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Oral Ozanimod for Crohn's Disease
Study Summary
This trial is testing a new drug to see if it can help Crohn's Disease patients who are in moderate to severe pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 1320 Patients • NCT02047734Trial Design
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- My Crohn's disease is active but not extremely severe.I have been diagnosed with a type of colitis or have strictures needing treatment.I have a stoma, ileal-anal pouch, or fistula.I have had a major part of my small intestine removed or I need nutrition through an IV.I have been diagnosed with Crohn's disease for at least 3 months.I experience frequent bowel movements or significant abdominal pain daily.My condition didn't improve with steroids, immune treatments, or biologics.
- Group 1: Administration of Placebo
- Group 2: Administration of oral Ozanimod
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
For what medical condition is Ozanimod most commonly prescribed?
"Ozanimod is an effective intervention for treating sclerosis, multiple sclerosis, and carcinoma in situ."
Do numerous hospitals in the United States have this trial underway?
"Select patients are being accepted at 64 different hospitals and research institutes across America, such as Northwestern University in Chicago, Illinois, Sun Research Institute in San Antonio, Texas, and Medical University Of South carolina in Charleston, South Carolina."
What makes this test unique compared to others like it?
"Ozanimod has undergone extensive research since first being studied in 2015. A Phase 3 drug approval was received following the initial 2350 person trial sponsored by Celgene. As of now, there are 11 active studies taking place across 52 countries and 287 cities."
Are there any patients who have not yet been enrolled in this research project?
"That is correct, the online clinicaltrials.gov database indicates that this research project is currently looking for volunteers. The trial was first announced on February 27th 2018 with the latest update being November 8th 2022. So far, 64 different hospitals or clinics have agreed to participate and help recruit the 600 patients needed."
How many study participants are there in total?
"In order to move forward, this clinical trial requires 600 patients that fit the bill in terms of age, health, and other inclusion criteria. Participating patients will visit one of many sites - two examples being Northwestern University located in Chicago, Illinois or Sun Research Institute based in San Antonio, Texas."
Could I qualify to take part in this research?
"This study is seeking 600 individuals that suffer from ileocolitis and meet the following conditions: being between 18-75 years old, a Crohn's disease Activity Index (CDAI) score of ≥ 220 and ≤ 450, a Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease),Crohn's disease present on endoscopy and histological exam for 3 months or more, an average daily stool frequency ≥ 4 points and/or abdominal pain of ≥ 2 points, inadequately responsive or"
What is the historical data on Ozanimod's clinical efficacy?
"Ozanimod was first studied in 2015 at Local Institution - 554. There have been 18302 completed studies since then, with 11 more ongoing trials. Of these active studies, a few are based in Chicago, Illinois."
Does this research include middle-aged or elderly participants?
"According to the study's eligibility requirements, patients must be aged 18-75. There are currently 70 trials underway for patients that are underaged and 206 for senior citizens."
What are some of the potential dangers associated with Ozanimod?
"Ozanimod's safety is based on Phase 3 clinical trial data, and it has received a score of 3 from our analysts."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
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