IBD Research
A Leader in IBD Clinical Research
The University of Maryland Inflammatory Bowel Disease (IBD) Research Program is a national leader in clinical research, most notably the application of telemedicine in IBD to improve healthcare outcomes, disparities in care, and outcomes-based research.
The IBD Research Program has extensive experience in multiple study designs, including:
- Registries
- Pilot studies
- Investigator-initiated research projects
- Industry-sponsored trials of diagnostics and therapeutics
The IBD Research Program has received funding from the Agency for Healthcare Research and Quality, Broad Medical Research Program, Litwin IBD Pioneers Initiative, the Crohn’s and Colitis Foundation, and industry.
Crohn’s and Colitis Foundation’s Clinical Research Alliance
The University of Maryland is a member of the Crohn’s and Colitis Foundation’s Clinical Research Alliance (Raymond K. Cross, Co-Chair) and was selected as a vanguard site for the Crohn’s and Colitis Foundation’s Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease (SPARC IBD).
With more than 600 enrolled participants, the University of Maryland is the largest site in this important registry.
IBD Research Faculty
IBD Clinical Trials
The following clinical trials are open for enrollment in the IBD Research Program. If you are interested in any of these studies, please call 410-706-1IBD (1423).
| Trial | Objective | Status | Sponsor |
| ASSIST Study A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence with Inflammatory Bowel DiSease Therapy |
The goal of this clinical trial is to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. | Recruiting | Crohn’s and Colitis Foundation |
| SPARC IBD Study of a Prospective Adult Research Cohort with Inflammatory Bowel Disease |
The goals of this prospective cohort study are to identify biomarkers associated with response to treatment, disease severity, and future drug targets. | Recruiting | Crohn’s and Colitis Foundation |
| CorEvitas | The goals of this prospective cohort study are to study the natural history of IBD, prevalence and incidence of comorbidities, and targeted adverse events, as well as utilization patterns and comparative effectiveness and safety of approved IBD treatments. | Recruiting | Corrona, LLC |
| ADMIRECD-II Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants with Crohn's Disease (CD) |
The purpose of this clinical trial is to assess the efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells for the treatment of complex perianal fistulas in Crohn’s disease. | Active, not recruiting | Tigenix SAU |
| GS-US-419-3896 Diversity II A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn's Disease |
The goals of this long-term extension study to induction study GS-US-419-3895 are to evaluate the safety of filgotinib in subjects with Crohn’s disease. | Active, not recruiting | Gilead Science Incorporated |
| Abbvie M14-533 A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants with Ulcerative Colitis (UC) during the maintenance period of Study M14-234 Sub study 3, or who have successfully completed Study M14-234 Sub study 3 |
The goal of this study is to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis who have not responded at the end of the induction period, who have had loss of response during the maintenance period, or who successfully completed maintenance treatment of Study M14-234. | Active, not recruiting | AbbVie Inc. |
| Induction Optimization with Stelara for Crohn's Disease | The goals of this 16-week clinical trial are to compare a second intravenous induction dose to standard 90 mg subcutaneous maintenance dose of Stelara at week 8. | Not recruiting | Janssen Scientific Affairs, LLC |
| The OPTIMIZE Trial Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with Crohn’s disease |
The goals of this clinical trial are to evaluate the effectiveness of iDose-driven infliximab dosing versus standard of care dosing in maintaining steroid-free clinical remission. | Not recruiting | Beth Israel Deaconess Medical Center |
| Gene Discoveries in Subjects with Crohn’s Disease of African Descent | The goals of this study are to collect DNA, serum, and tissue biopsies from children and adults with and without IBD for the purpose of genotype analysis. | Not recruiting | National Institute of Diabetes and Digestive and Kidney Diseases |
| A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis | The goals of this clinical trial are to compare the effectiveness of ABX464 versus placebo on clinical remission in patients with moderate to severe ulcerative colitis. | Not recruiting | Abivax |
| CHASE-EIM Cohort for Healing Arthritis, Skin, and Eye Extra-Intestinal Manifestation |
The goal of this prospective registry is to determine the clinical presentation of peripheral arthritis and investigate if use of immunotherapy or biologics induces improvement or remission. | Not recruiting | Crohn’s and Colitis Foundation |
| DUET-CD A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease |
The goals of this clinical trial are to evaluate the effectiveness of JNJ-78334804 at week 48 compared with guselkumab or golimumab in patients with moderate to severe Crohn’s disease. | Not recruiting | Janssen Research and Development, LLC |
| DUET-UC A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis |
The goals of this clinical trial are to evaluate the effectiveness of JNJ-78334804 at week 48 compared with guselkumab or golimumab in patients with moderate to severe ulcerative colitis. | Not recruiting | Janssen Research and Development, LLC |
| Compass-CD Study | The goals of this study are to assess the use of a Crohn’s disease risk prediction tool to describe risk profiles of patients with Crohn’s disease in real world practice. | Not recruiting | Takeda Pharmaceuticals Company Limited |
|
Ozanimod Study |
The goals of this clinical trial are to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants with Moderate to Severe Ulcerative Colitis in clinical practice. | Not recruiting | Bristol Myers Squib |