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Optimal Treatment Strategies for Ulcerative Colitis (VERDICT Trial)
VERDICT Trial Summary
This trial will help determine the optimal treatment target for UC.
VERDICT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVERDICT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VERDICT Trial Design
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Who is running the clinical trial?
Media Library
- I have short gut syndrome.I have been treated with vedolizumab, etrolizumab, or natalizumab.I have never had brain-related health issues like PML.I do not have active or latent TB, or I have a negative TB test in the last year.My ulcerative colitis is active, with bleeding and inflammation seen in a colonoscopy.I have no medical reasons preventing me from taking vedolizumab.I have HIV or tested positive for it in Italy.I am current with my colorectal cancer screenings as per guidelines.I haven't changed my oral steroid dose in the last 2 weeks and take no more than 30 mg of prednisone or its equivalent.I am a man who can father children and will use birth control during and for 18 weeks after the study.I am 18 years old or older.I haven't had any live vaccines in the last 4 weeks, except for COVID-19.My ulcerative colitis diagnosis was confirmed by tests and doctor's evaluation.I am a male and do not plan to donate sperm during the study or for 18 weeks after.My current treatment for ulcerative colitis is not working.I have used topical treatments like corticosteroids or 5-ASA in the last 2 weeks.I agree to use birth control during and for 18 weeks after the study.I do not have a severe infection like sepsis or CMV.I have been diagnosed with a specific type of colitis.I am not pregnant, breastfeeding, planning to become pregnant, or donate eggs within 18 weeks after the last dose.I have tried at least 2 different treatments for my UC without success.I can fully participate in all parts of this clinical trial.
- Group 1: Symptomatic and endoscopic remission
- Group 2: Symptomatic, endoscopic and histological remission
- Group 3: Symptomatic remission
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Is this research a pioneering endeavor?
"This therapeutic intervention has been under investigative scrutiny since 2015. With the commencement of a Takeda-funded trial involving 260 participants, it was approved for its fourth phase in drug trials and is now being studied across 42 countries with 23 active investigations occurring in 312 cities."
In what number of health institutions is this experiment being conducted?
"This medical trial is being carried out at Weill Cornell Medicine in New york, TIDHI in Toronto, Michigan and London Health Sciences Centre - University Campus located in London Alberta. Additionally, there are 13 other sites that are also participating."
What other empirical investigations have explored this therapeutic approach?
"AZ Sint Lucas was the first to investigate this therapy back in 2015. Since then, a total of 38 clinical trials have been completed, with 23 others still active - many being conducted out of New york City."
What potential hazards may arise from this treatment?
"Our staff at Power believes that the safety rating of this treatment is a 3, as it has been authorized by Phase 4 trials which provide evidence for both efficacy and security."
Are there any remaining enrollment opportunities for this research project?
"Affirmative, the information available on clinicaltrials.gov stipulates that this trial is currently recruiting participants. This research project was first advertised on September 17th 2020 and has been recently revised as of April 4th 2022; its objective being to select 660 patients from 13 different medical centres."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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