This trial is evaluating whether Mirikizumab will improve 1 primary outcome and 12 secondary outcomes in patients with Colitis. Measurement will happen over the course of Baseline through Week 52.
This trial requires 30 total participants across 3 different treatment groups
This trial involves 3 different treatments. Mirikizumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"Ulcers are a major cause of morbidity and functional impairment in the elderly. There is no single cause (e.g. NSAID consumption) but a number of contributing factors (e.g. smoking, alcohol consumption) and this should also be considered when setting the goal to avoid ulcers in high-risk patients using topical and/or systemic treatment, or if prophylaxis is being contemplated." - Anonymous Online Contributor
"Nonsteroidal anti-inflammatory drugs (NSAIDs), when used in excess or in combination with other potentially damaging drugs, increase the risk of peptic ulcers, which in turn, are an increased risk factor of upper gastrointestinal bleeding (UGIB). NSAID can cause UGIB through a number of pathways. Firstly, by disrupting the protective mucosal barrier through the action of prostaglandins, NSAIDS cause mucosal bleeding from the underlying mucosa by altering mucosal blood flow, mucinaemia, edema and hyperemia (hyperaemic ulcer). This causes a defect that can be seen between the superficial mucosa, the submucosa and muscle layer of the mucosa (duodenal ulcers)." - Anonymous Online Contributor
"Most Americans have one or more uncomplicated, acute [ulcers] a year, and in the United States, the majority of patients with acute [ulcers] can be treated with a brief course of oral medications, or with a short course of bedrest. Ulcers are common in all age groups, and approximately 24.6 million new cases (2.6 percent of all cases) occurred in 2013. In 2013, the estimated incidence rate of uncomplicated and uncomplicated-complicated ulcers was 4.2 and 6.3 cases per 100,000 persons, respectively. Most cases of uncomplicated acute [ulcers] occurred in persons ages 50 to 69 years." - Anonymous Online Contributor
"Most cases of painful oesophageal or duodenal ulcer can be cured, though not in all. For oesophageal ulcer, the presence of Barrett's oesophagus and Helicobacter pylori infection should be treated before ulceration develops. For duodenal ulcer, initial ulceration usually heals without surgery, and relapse usually occurs due to reflux disease. When surgery is required, most patients may be cured." - Anonymous Online Contributor
"Ulcer management guidelines have been validated for the use in the US. Ulcers are common in the outpatient clinic and are a common cause of outpatient department visit, but most referrals were made for treatment in the inpatient setting. Patients with chronic ulcers also have significant medical and social consequences, and are more likely to be treated with aggressive and costly medications." - Anonymous Online Contributor
"Uncomplained stomach pain is a reliable sign of ulcus. The presence of red patches or hemorrhages on abdominal examination is another strong sign of ulcus. Abdominal radiograph is the gold standard, and can be used to confirm the diagnosis. The presence of H. pylori infection should be considered to prevent recurrence of peptic ulcer when found to be negative on endoscopy." - Anonymous Online Contributor
"Symptoms of acute lower GI complaints are significantly increased as people get older. This should not be mistaken for true ulcer, which appears to be rare." - Anonymous Online Contributor
"Clinical trials may be an alternative or adjunct to medical therapy in GI-related medical disorders to support and aid therapy, to evaluate therapeutic outcome, or to compare therapeutic regimens." - Anonymous Online Contributor
"Mirikizumab was associated with significantly greater improvements in VAS scores, SF-36 QOL, and a significantly decreased relapse rate in MDE compared to a placebo. The difference in remission rate in MDE was more clinically relevant than the increase in SF-36 QOL in the placebo group. (Multicenter, double-blind, randomized, placebo-controlled trials NCT00991247 and NCT01432451). (http://www.clinicaltrials.gov)." - Anonymous Online Contributor
"Mirikizumab is generally well tolerated (as with other anti-IL-23 medicines in the recent past). The most common side effects were infection and infusion reactions. Mirikizumab shares some common side effects such as fatigue, infections, infusion reactions, and rash with tocilizumab." - Anonymous Online Contributor
"Mirikizumab treatment resulted in improvements in pain, and HRQoL. Mirikizumab significantly improved QoL as opposed to placebo. Mirikizumab represents an important new treatment option for patients at risk for recurrence following ulcer-associated lower gastrointestinal bleeding." - Anonymous Online Contributor
"We believe that ulcerations on the GI tract can be divided into three types: local, inflammatory, and inflammatory and neoplastic. Ulcerative colitis constitutes the most common GI mucosal inflammatory bowel disorder. Inflammatory and neoplastic pathogenesis are less common. Ulcerative colitis is the most clinically significant form of inflammation of the GI tract, and is generally considered a benign condition, with ulcers of the colon accounting for roughly 10% of cases. Ulcers in this context are usually encountered in patients with chronic colitis." - Anonymous Online Contributor