This trial is evaluating whether Filgotinib will improve 1 primary outcome and 2 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of Baseline and up to 432 weeks.
This trial requires 1000 total participants across 5 different treatment groups
This trial involves 5 different treatments. Filgotinib is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Signs of ileocolitis include diarrhea with blood. Pain in the lower abdomen may indicate colitis involving the ileum and appendix. Fever and tenderness over the site of the lesion may indicate appendicitis.
About 914,000 people in the US will suffer from ileocolitis at some point in their lives. There has been steadily declining incidence of UC and IBD across America, with peak incidence peaks occurring at age 50 with a prevalence of 10 to 30 cases per 100,000 population. The American College of Gastroenterology (ACG) recently adopted a formal medical diagnosis of UC. There is now a standard set of questionnaires for clinicians to use in their assessment of possible intestinal disease. These questionnaires can be used to accurately identify a diagnosis of UC. Furthermore, there is an increased reporting by patients of severe flare-ups. There is increasing evidence that people will develop inflammation even without a demonstrable diagnosis.
Data from a recent study demonstrates that patients with ileocolitis have significantly improved symptoms when treated with mesalamine. Data from a recent study of this study suggest that the treatment of IBS can be successful.
Ileopathy should be recognised by the patient and is the most common cause of bowel disorders. Patients can usually recognise symptoms, and the diagnosis is readily made in an exploratory context.
Common treatment for IC includes medications and surgery. Other medications used to target symptoms include acetaminophen, laxatives, and other substances to treat diarrhea. Surgery may include either ileostomy or ileoanal anastomosis, and various minimally invasive procedures may be used to control symptoms of IC. Patients are also offered counseling and education.
All patients with ileocolitis have some form of gastrointestinal involvement. The diagnosis of ileocolitis is most often made when the symptoms of colitis, particularly diarrhea, occur with an associated symptom suggestive of inflammatory bowel disease.
About half of those patients have the condition at age 50 or older. A recent increase in the average age at ileocolitis diagnosis suggests a declining incidence of the condition which may have important public health implications.
Filgotinib is a well-tolerated drug and has a significant role in treating patients with Crohn’s disease and ulcerative colitis. Commonly reported side effects are mostly mild or moderate but may include diarrhea, nausea, vomiting, dyspepsia, constipation, headache, dizziness, and fatigue. Physicians should be aware of these side effects when prescribing filgotinib to patients with any health condition.\n- Filgotinib Prescribing Information, from CIDRAP : http://ePAS.cidrap.ucd.edu/content/clinic/patient.
Filgotinib treatment significantly reduces the frequency or duration of pouchitis, ulcers, and fistula in patients with ulcerative colitis who undergo restorative proctocolectomy with ileal pouch-anal anastomosis. Filgotinib-based anti-TNF therapy for ulcerative colitis is highly effective and can result in the long-term remission of patients.
A significant family history of ileocolitis is found in patients with Crohn's disease. The high prevalence of these associations and their significant linkage to IBD8 in our population has not been reported before. Findings from a recent study suggest that the prevalence of familial ileocolitis in the population at large may not be negligible.
Filgotinib was well tolerated in people with UC. The most common adverse events were diarrhea, nausea, and fatigue. Filgotinib has been associated with liver injury in animals. The liver analyte data in this study were consistent with those from previous clinical studies.
There is no clinical trial registered on [www.clinicaltrials.gov]. However, the FDA and EMA have approved filgotinib for the treatment of moderate to severe inflammatory bowel disease (IBD). Multiple clinical trials are being studied for indications of IBD that is refractory to current treatments, (IBD-refractory, ulcerative colitis (UC), Crohn's disease, and ulcerative colitis-anal cancer (UC-AC)). The primary endpoint is the efficacy of filgotinib for IBD and UC-AC. Filgotinib is being evaluated for this indication.