A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

F. Hoffmann-La Roche Ltd0 个研究点目标入组 1,250 人开始时间: 2015年1月27日最近更新: 2022年3月21日

试验速览

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•- 18-80 years of age (inclusive)
•- Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
•- Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years
•- Use of 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 1200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•- A history of, or current conditions affecting the digestive tract, such as ulcerative colitis, indeterminant colitis, abdominal or perianal abscess,
•adenomatous colonic polyps, colonic mucosal dysplasia, and short bowel syndrome
•- Sinus tract with evidence for infection (e.g., Fistula with purulent discharge) in the clinical judgment of the investigator. Fistulas related to Crohn's disease are not exclusionary
•- Planned surgery for CD
•- Ileostomy or colostomy
•- Has 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, active or latent tuberculosis (patients with prior history of BCG vaccination must pass protocol-defined screening criteria)

发起方