This trial is evaluating whether Filgotinib will improve 4 primary outcomes and 10 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Week 10.
This trial requires 1374 total participants across 4 different treatment groups
This trial involves 4 different treatments. Filgotinib 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.
Overall, filgotinib was well-tolerated in our study. The common side effects of the medication included nausea, fatigue, constipation, headaches and diarrhea. Filgotinib was not associated with an increased risk of developing cancers or serious infections. These side effects were similar to those reported in previous clinical trials.
Although the diagnosis is often made based on clinical presentation, many patients with IBD have an underlying subclinical inflammation that doesn't completely resolve when in remission. Therefore, patients with IBD are not aware of their disease's real extent, which could potentially affect them as their illness progresses. Therefore, IELIS-PODIS (Ileocolitis Assessment and Management Using a Simple Patient Questionnaire) can be used to measure disease progression in IBD and can be used to evaluate new treatments for the disease and to monitor relapse risk in patients with IBD. Furthermore, if the disease severity progresses in patients with IBD, this can affect their ability to manage their pain and manage their side effects from medications.
The ileocolitis in inflammatory bowel disease and other diseases is a clinical syndrome. It is not a specific disease entity and the pathogenesis of it is not a uniform entity. For instance, colonic biopsy from patients with ileocolitis may show inflammation without the characteristic epithelial changes of inflammatory bowel diseases of the colon and pouch. In many patients, ileocolitis may be the earliest sign of inflammatory bowel disease. In this context it is important to specify the specific diagnosis of the disease, and for this reason guidelines were published in 2002 and 2010. However, these criteria and guidelines have been criticized owing to inadequate clinical research.
The optimal treatment for patients with ulcerative colitis is not completely established. However, many patients may be managed on a maintenance treatment regimen with medications including NSAID, corticosteroids, and 5-ASA's. This allows the use of a more effective therapy by titrating at a manageable low dose and prevents disease flares at the same time. The management of patients with Crohn's disease is still controversial and is currently investigated. Patients with more severe disease may receive surgery and/or bioprosthetic therapy for more serious disease flares.
Ileocolitis in Crohn's disease and ulcerative colitis is primarily a disease of the mucosa, and can only be cured by the removal of the mucosal lesions as a whole.
Symptoms which may be features of [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) include weight loss, bloody stools, tiredness, diarrhea, loss of appetite and abdominal pain. Symptoms which can also be present when ileocolitis is part of ulcerative colitis such as weight loss, bloody stools, tiredness, diarrhea, diarrhea-predominant right-sided colitis and the presence of erythema nodosum may all be signs of ulcerative colitis rather than ileocolitis. While some patients may have a mixed diagnosis of ileocolitis and ulcerative colitis, either presentation can be enough to diagnose a colonic Crohn's disease.
In a recent study, findings demonstrates that ileocolitis is an autoimmune condition associated with elevated levels of TNF-alpha and IL-6, whereas TGF-beta is probably of normal low level. Measurement of IL-6 and TNF-alpha in intestinal tissue may be useful in differentiating the cause of inflammatory colitis.
iliacocolitis, although uncommon, affects patients of all ages. Approximately 3 out of 10 of these patients were women over the age of 60, and half were black. iliacocolitis had a similar incidence for colon, ileo, and ceco-pelvic colitis within the same patient. It was an important differential diagnosis from colonic Crohn's disease and colitis, the two other most common types of ileitis. Further investigation is required to establish the prevalence and mechanisms of iliacocolitis.
In this pooled analysis filgotinib was found to significantly reduce the relapse rates for both pouch surgery and adhesion surgery for all patients treated. A subset of patients with a high-risk profile in terms of IPAA-related co-morbidities demonstrated significantly improved outcomes upon treatment with filgotinib. This pooled analysis showed that filgotinib did not seem to negatively influence the intestinal healing as reported for other small bowel cancer indications.
Ileocolitis affects 2.8-8 (6–14%) of people in hospitals. Complications can occur, such as abscess formation, perforation, leakage of fluid from the ulceration, sepsis, septic arthritis, bowel obstruction and/or the release of toxic substances from the ulceration, and abscess formation. The prognosis is dependent on what stage of ulceration is discovered. Most cases are asymptomatic, but in the advanced stage of surgery, most patients are hospitalized, and prognosis deteriorates. Prognosis of the disease is poor.
(a) There is potential for the use of the medication to treat Crohn's disease and its use in this way merits further investigation. (b) The drug is a first-in-class kinase inhibitor for the treatment of gastrointestinal tumors. The drug is also being investigated in the treatment of other gastrointestinal diseases, such as pancreatitis, ulcerative colitis, and colorectal cancer. (c) The drug seems effective but has a number of undesirable side effects, including hypertension, fatigue, and nausea.
The therapies for ileocolitis are more developed than those for colitis due to its long duration. New research will continue to clarify what treatments can manage the symptoms effectively long term. The treatment for ileocolitis is still challenging and patients will require continued follow-up to assess their symptoms and the best treatment for their condition.