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SEQUENCE Trial Summary
This trial will assess how well risankizumab works compared to ustekinumab for the treatment of Crohn's disease.
- Crohn's Disease
SEQUENCE Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSEQUENCE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 252 Patients • NCT04102007Awards & Highlights
SEQUENCE Trial Design
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Who is running the clinical trial?
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- You have certain complications related to a condition called CD (such as narrow passages or short bowels).You have received any approved or experimental biologic treatment before the start of the study.
- Group 1: Ustekinumab
- Group 2: Risankizumab Dose A Followed by Dose B
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What patients does Risankizumab show the most improvement in?
"Risankizumab is often used as an intervention for patients that may require systemic therapy. It can also treat conditions such as infection, invasive procedure, and dental plaque."
Does this research involve any elderly individuals?
"Eligibility for this trial is restricted to patients that are between 18 and 80 years old."
Is this study available in many hospitals within the city limits?
"This trial is being conducted by Digestive Disease Specialists in Oklahoma City, OK; Mayo Clinic - Rochester in Minnesotan Oklahoma City, OK; Mayo Clinic - Rochester in Minnesota; Covenant Health in Edmonton, AB; and 55 other locations."
What primary goals has this clinical trial outlined?
"The primary objective of this study, which will be evaluated over the course of 24 weeks, is to assess the percentage of patients who achieve endoscopic remission. Secondary objectives include measuring the percentage of participants who are able to achieve steroid-free remission (defined as discontinuation of corticosteroid use for 90 days while also achieving clinical remission at 48 weeks for those taking steroids at baseline), the percentage of participants who are able to achieve both endoscopic and steroid-free remission (defined as meeting criteria for both endoscopic remission and not receiving steroids at Week 48), and the percentage of participants who experience an endoscopic response at Week 24 (defined"
How many test subjects are included in this clinical research?
"This specific clinical trial is no longer looking for new patients, however there are 258 other trials related to ileocolitis and 61 studies involving Risankizumab that are currently enrolling participants."
Might I be a candidate for participating in this research study?
"This clinical trial is testing a potential new medication for ileocolitis. The study requires that patients are between 18-80 years old and around 527 people will be accepted in total."
Is Risankizumab known to have any serious side effects?
"Safety is always our top priority. Risankizumab has undergone Phase 3 trials, which means that there is data to support its efficacy and safety. We've given it a score of 3."
Are patients being recruited for this clinical trial at this time?
"The clinical trial in question, which was created on September 30th 2020 and edited most recently on August 24th 2022, is not presently looking for participants. That being said, there are 319 other medical trials that are currently recruiting patients."
What other research has been conducted with Risankizumab?
"Risankizumab was first investigated in 2011 by the researchers at Memorial Sloan Kettering Cancer Center. Since then, 175 clinical trials have been completed while 61 are ongoing. The majority of these live trials are being conducted out of Oklahomag Cancer Center. Since then, 175 clinical trials have been completed while 61 are ongoing. The majority of these live trials are being conducted out of Oklahoma City, Oklahoma."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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