Research

Physicians in the University of Maryland Medical Center's Inflammatory Bowel Disease (IBD) Program are actively involved in clinical research. For more information about current clinical trials or past publications, please click on the links below.

Clinical Trials

The UMB IBD program is a member of the Clinical Research Alliance of the Crohn's and Colitis Foundation of America. Currently, the UM IBD program offers the following clinical research studies for patients to participate in:

TELEmedicine in Patients with Inflammatory Bowel Disease: TELE-IBD

The goals of this study are evaluate the impact of a home telemedicine system for patients with inflammatory bowel disease on disease activity, quality of life, and utilization of health care resources compared to best available care.

Status: Recruiting

For further information, please click here or call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

The Impact of Medical Treatment on Sexual Function in Patients with Crohn’s Disease

The goals of this study are compare the impact of different treatments for Crohn’s disease on short and long-term sexual function.

Status: Recruiting

For more information, please call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

CTRC-Randomized Double Blind Prospective Trial Investigating the Efficacy of Methotrexate in Induction and Maintenance of Steroid-Free Remission in Ulcerative Colitis.

The goals of this study are to evaluate the effectiveness of methotrexate for the treatment of ulcerative colitis.

Status: Recruiting

For further information, please click here or call the principal investigator Mark Flasar, M.D., M.S., at 410-706-3387.

Gene Discoveries in Subjects with Crohn's Disease of African Descent

The goal of this study is to perform genetic studies to better understand the differences between African Americans and Caucasians with inflammatory bowel disease 

Status: Recruiting

For more information, please call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

Crohn’s Shared Decision Making Program

The goals of this study are to develop a decision aid that incorporates information on long-term prognosis and study it’s impact on patients’ choices regarding treatment and clinical outcomes.

Status: Recruiting

For more information, please click here (https://www.clinicaltrials.gov/ct2/show/NCT02084290?term=corey+siegel&rank=1), or call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

Does Mucosal Healing Matter for Clinically Quiescent Ulcerative Colitis?

The goals of this study are determine the proportion of patients with ulcerative colits without symptoms that have inflammation present during colonoscopy.

Status: Recruiting

For more information, please call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

Prospective Cohort of Ulcerative Colitis and Crohn’s Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I

The goals of this study are to evaluate factors associated with adverse outcomes in patients with Crohn’s disease undergoing major abdominal surgery.

Status: Recruiting

For more information click here (https://clinicaltrials.gov/ct2/show/NCT02054533?term=puccini&rank=1) or please call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring

The goals of this study are to assess the long-term safety of Tysabri (natalizumab) in patients with moderate to severely active Crohn’s disease.

Status: Recruiting

For more information, please click here, or call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

SECURE: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia) for Crohn's Disease

The goals of this study are to assess the long-term safety of certolizumab pegol (Cimzia) for the treatment of Crohn’s disease.

Status: Recruiting

For more information, please click here (https://www.clinicaltrials.gov/ct2/show/NCT00844285?term=SECURE&rank=4), or call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

A Long-Term Registry of Humira (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

The goals of this study are to assess the long-term safety of Humira (adalimumab) in the treatment of moderate to severe ulcerative colitis.

Status: Recruiting

For more information click here (https://clinicaltrials.gov/ct2/show/NCT01848561?term=humira+uc&rank=1) or please call the principal investigator Mark Flasar, M.D., M.S., at 410-706-3387.

Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn’s Disease Subjects

The goals of this study are to evaluate the ability of video capsule endoscopy (pill camera) to monitor disease activity in patients with Crohn’s disease.

Status: Recruiting

For more information click here (https://clinicaltrials.gov/ct2/show/NCT01942720?term=capsule+endoscopy+crohn%27s+disease&rank=13) or please call the principal investigator Leyla Ghazi, M.D., at 410-706-3387.

603: A Phase III, multicenter, placebo-controlled, randomized, double-blind study to evaluate the safety and efficacy of PROCHYMAL® (ex vivo cultured adult human mesenchymal stem cells)) intravenous infusion for the induction of remission in subjects experiencing treatment-refractory moderate-to-severe Crohn’s disease.

The goals of this study are to evaluate the effectiveness of stem cell (PROCHYMAL) infusions in the treatment of patients with moderate to severe Crohn’s disease.

Status: Not currently recruiting

For more information, please click here or call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

611: A Multicenter, open-label study to evaluate the safety of PROCHYMAL® (remestemcel-L) intravenous infusion in subjects who have received previous remestemcel-L induction treatment for treatment-refractory moderate-to-severe Crohn’s disease.

The goals of this study are to evaluate the effectiveness of stem cell (PROCHYMAL) infusions in the treatment of patients with moderate to severe Crohn’s disease.

Status: Not currently recruiting

For further information, please click here or call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

A 5-Year, Registry Study of Humira (Adalimumab) in Patients with Moderately to Severely Active Crohn's Disease (CD)

The goals of this study are to assess the long-term safety of Humira (adalimumab) in Patients with moderate to severely active Crohn’s disease.

Status: Not currently recruiting

For more information, please click here, or call the principal investigator Mark Flasar, M.D., M.D., at 410-706-3397.

Autoimmune Paradoxical Reactions in IBD Longitudinal Cohort (April Cohort)

The goals of this study is to identify and better understand adverse reactions to anti-TNF agents such as infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).

Status: Not recruiting

For more information, please call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease

The goals of this study are to evaluate the effectiveness and safety of vedolizumab for the treatment of ulcerative colitis and Crohn’s disease.

Status: Not recruiting

For more information click here (https://clinicaltrials.gov/ct2/show/NCT00790933?term=vedolizumab&rank=12) or please call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease (IMUNITI)

The goals of this study are to evaluate the effectiveness and safety of ustekinumab for the treatment of moderate to severely active Crohn’s disease.

Status: Not recruiting

For more information click here (https://clinicaltrials.gov/ct2/show/NCT01369355?term=ustekinumab&rank=10) or please call the principal investigator Mark Flasar, M.D., M.S., at 410-706-3387.

Utility of Video Capsule Endoscopy Compared to Ileocolonoscopy in the Evaluation of Endoscopic Recurrence of Post-Operative Crohn’s Disease: A Pilot Study.

The goals of this study are to assess the ability of video capsule endoscopy (pill camera) to detect recurrence of Crohn’s disease after surgery.

Status: Not recruiting

For more information please call the principal investigator Mark Flasar, M.D., M.S., at 410-706-3387.

Treatment of Crohn’s Disease with an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis

The goals of this study are to compare the effectiveness of antibiotics directed against the bacteria Mycobacterium avium paratuberculosis on clinical outcomes in patients with Crohn’s disease.

Status: Not recruiting

For more information click here (https://clinicaltrials.gov/ct2/show/NCT00513552?term=mycobacterium+paratuberculosis&rank=1) or please call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC-1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

The goals of this study are to evaluate the effectiveness of RPC-1063 for the treatment of moderate to severe ulcerative colitis.

Status: Not recruiting

For more information click here (https://clinicaltrials.gov/ct2/show/NCT01647516?term=rpc-1063&rank=4) or please call the principal investigator Raymond Cross, M.D., M.S., at 410-706-3387.

We are also actively involved in a number of other research projects, including but not limited to:

  • Disparities in Treatment in Patients with Inflammatory Bowel Disease
  • Racial Differences in Disease Activity and Quality of Life in Patients with Inflammatory Bowel Disease
  • Do Anti-TNF agents increase the risk of complications after abdominal surgery?
  • Are Anti-TNF Agents Radiation-Sparing in Patients with Crohn's Disease?
  • What are the Risk Factors for Progression to Complicated Crohn's disease and Disability?
  • Differences in Serologic Expression to Microbial Antigens between Young and Older Patients with Crohn's Disease
  • What are the risk factors for vitamin D deficiency and impact of replacement on disease activity and quality of life in Inflmmatory Bowel Disease?
  • What is the prevalence of sexual dysfunction and distorted body image in patients with Inflammatory Bowel Disease?
  • What is the impact of medical treatment on sexual function and body image in Inflammatory Bowel Disease?
  • What are the risk factors for chronic narcotic use in patients with Inflammatory Bowel Disease?
  • What is the accuracy of magnetic resonance imaging compared to operative and endoscopic findings in patients with Crohn's disease?
  • Does fecal bacterial populations correlated with complicated Crohn's disease and recurrence after surgery?

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Publications

  1. Cross RK, Wilson KT, Binion DG. Polypharmacy and Crohn's disease. Aliment Pharmacol Ther 2005;21:1211-6

  2. Cross RK, Wilson KT, Binion DG. Narcotic use in patients with Crohn's disease. Am J Gastroenterol 2005;100(10):2225-9.

  3. Cross RK, Arora M, Finkelstein J. Acceptance of telemanagement is high in patients with inflammatory bowel disease. J Clin Gastroenterol 2006;40(3):200-8.

  4. Cross RK, Jung C, Wasan S, Joshi G, Sawyer R, Roghmann MC. Racial Differences in Disease Phenotypes in Patients With Crohn's Disease. Inflamm Bowel Dis 2006;12(3):192-198.

  5. Castro, HK, Cross, RK, and Finkelstein, J. Using a Home Automated Telemanagement System (HAT): Experiences and Perceptions in Patients with Inflammatory Bowel Disease. AMIA Annu Symp Proc 2006;872.

  6. Cross, RK, and Finkelstein, J. Feasibility and Acceptance of a Home Telemanagement System in Patients with Inflammatory Bowel Disease: A 6-Month Pilot Study. Dig Dis Sci 2007;52(2):357-364.

  7. Donovan, M, Lunney, K, Carter-Pokras, O, and Cross, RK. Prescribing Patterns and Awareness of Adverse Effects of Infliximab: A Health Survey of Gastroenterologists. Dig Dis Sci. Aug 2007;52(8):1798-1805.

  8. Dunnigan, M, Yfantis, H, Rapoport, AP, Hosseinzadeh, K, Gocke, CD, and Cross, RK. Large cell lymphoma presenting as a flare of colitis in a patient with common variable immune deficiency. Dig Dis Sci. 2007;52(3):830-4.

  9. Cross, RK, Lapshin, O, and Finkelstein, J. Patient Subjective Assessment of Drug Side Effects in Inflammatory Bowel Disease. J Clin Gastroenterol. 2008;42(3):244-51

  10. Flasar MH, Johnson T, Roghmann MC, Cross RK. Disparities in the use of immunomodulators and biologics for the treatment of inflammatory bowel disease: A retrospective cohort study. Inflamm Bowel Dis. 2008;14(1):13-9

  11. Flasar, M, Quezada, S, Bijpuria, P, Wu, Roger, and Cross, RK. Racial Differences in Extent, Severity, and Extraintestinal Manifestations in Patients with Ulcerative Colitis: A Retrospective Cohort Study. Dig Dis Sci. 2008;53(10):2754-2760

  12. Greenberg, R, Greenwald, B, Ioffe, O, Roth, S, and Cross, RK. Squamous Dysplasia of the Rectum in a Patient with Ulcerative Colitis Treated with 6-Mercaptopurine. Dig Dis Sci. 2008;53(3):760-4.

  13. Cross, RK. Another Anti-TNF Therapy for Patients with Crohn’s Disease (Summary of Schreiber, S, Khaliq-Kareemi, M, Lawrance, IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s Disease. N Eng J Med. 2007;357:239-250). Inflamm Bowel Dis. 2008;14(3):425-427.

  14. Warren, JW, Howard, FM, Cross, RK, Good, J, Weissman, M, Wesselmann, U,  Langenberg, P, Greenberg, P, and Clauw, D. “Antecedent non-bladder syndromes in a case control study of interstitial cystitis/painful bladder syndrome”. Urology. 2009;73(1):52-7.

  15. Quezada, S, Turner, P, Alexiev, B, Daly, B, and Cross, RK. “Severe Refractory Orofacial Crohn’s Disease: Report of a Case”. Dig Dis Sci 2009;54(10):2290-5.

  16. Cross RK, Cheevers N, Finkelstein J. Home Telemanagement for Patients with Ulcerative Colitis (UC HAT). Dig Dis Sci 2009;54(11):2463-2472.

  17. St. Charles, M, Weiss Smith, SR, Beardsley, R, Fedder, DO, Carter-Pokras, O, and Cross, RK. Gastroenterologists Prescribing of Infliximab: A National Survey. Inflamm Bowel Dis. 2009;15(10)1467-75.

  18. Cross R, Finkelstein J. Challenges in the design of a Home Telemanagement Trial for patients with ulcerative colitis. Clin Trials 2009;6(6)649-57.

  19. Ghazi, L and Cross, RK. Fever of Unknown Origin in an Immune Suppressed Patient with Crohn’s Disease: An Unusual Cause. Practical Gastroenterology 2010;34(11):42-46.

  20. Samimi, R, Flasar, MH, Kavic, S, Tracy, K, and Cross, RK. Outcome of Medical Treatment of Stricturing and Penetrating Crohn’s Disease: A Retrospective Study. Inflamm Bowel Dis. 2010;16(7):1187-1194.

  21. Cross, RK, Cheevers, N, Rustgi, A, Langenberg, P, and Finkelstein, J. A Randomized, Controlled Trial of Home Telemanagement in Patients with Ulcerative Colitis (UC HAT). Inflamm Bowel Dis 2012;18(6):1018-1025.

  22. Cross, RK. Application of Telemedicine for Inflammatory Bowel Disease: Review of the Literature and Future Implications. J Gastrointest Digest Sys. October 2011;1(e102).

  23. Flasar, MH, Cross, RK, and Doman, DB. Current and Future Role of Ulcerative Colitis Serogenomics. Gastroenterology and Hepatology. November 2011;7(11):720-727.

  24. Patil, SA, Rustgi, A, Quezada, SM, Flasar, MH, Vandermeer, F, and Cross RK. Anti-TNF Therapy is Associated with Decreased Imaging and Radiation Exposure in Patients with Crohn’s Disease. Inflamm Bowel Dis. 2013;19(1):92-98.

  25. Quezada, SM and Cross, RK. Association of Age at Diagnosis and Ulcerative Colitis Phenotype. Dig Dis Sci. 2012;57(9):2402-2407.

  26. Faust, AH, Halpern, LF, Danoff-Burg, S, and Cross, RK. Psychosocial Factors Contributing to Inflammatory Bowel Disease Activity and Health-Related Quality of Life. Gastroenterology & Hepatology. March 2012;8(3):1-9.

  27. McLean, LP, Shea-Donahue, T, and Cross, RK. Vedolizumab for the Treatment of Ulcerative Colitis and Crohn’s Disease. Immunotherapy. 2012;4(9):883-898.

  28. Patil, S and Cross, RK. Where We’re Going, We Don’t Need Appointments: the Future of Telemedicine in IBD. (Summary of Krier, M, Kaltenbach, T, McQuaid, K, et al. Potential Us of telemedicine to provide outpatient care for inflammatory bowel disease. Am J Gastroenterol. 2011;106:2063-7). Inflamm Bowel Dis. 2012;18(11):2199-2200.

  29. Quezada, SM, Steinberger, EK, and Cross, RK. Association of Age at Diagnosis and Crohn’s Disease Phenotype.  Age Ageing. August 2012;0:1-4.

  30. Patil, SA, Rustgi, A, Langenberg, P, and Cross, RK. Comparative Effectiveness of Anti-TNF Agents for Crohn’s Disease in a Tertiary Referral IBD Practice. Dig Dis Sci. 2013;58(1):209-215.

  31. Ghazi, LJ, Patil, SA, Rustgi, A, Flasar, MH, Razeghi, S, and Cross, RK. Step Up versus Early Biologic Therapy for Crohn’s Disease in Clinical Practice. Inflamm Bowel Dis. 2013;19(7):1397-1403.

  32. Syed, A, Cross, RK, and Flasar, MH. Anti-Tumor Necrosis Factor Therapy is Associated with Infections after Abdominal Surgery in Crohn’s Disease Patients. Am J Gastroenterol. 2013;108(4):583-593.

  33. Quezada, SM and Cross, RK. To Yeast or Not to Yeast: A Probiotic Question. (Summary of Bourreille, A, Cadiot, G, Le Dreau, G, et al. Saccharomyces Boulardii for the Prevention of Relapse in Crohn’s Disease: Results of a Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial. Clin Gastroenterol Hepatol). Clin Gastroenterol Hepatol. 2013;11(8): 988-990.

  34. McLean, LP, Cross, RK, and Shea-Donohue, T. Combined Blockade of IL-17A and IL-17F Prevents the Development of Experimental Colitis. (Summary of Wedebye Schmidt, EG, Larsen, HL, Kristensen, N et al. TH17 Cell Induction and Effects of IL-17A and IL-17F Blockade in Experimental Colitis. Inflamm Bowel Dis). Immunotherapy. 2013;5(9):1-3.

  35. Razeghi, S, Halvorson, CR, Gaspari, AA, and Cross, RK. Successful Treatment of Localized Pyoderma Faciale in a Patient with Crohn’s Disease. Gastroenterology & Hepatology. 2013;9(8):541-544.

  36. Cheng, FF, McLean, LP, and Cross, RK. What is the Role of Vedolizumab in the Era of Anti-TNF Agents. (Summary of Sandborn, WJ, Feagan, BG, and Rutgeerts, P et al. Vedolizumab as Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med). Ann Transl Med. 2014;2(1):1-4.

  37. McLean, LP, Chun, J, and Cross, RK. “Right Lower Quadrant Pain in a Patient with IBD of Undetermined Type”. Clin Gastroenterol and Hepatol. 2014;12(4):A29-30.

  38. McLean, LP and Cross, RK. “Adverse Events in IBD: To Stop or Continue Immune Suppressant and Biologic Treatment”. Expert Rev Gastroenterol Hepatol. 2014;8(3):223-240.

  39. Patil, SA and Cross, RK. “Can You Hear Me Now? Frequent Telephone Encounters for Management of Patients with Inflammatory Bowel Disease. (Summary of Ramos-Rivers, CM, Regueiro, M, Vargas, EJ et al. Association Between Telephone Activity and Features of Patients with Inflammatory Bowel Disease. Clin Gastroenterol Hepatol). Clin Gastroenterol Hepatol. 2014;12(6):995-996. 

  40. Ghazi, LJ, Lydecker, AD, Patil, SA, Rustgi, A, Cross, RK, and Flasar, MH. Racial Differences in Disease Activity and Quality of Life in Patients with Crohn’s Disease. Dig Dis Sci. 2014;50(10):2508-2513.

  41. Osterman, MT, Aberra, FN, Cross, R, Liakos, S, McCabe, R, Shafran, I, Wolf, D, Hardi, R, Nessel, L, Brensinger, C, Gilroy, E, and Lewis, JD. A Randomized Controlled Trial of Mesalamine Dose Escalation for Ulcerative Colitis in Remission. Clin Gastroenterol Hepatol. 2014;12(11):1887-93.

  42. Flasar, MH and Cross, RK. What is the need for comparative effectiveness studies in IBD? Expert Rev Gastroenterol Hepatol. Early online, 2014;8(8):851-4.

  43. Zullow, S, Flasar, MH, Greenberg, D, Tracy, JK, Rustgi, A, and Cross, RK. A Health Survey of Gastroenterologist Prescribing Practices of Adalimumab for Treatment of Crohn’s Disease: Final Results. Gastroenterology & Hepatology. 2014;10(8):1-7.

  44. Regueiro, MD, Greer, JB, Binion, DG, Schraut, WH, Goyal, A, Keilo, DJ, Cross, RK, Williams, ED, Herfarth, HH, Siegel, CA, Oikonomou, I, Brand, MH, Hartman, DJ, Tublin, ME, Davis, PL, Baidoo, L, Szigethy, E, and Watson, AR. The Inflammatory Bowel Disease Live Interinstitutional and Interdisciplinary Videoconference Education (IBD LIVE) Series. Inflamm Bowel Dis. 2014;20(10):1687-95.

  45. Ghazi, LJ and Cross, RK. The Role of Telemedicine and E-Health in the Management of Inflammatory Bowel Disease: Improving Patient Outcomes. Smart Homecare Technology and Telehealth. 2015;3:17-24.

  46. Cross, RK, Jambaulikar, Guruprasad, Langenberg, P, Tracy, JK, Collins, JF, Katz, J, Regueiro, M, Schwartz, DA, and Quinn, CC. TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and Implementation of Randomized Clinical Trial. Contemp Clin Trials. 2015;132:132-44.

  47. Joshi, G, Cross, RK, and Flasar, MH. Race and Inflammatory Bowel Disease. Practical Gastroenterology. 2009;33(1):23-33.

  48. Patil, SA and Cross, RK. Update in the Management of Extraintestinal Manifestations of Inflammatory Bowel Disease. Curr Gastroenterol Rep 2013;15(3):314.

  49. Stoddard, PB, Ghazi, LJ, Wong-You-Cheong, J, Cross, RK, and Vandermeer, FQ. Magnetic Resonance Enterography: State of the Art. Inflamm Bowel Dis 2015;21(1):229-39.

  50. Ghazi, LJ, Patil, SA, and Cross, RK. Sexual Dysfunction in Inflammatory Bowel Disease. Inflamm Bowel Dis. 2015; 21(4):939-47.


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For more information about our services or treatment options or to refer a patient to the IBD Program, please call 410-706-3387.

         
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