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A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3
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A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease
The proposed study is a randomized, double-blind, placebo-controlled, multi-center Phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active Crohn's Disease. The study aims to evaluate the optimal dose of SHR0302 and time needed in inducing clinical remission in active CD. This is an 12+12 weeks study, in which participants who complete the first 12 weeks treatment phase, will have the option to enter a blinded active arms 12-week extension phase. Early withdrawn subjects during the first treatment phase cannot enter the extension phase. The total duration of the study participation,...
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A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
This is a Phase 3, randomized, double-blind, placebo-controlled study to demonstrate the effect of oral ozanimod as maintenance therapy in subjects with moderately to severely active Crohn's Disease.
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A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Response to Biological Therapy in Patients With CD
Crohn's disease (CD) is a chronic relapsing-remitting systemic inflammatory disease, affecting any part of the gastrointestinal tract. Biological therapy with anti-tumor necrosis factor (TNF) alpha is the established treatment of choice for the management of moderate to severe Crohn's disease. However, its efficacy in an individual patient is the unpredictable and long-term outcome is still suboptimal. Identifying biomarkers which can predict treatment response is thus of utmost importance and can allow personalized management. In inflammatory bowel disease (IBD), altered fecal microbiota signatures have been consistently reported....
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Aquamin® as an Adjuvant Intervention for Ulcerative Colitis
The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission.
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A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis
PHASE : IV TYPE OF STUDY : With direct benefit. DESCRIPTIVE : Multicentre, randomized, open label study. INCLUSION CRITERIA : Acute severe ulcerative colitis. OBJECTIVES : To compare the efficacy and safety of early administration of the combination therapy with infliximab and azathioprine with steroids and azathioprine in patients with acute severe ulcerative colitis treated with intravenous steroids. STUDY TREATMENTS : All patients : Intravenous steroids (0.8 mg/kg/day of methylprednisolone or equivalent) for 5 days. Combination therapy arm: Infliximab 5 mg/kg plus Azathioprine 2-2.5 mg/kg/day. Azathioprine...
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AR-Power Patient Powered Research Network
ArthritisPower is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), and other musculoskeletal conditions. Participants will provide information from their smartphones or personal computers. The information will be used by researchers to help patients and their providers make better, more informed decisions about treatment of RA/SpA and other musculoskeletal conditions. ArthritisPower is part of a larger national research ...
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Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea
The prevalence of ulcerative colitis (UC), which is one of the inflammatory bowel diseases, is known to be increasing and the majority of patients (≥ 85%) have experienced mild or moderate severity. 5-Aminosalicylic acid (5-ASA), immunomodulator, or biologics, etc are prescribed to treat UC, however 5-ASA is generally considered the first-line therapy. The recent UC treatment guideline in Korea and the United States/ European Union (US/EU) have recommended higher daily dose for patients with mild or moderate severity than the previous guidelines since 2017. Accordingly, it is assumed that the average daily treatment dose of 5-ASA...
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Assessment of Nutritional Status of Patients With Crohn's Disease
Good nutritional status of patients with Crohn's disease (CD) is associated with better outcome of the disease. The prevalence of malnutrition in patients with Crohn's disease varies and is higher in patients with active disease. Available studies in the literature have assessed the nutritional status of patients with Crohn's disease. However, sample size of available studies is small and highly heterogeneous, and most patients are hospitalized with active disease. The aim of the present study is a thorough assessment of nutritional status of 220 patients either with active Crohn's disease or in remission of the disease using...
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Association Between Self-reported Web-based SCCAI and Health-related Quality of Life Index in UC Patients
An accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (UC). Recent studies have reported that the Simple Clinical Colitis Activity Index (SCCAI) correlates well with Mayo score. A recent report demonstrated that SCCAI has a significant correlation with the degree of health-related quality of life in UC patients. It is also reported that the self-administered SCCAI through the web-based input tool at home is highly correlated with the SCCAI assessed by physician. The aim of this study was to investigate the relationship between self-administered web-based SCCAI and the ...
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