CLINICAL TRIAL

Ustekinumab for Ileocolitis

Waitlist Available · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a higher dose of a medication may help individuals with Crohn's disease.

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About the trial for Ileocolitis

Treatment Groups

This trial involves 2 different treatments. Ustekinumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ustekinumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Ustekinumab
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
FDA approved

Side Effect Profile for Ustekinumab (Stelara)

Ustekinumab (Stelara)
Show all side effects
Upper respiratory infection
50%
Common cold
27%
Skin and subcutaneous tissue disorders
9%
Back pain
9%
Urinary tract infection
9%
Dizziness
9%
Anxiety
9%
Fracture
9%
Hypertension
5%
Pain/Pain in extremity
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Toothache
5%
Blistering
0%
Endometritis
0%
Vasovagal reaction
0%
Alkaline Phosphatase Increased
0%
Hepatic Lesion
0%
Ear And Labyrinth Disorders/Ear Pain
0%
Anhedonia
0%
Gastritis
0%
Stroke
0%
Allergies to foods, food additives, drugs and other chemicals
0%
Latent Tuberculosis
0%
Hypotension
0%
Pain
0%
Panic Attack
0%
External ear pain
0%
Nasal congestion
0%
Dermatitis Irritant Contact
0%
Uterine hemorrhage
0%
Pyelonephritis
0%
Stomach pain
0%
Dysplastic Nevus
0%
Productive cough
0%
Uterine Fibroids Enlarged
0%
Trichomoniasis
0%
Viral Infection
0%
Would Healing Delayed
0%
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT02187172) in the Ustekinumab (Stelara) ARM group. Side effects include: Upper respiratory infection with 50%, Common cold with 27%, Skin and subcutaneous tissue disorders with 9%, Back pain with 9%, Urinary tract infection with 9%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People between the ages of 18 and 70, either male or female. show original
For patients receiving ustekinumab, all concomitant medications, including corticosteroids, should be continued at stable doses for at least 3 months prior to the first dose of ustekinumab show original
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Week 16
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Week 16.
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 will improve 1 primary outcome and 5 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Week 0, Week 16.

Change in Crohn's Disease Activity Index (CDAI) Score
WEEK 0, WEEK 16
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. A CDAI score of less than 150 is considered to be clinical remission, a score greater than 220 is considered to define moderate to severe disease, and a score greater than 300 is considered to be severe disease.
Number of patients with clinical remission
WEEK 16
The Crohn's Disease Activity Index or CDAI is frequently used to assess disease severity. It gives a score ranging from 0 to over 600, based on a diary of symptoms kept by the patient for 7 days, and other measurements such as the patient's weight and haematocrit. A CDAI score of less than 150 is considered to be clinical remission.
Number of patients with a composite clinical and biomarker response
WEEK 16
Defined as a drop in CDAI by at least 100 points from week 0 to week 16, or a CDAI < 150, and a biomarker response (drop in CRP and fecal calprotectin) from week 0 to week 16.
Number of patients with improvement in health-related quality of life
WEEK 16
Defined as increase in SIBDQ by at least 9 points between week 0 and week 16. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a 10-item health-related quality of life (HRQoL) questionnaire validated for use in CD patients. It assesses 4 domains: physical, social, emotional, and systemic and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). The absolute score ranges from 10 (poor HRQOL) to 70 (optimum HRQOL).
Number of patients with a clinical response
WEEK 16
A clinical response is defined as a drop in CDAI score by at least 100 points between week 0 and week 16, or a CDAI < 150.
Number of patients with a composite clinical and biomarker remission
WEEK 16
Defined as a CDAI < 150 and a CRP <5mg/l or a fecal calprotectin <150 ug/g

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 causes ileocolitis?

Ileal pouch failure was a significant cause of pouchitis. There was a significant correlation between pouch failure and pouchitis. The role of pouchitis in pouch failure is unclear.

Anonymous Patient Answer

Can ileocolitis be cured?

Although there is no definite treatment for ileocolitis, some conditions can be tackled that, along with careful surveillance and proper nutrition, may help some patients live longer and healthier lives.

Anonymous Patient Answer

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

Approximately 1 in 5 people in the United States are affected by ileocolitis. The disease has a large degree of heterogeneity in the population, with some segments of the population having higher rates than others.

Anonymous Patient Answer

What are the signs of ileocolitis?

The signs of ileocolitis vary with the location and extent of the inflammation. Often there is visible mucosal erythema. Symptoms include diarrhea with blood or pus or bowel movements not solid but grossly contaminated with blood. Periarticular tenderness and fever are common findings. In patients with severe ileocolitis, appendicitis is always present, and the diagnosis of inflammatory bowel disease should be considered.

Anonymous Patient Answer

What are common treatments for ileocolitis?

When diagnosed by endoscopy, ileitis is classified as a chronic inflammatory condition associated with a high rate of complications. In the absence of therapeutic intervention, ileitis may lead to colorectal cancer, pouchitis, and ulcerative colitis. The treatment of ileitis involves the use of several medications including immunosuppressants, NSAIDS, antibiotic therapy, NSAIDs with steroids and anti-TNF agents. The choice of treatment depends on the clinical pattern of disease and the results of the patient's condition, as well as the availability and cost of the various medications.

Anonymous Patient Answer

What is ileocolitis?

A spectrum of disease affecting ileocolonic (small and large intestinal) function may be present in functional GI disease. Clinically significant disease, as indicated by erythema or ileitis, typically appears with colonic involvement.

Anonymous Patient Answer

What is ustekinumab?

Treatment with ustekinumab is well tolerated in patients undergoing treatment for ulcerative colitis, in the majority of cases with a high rate of mucosal healing.

Anonymous Patient Answer

Has ustekinumab proven to be more effective than a placebo?

Results from a recent clinical trial showed that ustekinumab showed a better effect than placebo on the primary and secondary endpoints compared with placebo at week 16 of treatment. Overall, ustekinumab was well tolerated and not associated with unacceptable adverse events. Results from a recent clinical trial of this trial have shown that ustekinumab is clinically safe and effective in patients with an inadequately controlled Crohn's disease.

Anonymous Patient Answer

What is the average age someone gets ileocolitis?

The majority of pediatric patients with ileocolitis were under the age of 10 years. This group should be approached differently due to their relative lack of physiologic integrity during ileal inflammation. Most physicians treat this patient population with ileostomy reversal due to their lack of a functioning ileorectal valve.

Anonymous Patient Answer

What is the primary cause of ileocolitis?

The incidence of secondary ileitis is 3 times that of primary disease, with a female preponderance (1.3:1). The incidence of disease in North America is increasing, a conclusion supported by the increase in mean age, with the highest incidence at 43 years of age, in North America. However, the prevalence of disease in developing countries is lower and is concentrated in patients below 40 years of age. Most patients in the USA are diagnosed with [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) when they are older than 50 years, while younger patients are likely to be diagnosed with sclerosing colitis.

Anonymous Patient Answer

Is ustekinumab typically used in combination with any other treatments?

The authors conclude that ustekinumab and other biologic treatments do not typically have additive effects. However, a case series report has suggested that ustekinumab may have additive effects with immunosuppressive regimens. In patients already treated with a standard of care treatment who do not respond to that standard of care treatment, adding ustekinumab may increase the probability of response and a reduction in the number of medications used beyond what the standard of care treatment yields.

Anonymous Patient Answer

How does ustekinumab work?

We showed that ustekinumab treatment is safe and effective in patients with moderate to severe UC, even in patients with moderate disease activity. The majority of patients achieved PASI70.

Anonymous Patient Answer
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