Medical Director, IBD Research
Atlanta Gastroenterology Associates
Atlanta, Georgia

Douglas C. Wolf M.D. is Medical Director of IBD Research at Atlanta Gastroenterology Associates in Atlanta, GA. He is also Clinical Assistant Professor of Medicine, Emory University School of Medicine. Dr. Wolf is a graduate of Duke University and completed medical school and residency at West Virginia University School of Medicine. After GI fellowship at the Cleveland Clinic, he joined the faculty of Emory University School of Medicine, in Atlanta, and after 8 years, went into private practice. Over the past 25 years, Dr. Wolf has focused on Crohn’s disease and ulcerative colitis patient care. He has been treating patients with IBD at Atlanta Gastroenterology Associates for the past 19 years. Dr. Wolf has served as a Principal Investigator on many Crohn’s disease and ulcerative colitis clinical trials over the past 15 years. He is a co-author on over a dozen articles related to new treatments in Crohn’s disease and ulcerative colitis. Dr. Wolf has served as Chairman of the Professional Education Committee of CCFA and currently serves as Co-chair of the Industry and Government Relations (Advocacy) Committee of CCFA. Dr. Wolf is a reviewer and a Section Editor of the IBD journal. His current focus is the evaluation and use of new treatment options in Crohn’s disease and ulcerative colitis.

Atlanta Gastroenterology Associates

As the premier gastroenterology practice in the southeast, Atlanta Gastroenterology Associates’ physicians offer the knowledge and experience valued by patients who are suffering from digestive problems and liver disease. From the most common stomach ailments to the most serious gastrointestinal issues, our Board Certified specialists are highly skilled in evaluating and treating every type of liver and digestive disorder, as well as the detection and treatment of colon cancer.

Established more than 35 years ago, AGA has grown from two physicians to nearly 70 and from one office in Atlanta to 33 locations throughout the metropolitan area and North Georgia. In addition, the practice operates seven state-of-the-art Endoscopy Centers where most outpatient gastrointestinal procedures are performed. For patients who may require hospitalization, our physicians have privileges at most Atlanta-area hospitals.

At Atlanta Gastroenterology Associates, we are committed to providing our patients with the most appropriate and cost-effective healthcare available in a comfortable and compassionate setting. Our staff is specially trained to coordinate patient care and ensure that all medical needs are met, making our practice the right choice for those with digestive problems.

 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)

 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)