Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with Crohn's disease: The OPTIMIZE Trial

Date Added
April 18th, 2023
PRO Number
Pro00123816
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

This clinical trial is studying a new approach to how we calculate the dose of infliximab for patients with Chrohn's Disease. Participants are randomized to either the iDose Dashboard, which is a computer program that helps determine the infliximab dosage, or to currently accepted standard of care. All participants will receive IV doses similar at the beginning of the study, but will then be randomized to receive either the treatment arm in which they will use the iDose dashboard or the Standard of care arm in which they will receive dosing every 8 weeks, which is in accordance for the usual care of the patient.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
shannonz@musc.edu

An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis

Date Added
February 28th, 2023
PRO Number
Pro00127209
Researcher
Erin Forster

List of Studies


Keywords
Ulcerative colitis
Summary

This is an open label, multi-center study to evaluate the long-term safety and tolerability of BMS-986165 in participants with moderate to severe CD or moderate to severe UC who have completed one of the applicable parent studies (IM011023, IM011024, and IM011127), are likely to safely derive a clinical benefit from ongoing treatment with BMS-986165, and are willing and able to participate. Participants will receive BMS-986165 6 mg BID by mouth (PO) in a tablet formulation. Approximately 300 participants are expected to rollover from the parent studies into Study IM011077. All participants must have completed 1 of the parent studies (Studies IM011023, IM011024, or Study IM011127) and must meet all eligibility criteria. The duration of the study is approximately 296 weeks (2,072 days). There will be a Qualification and enrollment period (up to 28 days), Open label study period (288 weeks), and a Post-treatment follow-up period (4 weeks).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
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

A PHASE 3, MULTICENTER, OPEN-LABEL EXTENSION STUDY OF ORAL OZANIMOD FOR MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Date Added
March 23rd, 2021
PRO Number
Pro00104265
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this study is to see whether oral Ozanimod is safe and effective for treating Crohn's disease. Adult participants (at least 18 years old) with moderately to severely active Crohn's disease may be eligible.

Only participants who complete the induction and/or maintenance study will be eligible to join this open-label study.

All participants in this study receive active study drug. The dose of study drug you will receive will depend on your prior study. There is no chance of placebo in this study.

This study is designed to last up to 234 weeks (4.5 years). Participants are expected to come to MUSC every 8 or 12 weeks for study visits.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS MAINTENANCE THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Date Added
March 23rd, 2021
PRO Number
Pro00104264
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this study is to see whether Ozanimod is safe and effective for treating Crohn's disease. Adult participants (at least 18 years old) with moderately to severely active Crohn's disease may be eligible.

To do this, a comparison will be made between subjects who receive active drug and subjects who receive placebo (a ‘dummy treatment' that looks like the active drug but contains no active ingredient). The chance of being randomized (like drawing names out of a hat) into ozanimod group and receiving ozanimod is 50%. The chance of being randomized into placebo group and receiving placebo is 50%.

If participants' Crohn's disease condition get worse during the study, they will be invited to participate the open-label study, which has no placebo.

This is a one-year study, and participants are expected to come to MUSC every 8 weeks for study visits.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

INDUCTION STUDY #1 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE

Date Added
January 26th, 2021
PRO Number
Pro00102262
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this study is to see whether Ozanimod is safe and effective for treating Crohn's disease. Participants who are aged 18 to 75 years with moderately to severely active Crohn's disease may be eligible.

To do this, a comparison will be made between subjects who receive active drug and subjects who receive placebo (a ‘dummy treatment' that looks like the active drug but contains no active ingredient). The chance of being randomized (like drawing names out of a hat) into ozanimod group and receiving ozanimod is 67%. The chance of being randomized into placebo group and receiving placebo is 33%.

This study is designed to last up to 30 weeks, including 2 screening visits, 4 study visits, and 2 follow-up visits. The study drug may improve participant's Crohn's disease condition, but this cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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