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 ARE REFRACTORY TO OR INTOLERANT OF TNFINHIBITORS

Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd0 个研究点目标入组 609 人开始时间: 2014年6月13日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•? 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 to treatment with at least one TNF-inhibitor within the previous 5 years.
•? Background regimen for UC may include oral 5-ASA, oral corticosteroids, budenoside MMX, 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.
•-Chronic hepatitis B or C infection, HIV, or tuberculosis (active or latent).

发起方

Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd