Ustekinumab for Ileocolitis
This study is evaluating whether a higher dose of a medication may help individuals with Crohn's disease.
See full descriptionAbout 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.
About The Treatment
Side Effect Profile for Ustekinumab (Stelara)
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.