临床试验/NCT01336465

NCT01336465已完成2 期

Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Genentech, Inc.0 个研究点目标入组 124 人开始时间: 2011年9月最近更新: 2016年8月12日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Genentech, Inc.
入组人数: 124
主要终点: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of moderate to severe ulcerative colitis outpatient
•Disease duration at time of screening of >/= 12 weeks

排除标准

•Extensive colonic resection or subtotal or total colectomy
•Presence of an ileostomy or colostomy
•Moderate to severe anemia
•A history or evidence of colonic mucosal dysplasia
•Pregnant or lactating
•Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
•Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
•Poorly controlled diabetes
•Impaired renal function
•Impaired hepatic function in the absence of a diagnosis of primary sclerosing cholangitis
•Positive tests for antibodies indicating active or prior infection with HIV or hepatitis B (HBV) or C (HCV)
•Positive screening test for latent mycobacterium tuberculosis (TB) infection
•Demyelinating disease
•Received any investigational treatment within 12 weeks prior to initiation of study treatment
•Previous exposure to rhuMAb Beta7

研究组 & 干预措施

rhuMAb Beta7

Experimental

干预措施: rhuMAb Beta7 (Drug)

placebo

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point

时间窗: Week 10

次要结局

Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1(Week 6 and Week 10)
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point(Week 6)
Proportion of patients with endoscopic score and rectal bleeding score of 0(Week 6 and Week 10)

研究者

发起方

Genentech, Inc.

申办方类型

Industry

责任方

Sponsor

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