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Etrolizumab for Ulcerative Colitis (COTTONWOOD Trial)
COTTONWOOD Trial Summary
This trial will study the efficacy and safety of etrolizumab as a treatment for moderate to severe ulcerative colitis. The trial will last for up to 9 years and will enroll participants who have completed the 12-week safety follow-up period from the Phase II OLE study or the Phase III studies.
- Ulcerative Colitis
COTTONWOOD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COTTONWOOD Trial Design
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Who is running the clinical trial?
Media Library
- I'm sorry, can you please provide more context or information regarding "Part 2 (Safety Monitoring)"?This is not an exclusion criterion, but rather an indication that this is the first part of the study.You have a new and serious health condition that is not being properly managed.
- Group 1: Part 1: Open-label Extension
- Group 2: Part 2: Safety Monitoring
- 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
How many people are participating in this study at most?
"This trial is no longer active. The study was first made public on September 15th, 2014 and the last update was on September 29th, 2022. For those still searching for trials to participate in, there are presently 424 clinical trials actively looking for patients with colitis, ulcerative and 3 studies for Etrolizumab actively searching for patients."
Has the United States Food and Drug Administration cleared Etrolizumab for patient use?
"There is some evidence supporting the efficacy of etrolizumab, as this is a phase 3 trial. Furthermore, there have been multiple rounds of data that support its safety; thus, it receives a score of 3."
Is this study taking place in several hospitals across North America?
"73 patients have already been recruited for this clinical trial, which is being conducted at Great Lakes Gastroenterology Research, LLC in Mentor, SDG Clinical Research in San Diego, University of California, Irvine Medical Center in Orange, and other locations."
Do we have room for more participants in this trial?
"No, this particular trial is not enrolling patients at the moment according to the information available on clinicaltrials.gov. Although the last update was on September 29th, 2022, this study was first posted almost 8 years ago on September 15th, 2014. There are however 427 other trials that are still looking for participants."
Does this research stand alone or has there been previous investigation into Etrolizumab?
"Currently, there are three different clinical trials underway that are studying etrolizumab. Out of those three, two are in phase 3. Most of the research regarding etrolizumab is taking place in Kozyataği, New jersey; however, 1045 other sites across the globe are also running similar investigations."
Is this an original study?
"Eight clinical trials have been completed for Etrolizumab since its initial Phase 3 drug approval in 2014. Presently, there are three ongoing studies being conducted across 253 cities and 44 countries."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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