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.
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.
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.
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.
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.
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.
This clinical trial is studying a new approach to how we calculate the dose of infliximab for patients with IBD. 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.
This study is being done to learn more about a study drug called efavaleukin alfa in people with moderately to severely active ulcerative colitis. The purpose of the study is to evaluate if efavaleukin alfa is effective and safe in improving this condition. The study drug, efavaleukin alfa, will be compared to placebo. Efavaleukin alfa is being developed by Amgen Inc., a for-profit biopharmaceutical company. Efavaleukin alfa is still experimental and is not approved by any regulatory health agency (like the Food and Drug Administration [FDA] or European Medicines Agency [EMA]).
This is a randomized, double-blind, active- and placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of induction and maintenance JNJ-78934804 therapy in participants 18 to 65 years of age (inclusive, at the time of consent), with moderately to severely active UC as determined by a modified Mayo score ≥5 and a final reported endoscopy subscore ≥2 obtained during the central review of the screening video endoscopy. Participants must also have demonstrated an inadequate initial response, loss of response, or intolerance to ≥1 approved ADT (advanced therapy inadequate responder [ADT-IR]). Overall, the study will evaluate 48 weeks of therapy with JNJ-7893480. The primary objective of the study is to evaluate the efficacy of JNJ-78934804 at Week 48
compared with each monotherapy (guselkumab alone and golimumab alone).
This is a randomized, double-blind, active- and placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of induction and maintenance JNJ-78934804 therapy in participants with moderately to severely active CD who have had an inadequate initial response, loss of response, or intolerance to ≥1 approved ADT (advanced therapy inadequate responder [ADT-IR]). This
dose-ranging study includes participants 18 to 65 years of age (inclusive, at the time of consent) with moderately or severely active CD (defined by a CDAI score ≥220 and ≤450) and either a mean daily abdominal pain (AP) score ≥2 (based on the unweighted CDAI component of AP) or a mean daily stool frequency (SF) count ≥4 (based on the unweighted CDAI component of the number of liquid or very soft stools), of at least 3 months duration, with colitis, ileitis, or ileocolitis previously confirmed in the past by radiology, histology and/or endoscopy. Participants must also have endoscopic evidence of active ileal
and/or colonic CD on the screening video ileocolonoscopy. Overall, the study will evaluate 48 weeks of therapy with JNJ-78934804