A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 41
- 主要终点
- Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
研究概览
简要总结
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
详细描述
After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.
Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80
- •Diagnosis of moderately to severely active Crohn's disease
- •Crohn's Disease involvement of the ileum and/or colon
- •Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
- •May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
- •Exclusion Criteria
- •Evidence of abdominal abscess at the initial screening visit
- •Extensive colonic resection, subtotal or total colectomy
- •History of >3 small bowel resections or diagnosis of short bowel syndrome
- •Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
- •Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
- •Active or latent tuberculosis
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
干预措施: Placebo (Other)
Vedolizumab
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
干预措施: vedolizumab (Drug)
结局指标
主要结局
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
时间窗: Week 6
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
次要结局
- Percentage of Participants With Sustained Clinical Remission in the Overall Population(Week 6 and Week 10)
- Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation(Baseline and Week 6)
- Percentage of Participants in Clinical Remission at Week 6 in the Overall Population(Week 6)
- Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation(Week 10)
- Percentage of Participants in Clinical Remission at Week 10 in the Overall Population(Week 10)
- Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population(Week 6 and Week 10)
- Number of Participants With Adverse Events (AEs)(From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.)