This clinical trial is focused on studying the effects of a medication called Ozanimod on individuals with Crohn’s Disease, which is a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study aims to understand the long-term safety and effectiveness of Ozanimod for people who have moderate to severe forms of this disease. Ozanimod is taken orally in the form of a hard capsule.
Participants in the study will receive Ozanimod and will be monitored over a period to observe how their symptoms change. The study will look at various aspects, such as the reduction in abdominal pain and stool frequency, and improvements in the condition of the digestive tract. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Ozanimod.
The study is designed to gather information over several years, providing insights into how Ozanimod can help manage Crohn’s Disease in the long term. Participants will be regularly assessed to track their progress and any changes in their condition. This research is important for developing better treatments for those living with Crohn’s Disease.
1joining the study
Upon joining the study, the patient will be informed about the trial’s purpose, which is to evaluate the long-term safety and effectiveness of ozanimod for treating moderately to severely active Crohn’s disease.
The patient will be required to provide written consent to participate in the study.
2medication administration
The patient will receive ozanimod in the form of a hard capsule, taken orally.
The dosage and frequency of administration will be determined by the study protocol and communicated to the patient by the study team.
3monitoring and assessments
Throughout the study, the patient will undergo regular assessments to monitor the effectiveness and safety of the treatment.
These assessments may include measuring the Crohn’s Disease Activity Index (CDAI) score, which evaluates the severity of symptoms, and the Simple Endoscopic Score for Crohn’s Disease (SES-CD), which assesses the condition of the intestinal lining.
4follow-up visits
The patient will attend scheduled follow-up visits to track progress and any changes in symptoms.
During these visits, the study team will collect data on the patient’s response to the treatment and any side effects experienced.
5completion of the study
Upon completion of the study, the patient will have a final assessment to evaluate the overall impact of the treatment.
The study is estimated to conclude by March 24, 2031, at which point the patient will be informed of the study’s findings and any further recommendations.
Who Can Join the Study?
Patients must have moderately to severely active Crohn’s Disease. This means their condition is not mild and requires more intensive treatment.
Patients who did not respond or did not achieve remission after 12 weeks in specific previous studies, or those who experienced a relapse or completed certain studies, are eligible.
Patients must not have any restrictions according to local laws and must provide written consent before any study procedures begin.
Patients must be able to follow the study schedule and requirements.
Female patients of childbearing potential must agree to use a highly effective method of birth control during the study and until the 90-day follow-up visit. This includes methods like hormonal contraception, intrauterine devices, or complete abstinence.
Female patients must not have had a hysterectomy (removal of the uterus) or bilateral oophorectomy (removal of both ovaries), or must not have been postmenopausal for at least 24 months.
Both male and female patients are eligible to participate in the study.
The study includes patients from certain age groups, specifically those categorized as age range 3 and 4.
Ozanimod is a medication being studied for its potential to treat moderately to severely active Crohn’s Disease. It is taken orally and is part of a long-term study to assess its safety and effectiveness in managing the symptoms of this condition.
Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active symptoms and remission. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can vary in severity, with some people experiencing mild symptoms and others having more severe manifestations. Over time, the inflammation can cause damage to the digestive tract, affecting its ability to function properly.
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