiii) To establish a DNA, plasma and serum library to enable the evaluation of clinical and pharmacogenomic models to predict the response to MTX therapy in patients with UC. With 25-30 participating centers actively enrolling, the investigators anticipate to complete enrollment for this study in a time period of 3 years. Completion of this trial will define the therapeutic value of MTX in UC, potentially changing the current therapeutic strategy in UC.

PRIMARY OUTCOME MEASURES:
• Relapse free survival [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] Relapse-free survival, comprised of three components: total week 32 Mayo score not exceeding 2 points, with all individual subscores not exceeding 1 point and relapse free survival defined by a numerical stable Mayo score throughout 32 weeks of maintenance therapy without increase of 3 or more points in the partial Mayo clinic score (excluding sigmoidoscopy) compared to the partial Mayo score of the individual patient at randomization at week 16 (2) and no steroid use or other immunosuppressive medication throughout the 32 week maintenance period.

SECONDARY OUTCOME MEASURES:
• Mucosal healing defined as an absolute subscore for endoscopy of 0 or 1 at week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
• Relapse of disease [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] Relapse of disease in the Maintenance period as defined as an increase of 3 or more points in the partial Mayo clinic score (excluding sigmoidoscopy) with an absolute clinical Mayo score = 4 or need for retreatment with steroids.

Estimated Enrollment: 220
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study: 18 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

 Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

The purpose of this study is to determine if either a targeted type of talk therapy (Phase I) or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals with Inflammatory Bowel Disease (IBD).

Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

 Evaluating a Shared Decision Making Program for Crohn's Disease

Specific Aim: Study the impact of the Crohn's Disease Shared Decision Making Program on patients' treatment choice, persistence with chosen therapy, decision quality, cost of care, and outcomes

Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand which treatments are right for them and will lead to a higher acceptance of appropriate therapy, improved persistence with chosen therapy, lower costs and improved clinical outcomes.

To accomplish this aim, Investigators will perform a randomized controlled trial to:

Determine how the shared decision making program influences patients' choice of therapy
Evaluate how the shared decision making program affects persistence with chosen therapy
Determine how the shared decision making program affects decision quality
Determine how the shared decision making program influences cost of care and clinical outcomes

Expected Outcome and Impact: Investigators expect that this program will influence patients' choice of therapy, persistence with their preferred therapy, and lead to improved clinical outcomes. Investigators believe that this product can be successfully operationalized in the clinic to establish a new paradigm of how providers can communicate personalized treatment options to patients across a broad range of diseases.

Estimated Enrollment: 300
Study Start Date: March 2014
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

    Webcasts

    Mechanistic Approaches to IBD: Current & Future Management Strategies

    Stephen B. Hanauer, MD (chair), Gary R. Lichtenstein, MD, David G. Binion, MD, William Sandborn, MD, Corey A. Siegel, MD

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    Precision Medicine & Novel Therapeutics

    Maria T. Abreu, MD, David G. Binion, MD, Stephen B. Hanauer, MD, Gary R. Lichtenstein, MD, Eduardo V. Loftus JR., MD

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    Xpert Perspectives from DDW 2015: Reporting on IBD

    Stephen Hanauer, MD, Maria Abreu, MD, Gary Lichtenstein, MD

    Didactic Lecture

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    Update on IBD

    Raymond Cross, MD

    Didactic Lecture

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    Non-Digestive Neoplasms in IBD

    Edward Loftus, MD

    Didactic Lecture

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    Optimizing Therapies for Severe Ulcerative Colitis

    Ellen Scherl, MD

    Didactic Lecture

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    Epidemiology of IBD

    Edward Loftus, MD

    Didactic Lecture

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    Gi Summit 2014

    Stephen Hanauer, MD and Philip Schoenfeld, MD

    Didactic Lecture

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    Xpert Perspectives from DDW 2014: Reporting on IBD

    Stephen Hanauer, MD, Maria Abreu, MD, Amar Deshpande, MD, Gary Lichtenstein, MD

    Didactic Lecture

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    Xpert Perspectives from DDW - Reporting on IBD

    Maria T. Abreu, MD, Stephen B. Hanauer, MD, Scot Plevy, MD

    Didactic Lecture

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    eMonograph

    Expert Perspectives in the Management of Inflammatory Bowel Disease (IBD): A Review of Recent Advances

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    Advances in IBD

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    Optimizing the Management of Inflammatory Bowel Disease

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    Update in the Medical Management of Ulcerative Colitis: 2011

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    Webcasts

    Mechanistic Approaches to IBD: Current & Future Management Strategies

    Stephen B. Hanauer, MD (chair), Gary R. Lichtenstein, MD, David G. Binion, MD, William Sandborn, MD, Corey A. Siegel, MD

    Didactic Lecture

    view details >

    Precision Medicine & Novel Therapeutics

    Maria T. Abreu, MD, David G. Binion, MD, Stephen B. Hanauer, MD, Gary R. Lichtenstein, MD, Eduardo V. Loftus JR., MD

    Didactic Lecture

    view details >

    Xpert Perspectives from DDW 2015: Reporting on IBD

    Stephen Hanauer, MD, Maria Abreu, MD, Gary Lichtenstein, MD

    Didactic Lecture

    view details >

    Update on IBD

    Raymond Cross, MD

    Didactic Lecture

    view details >

    Non-Digestive Neoplasms in IBD

    Edward Loftus, MD

    Didactic Lecture

    view details >

    Optimizing Therapies for Severe Ulcerative Colitis

    Ellen Scherl, MD

    Didactic Lecture

    view details >

    Epidemiology of IBD

    Edward Loftus, MD

    Didactic Lecture

    view details >

    Gi Summit 2014

    Stephen Hanauer, MD and Philip Schoenfeld, MD

    Didactic Lecture

    view details >

    Xpert Perspectives from DDW 2014: Reporting on IBD

    Stephen Hanauer, MD, Maria Abreu, MD, Amar Deshpande, MD, Gary Lichtenstein, MD

    Didactic Lecture

    view details >

    Xpert Perspectives from DDW - Reporting on IBD

    Maria T. Abreu, MD, Stephen B. Hanauer, MD, Scot Plevy, MD

    Didactic Lecture

    view details >

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