CLINICAL TRIAL

Ustekinumab Dose Based on BSA and Body Weight for Ulcer

Recruiting · < 18 · All Sexes · Rochester, MN

This study is evaluating whether a drug called ustekinumab may help treat ulcerative colitis.

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About the trial for Ulcer

Eligible Conditions
Colitis · Colitis, Ulcerative · Ulcer

Treatment Groups

This trial involves 3 different treatments. Ustekinumab Dose Based On BSA And Body Weight is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Ustekinumab Dose Based on BSA and Body Weight
DRUG
+
Matching Placebo
DRUG
Experimental Group 2
Ustekinumab Dose Based on BSA and Body Weight
DRUG
Experimental Group 3
Ustekinumab Dose Based on BSA and Body Weight
DRUG
+
Matching Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Matching Placebo
2012
Completed Phase 4
~10790

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 74 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 74 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ustekinumab Dose Based on BSA and Body Weight will improve 9 primary outcomes and 11 secondary outcomes in patients with Ulcer. Measurement will happen over the course of Week 8.

US Specific: Number of Participants with Clinical Remission at I-8 Visit
WEEK 8
Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Number of Participants With Clinical Response at I-8 Visit
WEEK 8
Clinical response is defined as decrease from baseline in the modified Mayo score by >= 30 percent (%) and >=2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1.
Endoscopic Improvement at I-8 Visit
WEEK 8
Endoscopic improvement is defined as a Mayo endoscopy subscore of 0 or <= 1 with no friability present on the endoscopy.
Number of Participants with Symptomatic Remission at I-8 Visit
WEEK 8
Symptomatic remission is defined as Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline.
Global: Number of Participants with Clinical Remission at Induction Week 8 (I-8) Visit
WEEK 8
Clinical remission is defined as Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Clinical Remission at I-8 as Assessed by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI) Score
WEEK 8
Clinical remission is defined as a PUCAI score less than (<)10.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for ulcer?

The general consensus among physicians is that patients with ulcer should receive surgery or medication but that many physicians do not consult specialists with this condition. Ulcer is treated in many ways.

Anonymous Patient Answer

What is ulcer?

Ulcer is an inflammation of the mucous membranes of the urogenital and gastrointestinal systems. Common ulcers are found on the lower gastrointestinal tract. Chronic and uncontrolled infections with bacteria or viruses or with parasites are all causes of ulcer pathology.\n

Anonymous Patient Answer

What causes ulcer?

A person's genetic predisposition plays an important role in the onset and development of ulcer in the stomach and esophagus. Tobacco, alcohol and NSAIDs/aspirin use may also increase the risk further. However, the cause of most ulcers remains unknown.\n

Anonymous Patient Answer

What are the signs of ulcer?

The most common symptom of stomach ulcer is chronic stomachache. This symptom is not specific for gastric ulcer, but it is often the first sign of stomach ulcer. It is not possible to rule out gastric irritation with certainty, because the symptoms of irritation can become quite similar with ulcer. Also, if ulcer is not serious, but just very painful or there are some symptoms like nausea, vomiting or dizziness, but the diagnosis is only for a few minutes, gastric irritation can be considered. When there are some other specific signs like pain in extremities, chest pain, sweating, fever or blood in stool, the diagnosis of stomach ulcer is more certain.

Anonymous Patient Answer

How many people get ulcer a year in the United States?

According to the 1997 NASE survey, about 1.5 million Americans have an ulcer at some time each year. In this population, rates of major ulcers were about the same as those in Western European countries. Factors that increase the prevalence of an uncomplicated ulcer include age and alcohol consumption. Preventing ulcer is as important as treating it.

Anonymous Patient Answer

Can ulcer be cured?

Most patients with moderate to severe ulcers could not be cured. Treatment of mild ulcers had a success rate of up to 90%. Better results appear with treatment when the ulceration is asymptomatic.

Anonymous Patient Answer

What does ustekinumab dose based on bsa and body weight usually treat?

Ustekinumab treatment is not associated with significant weight gain compared with TNF blockers. Thus, ustekinumab seems to be a promising candidate for obese subjects with active relapsing Crohn's disease. We need to evaluate a larger multicenter study to further explore the efficacy and safety of ustekinumab in obese adults with luminal inflammatory bowel diseases.

Anonymous Patient Answer

Have there been any new discoveries for treating ulcer?

Current treatments of ulcer are usually not better than placebo. Nevertheless, new treatment modalities have the potential to offer a significant and reliable breakthrough for patients with ulcer.

Anonymous Patient Answer

What are the common side effects of ustekinumab dose based on bsa and body weight?

Bsa or weight showed a difference in drug induced side effect incidence. Bsa is a better measure to predict for drug effects in a clinical setting when calculating the proper bsa, due to the ease of use and quick response.

Anonymous Patient Answer

Does ustekinumab dose based on bsa and body weight improve quality of life for those with ulcer?

The current evidence indicates that ustekinumab improves QoL in chronic Crohn's disease. Dose-based adjustment of ustekinumab for bioavailability improves treatment efficacy while preserving QoL and may be an option in treatment-resistant patients.

Anonymous Patient Answer

How serious can ulcer be?

In the modern intensive care unit, we see few patients with severe or life-threatening illnesses who are still hospitalized. Ulceration is a common problem and can often be successfully cured.

Anonymous Patient Answer

Does ulcer run in families?

Children's and their families and parents should be alerted to the significant occurrence of gastric ulcers in families, and that gastric ulcer disease can be prevented.

Anonymous Patient Answer
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