Title: Professor of Medicine

Medical School
University of Pennsylvania, Philadelphia, PA

Residency
Temple University Health Sciences Center, Philadelphia, PA

Fellowship
Mayo Graduate School of Medicine, Mayo Clinic, Rochester, MN

Certifications
American Board of Internal Medicine - Internal Medicine
American Board of Internal Medicine - Gastroenterology

Interests
• Epidemiology of inflammatory bowel disease (Crohn's disease and ulcerative colitis)
• Natural history of inflammatory bowel disease
• Diagnosis and disease activity assessment of inflammatory bowel disease
• Medical therapy of inflammatory bowel disease
• Pharmacoeconomics of inflammatory bowel disease

Professional Highlights
• Editorial Board, Clinical Gastroenterology and Hepatology, 2009-present
• Associate Editor, Inflammatory Bowel Diseases, 2006-present
• Editorial Board, Gastroenterology, 2005-2010
• Associate Editor, American Journal of Gastroenterology, 2003-2009
• Physician of the Year Award, Crohn's and Colitis Foundation of America, Minnesota-Dakotas Chapter, 2008

Mayo Clinic in Rochester
200 First St. S.W.
Rochester, MN 55905
General Number: 507-284-2511

Gastroenterology and Hepatology at Mayo Clinic specializes in the prevention, diagnosis and treatment of diseases of the digestive tract and liver. It is the largest practice of its kind in the United States. In any given year, members of the Division perform approximately 30,000 minimally invasive, endoscopic procedures in state-of-the-art facilities.

Through a divisional infrastructure organized around interest groups oriented toward disease processes, organ systems, procedures or patient groups, clinical expertise is integrated with the newest forms of established and experimental diagnostic and therapeutic methods. Outpatients and patients in the hospital are cared for by teams of physicians and allied health personnel with broad expertise in all forms of gastroenterological and hepatobiliary diseases.

Because of our recognition that high-quality care depends upon scientific discovery, major research programs at the basic, applied, and translational levels exist to generate new knowledge that ultimately benefits patients.

Mayo Clinic in Rochester, Minn., ranks No. 1 for digestive disorders in the U.S. News & World Report Best Hospitals rankings. Mayo Clinic in Scottsdale, Ariz., and in Jacksonville, Fla., are ranked among the Best Hospitals for digestive disorders by U.S. News & World Report. Mayo Clinic also ranks among the Best Children's Hospitals for digestive disorders.

 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.

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)

 Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC. The cause of UC is not well understood. It is believed to be caused from an abnormal immune response to the normal bacteria that live in the gut (intestines and colon). This response acts as an "attack" on the healthy tissue of the bowel by a person's own immune cells which leads to disease. It is well known that autoimmune diseases such as IBD, asthma, diabetes, and multiple sclerosis are more common in industrialized, well-developed countries with better sanitation and hygiene, as in the United States. These "cleaner" environments reduce exposure to germs and parasites naturally found in the environment. This reduced exposure may trigger responses in the body that make people more prone to diseases such as UC. People in non-industrialized countries and the tropics, where parasites are common, rarely develop these diseases. This observation has led researchers to want to better understand the relationship between the lack of natural bacteria in the gut and the onset of autoimmune diseases like as UC.

Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)