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 Early withdrawn subjects during the first treatment phase cannot enter the extension phase.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,...
A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.
The proposed study is a randomized, double-blind,placebo-controlled, multi-center phase II study to investigatethe safety and efficacy of SHR0302 in patients with moderate to severe activeulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 andtime needed in inducing clinical response in active ulcerative colitispatients. This is an 8+8 weeksstudy, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded activearms 8-week extension phase. Early withdrawn subjects during the first treatment phasecannot enter the extension phase. The total duration of the study...
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.
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....
A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy
Phase IV Design : Prospective, open-label, randomized three-arms study Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration Main co-primary end points Clinical relapse rate at 2 years Mean...
Aquamin® as an Adjuvant Intervention for Ulcerative Colitis In Remission
The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will extend remission in patients with stable Ulcerative Colitis.
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 arm: ...
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 network...
A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of V565 in participants with active Crohn's Disease.
Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease
The investigators hypothesize that a novel method for oligosaccharide supplementation, in the form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS), will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD) in remission.