A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Date Added
July 18th, 2025
PRO Number
Pro00144159
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

This study will evaluate the efficacy and safety of RO7790121 compared with placebo in patients with moderately to severely active CD. Data on currently available treatments highlights the need for new medications in addressing the high unmet need in CD. The total maximum duration of study participation for an individual is expected to be approximately 70 weeks without OLE participation. With OLE participation, treatment will continue until RO7790121 is commercially available in that region or until the Sponsor decides to terminate the study, whichever is earlier. Approximately 600 patients will be enrolled in the study.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

MIrikizumab in UC a Real-woRld prOspective multicenteR registry

Date Added
March 18th, 2025
PRO Number
Pro00142550
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

The goal is to see how well mirikizumab works for people with ulcerative colitis. This involves looking at its effects in their everyday lives. Understanding its real-world benefits helps determine how effective the medicine is outside of controlled clinical trials.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

Confidence Optimization through Resources for Education, Engagement, and Empowerment (CORE) Study

Date Added
June 29th, 2023
PRO Number
Pro00128946
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

This research study is being conducted to gather information about patients with inflammatory bowel disease (IBD) to better understand their knowledge and preferences about self-help resources and learn how to help patients better manage their disease. Participation in this study will involve signing a research consent form, completing questionnaires, and the opportunity to participate in self-help resources. Some participants may be offered the opportunity to participate in a virtual focus group, as well. Participation in the study will last approximately 3 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

IBD Qorus: Improving the Quality of Care for Adults with Inflammatory Bowel Disease

Date Added
February 22nd, 2023
PRO Number
Pro00125585
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

The goal of this study is to collect health information from adults with IBD to better understand the disease and ultimately improve care for participants and other adults living with IBD. Participation in this study is voluntary. If a subject agrees to be in this study, we will collect information electronically (through a web-based platform called IBD Qorus) from the subject and the subject's IBD health care provider about their IBD health information.

Approximately 50 sites across the U.S. are currently participated in this study. The study is sponsored by the non-profit Crohn's and Colitis Foundation.

With the collected medical data, the study will focus on the strategy of identifying goals (or targets) of IBD care, developing a strategy to reach these goals, and then continuously evaluating progress of achieving these targets and modifying the treatment plan.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

CorEvitas Inflammatory Bowel Disease (IBD) Drug Safety and Effectiveness Registry

Date Added
June 8th, 2022
PRO Number
Pro00120887
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System, Non-interventional
Summary

This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-1221
recruitment@musc.edu

CorEvitas Inflammatory Bowel Disease (IBD) Drug Safety and Effectiveness Registry

Date Added
June 8th, 2022
PRO Number
Pro00120887
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System, Non-interventional
Summary

This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Zerlinna Teague
(843) 792-1221
recruitment@musc.edu



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