PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY

F. Hoffmann-La Roche Ltd0 个研究点目标入组 800 人开始时间: 2014年6月10日最近更新: 2020年7月13日

试验速览

暂无简介。

•Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
•18-80 years of age, inclusive.
•Moderately to severely active ulcerative colitis (UC) as determined by the Mayo Clinic Score assessment (MCS).
•Intolerance, loss of response, or failure to respond or neither inadequate response or intolerance to treatment with at least one TNFinhibitor within the previous 5 years.
•Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside therapy, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period.
•Use of highly effective contraception as defined by the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 776
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps.
•Prior or planned surgery for UC.
•Past or present ileostomy or colostomy.
•Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol.
•Any prior treatment with anti-adhesion molecules (e.g., anti-MAdCAM-1)
•Chronic hepatitis B or C infection, HIV, or tuberculosis (active or latent).

发起方