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Ustekinumab for Ulcerative Colitis(UNIFI Jr Trial)
UNIFI Jr Trial Summary
This trial will study whether ustekinumab is effective and safe for treating children with ulcerative colitis, as well as how the body processes the drug.
- Ulcerative Colitis
UNIFI Jr Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
UNIFI Jr Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
UNIFI Jr Trial Design
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Who is running the clinical trial?
- Group 1: Induction Period (I): Ustekinumab
- Group 2: Maintenance (M) Period: Ustekinumab once every 12 Week (q12w)
- Group 3: Maintenance (M) Period: Ustekinumab once every 8 Week (q8w)
- 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 is the relationship between the drug Ustekinumab and the FDA's BSA and Body Weight guidelines?
"Ustekinumab Dose Based on BSA and Body Weight is thought to be safe, as it is a Phase 3 trial. This means that not only is there some data supporting efficacy, but multiple rounds of data also support safety."
What is Ustekinumab Dose Based on BSA and Body Weight typically used to manage?
"Ustekinumab Dose Based on BSA and Body Weight is a medication that can be used to target adrenal cortex hormones. Furthermore, it can also be used to ameliorate conditions such as an insufficient response to one or more tnf antagonist therapies, psoriasis, and severe, active crohn´s disease."
Would this clinical trial be interested in enrolling patients who are octogenarians?
"The age bracket for this clinical trial are patients who are 2 years old and up, but no older than 17 years old."
Who does this clinical trial consider to be an eligible participant?
"This study is recruiting 100 people, between the ages of 2 and 17, who have colitis or ulcerative colitise colitis or ulcerative colitis. Patients must also meet the following criteria: they must be medically stable on the basis of physical examination, medical history, and vital signs; they must have had UC diagnosed prior to screening; they must have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore greater than or equal to (>=) 2 as determined by a central review of the video of the endoscopy; a participant who has had extensive col"
Are there other instances where Ustekinumab Dose was administered based on BSA and Body Weight?
"As of right now, 35 clinical trials that are investigating Ustekinumab Dose Based on BSA and Body Weight are ongoing with 18 of those trials in Phase 3. Out of the 2840 total locations for clinical trials, most of the trials for Ustekinumab Dose Based on BSA and Body Weight are running out of Gdansk, Pomorskie."
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