This trial is evaluating whether Upadacitinib (ABT-494) will improve 1 primary outcome in patients with Ulcer. Measurement will happen over the course of Up to 288 Weeks.
This trial requires 950 total participants across 5 different treatment groups
This trial involves 5 different treatments. Upadacitinib (ABT-494) is the primary treatment being studied. Participants will be divided into 5 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
"Most colitis-related symptoms are suggestive of the underlying condition, and only half of these signs may cause confusion with diarrhea. A stool test may be useful, but it may not accurately characterize inflammation and has poor specificity." - Anonymous Online Contributor
"Colitis may be cured with corticosteroids for short-term use, although relapse may be frequent. Better understanding of the pathophysiology of colitis and implementation of well-controlled, well-designed clinical trials with long follow-up are needed to help establish more definitive guidelines for treatment." - Anonymous Online Contributor
"Medications and alternative therapies are utilized by 1 out of 8 Americans with colitis.\n\n- American Cancer Society: Colorectal Cancer\n- Colorectal Cancer Prevention and Intervention Program website - Comprehensive and descriptive information regarding [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) pathology, medical management, and treatment options in the U.S."" - Anonymous Online Contributor
"colitis can be considered as inflammation of the large and/or left-sided colon in patients with symptoms. The diagnosis should be suspected in the setting of abdominal complaints and be confirmed by endoscopic procedures such as colonoscopy. The severity of colitis can be classified in three different grades by clinical findings, histology and by imaging methods, namely computed tomography (CT) and magnetic resonance imaging (MRI) scans. The most appropriate treatment of this disorder depends on the degree of severity of inflammation. It should be tailored to the individual situation of the patient." - Anonymous Online Contributor
"There are several causes which may increase risk for colitis. These include genetic factors and environmental risk factors such as infectious pathogens. There is more than one trigger for colitis, and multiple causative factors may exist. The exact mechanism is different in different forms of colitis. It is a challenge to understand precisely what changes in gut cells can cause colitis, and to use that information to design new treatments." - Anonymous Online Contributor
"From 1998 to 2002, there were 1,926 patients with [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) and 1,483 with Crohn's colitis in the VA Cooperative System. The rate for both is 0.36 per 100,000. The disease was diagnosed in an average of 2.4 years, with the interval of 9 months between symptom onset to symptom presentation and diagnosis on average. The average duration was 3.1 years for patients with ulcerative colitis and 4.7 years for those with Crohn's disease. The mean rate per year was 2.7 and 1.7 in patients with ulcerative colitis and Crohn's colitis, respectively." - Anonymous Online Contributor
"It was found that upadacitinib was more effective than a placebo in terms of remission, as well as maintaining remission and prolonging the duration of remission. The most common side effects were infections, hemorrhage and anemia. Data from a recent study was registered at the Japanese Clinical Trials Registry as JCR number J-11-0209." - Anonymous Online Contributor
"This phase 2 study demonstrated that weekly-taken upadacitinib (abt-494) treatment is well-tolerated in patients with moderate-to-severe Crohn's disease. Common adverse events (AEs) occurred most frequently involving the gastrointestinal (GI) tract in all patients treated with upadacitinib, with fatigue and diarrhea being the most common, and most frequently in patients who received 25 mg twice-daily upadacitinib (abt-504 or ABT-0505)." - Anonymous Online Contributor
"UPDAs have a novel mechanism of action: they inhibit the action of certain members of the Src family of kinases. The inhibitors currently used to treat many cancers have been known and used for over 50 years. This is the first time an inhibitor of Src family members is being used to treat a serious disease in its devastating effects. With the Src family members being members of the receptor tyrosine kinase (RTKs) with an important role in cancer, drug development has focused on their development. However, the Src family of kinases are known to have other functions in the process of cell communication and motility." - Anonymous Online Contributor
"There is no evidence of overall improvement from age 20 to age 60 but improvements were found in age >60 years with better quality of life and more frequent surgeries. The findings suggest that patients with colitis become increasingly symptomatic when they reach a certain age." - Anonymous Online Contributor
"Upadacitinib (abt-494) is the first selective JAK2 inhibitor discovered. It is a novel anti-inflammatory JAK2 inhibitor. It shows promise in small Phase II clinical trials for treatment of ulcerative colitis. Upadacitinib (abt-494) is FDA approved treatment for polycythemia vera (PV) in May 2011 under IND. It also showed some promising activity in Phase III clinical trials for PV and chronic myelofibrosis (MF). Upadacitinib (abt-394) is currently undergoing extensive Phase II drug development." - Anonymous Online Contributor
"The severity of abdominal pain, fever and anorexia is suggestive of a serious complication of colitis viz., abdominal abscess or bowel rupture. Colonoscopy can be helpful in identifying the exact site of inflammation. Other indications of severe and potentially life-threatening cases of colitis include vomiting blood, hemoptysis and hematuria." - Anonymous Online Contributor