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Closed for Enrollment
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Mongersen GED-0301 Maintenance Therapy in Subjects With Crohn's Disease
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.
A Phase III, Randomized, Placebo-Controlled, Double-Blind, Multicenter, Induction Study to Investigate the Efficacy and Safety of GED-0301 for the Treatment of Subjects with Active Crohn's Disease
The purpose of this study is to test the effectiveness and safety of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease.
Collection of Blood in Patients with Inflammatory Bowel Disease
The purpose of this study is to create a group of blood and urine samples and quality of life data from Mayo Clinic patients with a diagnosis of inflammatory bowel disease (IBD). The blood and urine samples and quality of life data will be used for future research of IBD at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.
Multicenter, Prospective, Randomized Study Comparing PillCam ® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease (BLINK)
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease. The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease. There will be assessment of mucosal disease activity at baseline and 6- and 12- month follow ups. Patient satisfaction questionnaires will be completed at baseline, 6- and 12- month follow ups along with a Quality of Life questionnaire at 12 month follow up. Concomitant medication and adverse events information will be collected baseline and 3-, 6-, 9- and 12 month follow ups.
Use of Medication Therapy Management to Optimize Care Through Effective Resource Management in Inflammatory Bowel Disease
Eau Claire, Wis.,
La Crosse, Wis.
The management of Inflammatory Bowel Disease (IBD) is complex and time consuming. While Current Procedural Terminology for MTM services are available they are under-utilized given the time constraints placed on practitioners trying to address multiple health care issues during a single visit. There are companies that specialize in patient pharmacy services to improve health care outcomes. Our aim is to utilize these services in a small number of IBD patients to assess effectiveness of such services within a tertiary care practice.