A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
研究概览
简要总结
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab.
At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment.
Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.
详细描述
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have active UC or CD.
The study will enroll approximately 150 patients. Participants will be assigned to the vedolizumab treatment group.
•Vedolizumab 300 mg
Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2, 6 and 10 (CD-participants who have not shown a response can receive a dose at Week 10) during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.
This multicentre trial will be conducted in India. The overall time to participate in this study is 74 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit after receiving their last dose of drug for a follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of >=8 for CD at the time of enrolment.
- •Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
- •Conventional therapy
- •TNF-α alpha antagonist
排除标准
- •Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
- •Has active or latent tuberculosis (TB).
- •Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
- •Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
研究组 & 干预措施
Vedolizumab 300 mg
Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2 and 6 during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.
干预措施: Vedolizumab IV (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
时间窗: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)
AE was defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with the treatment. AE can therefore be any unfavourable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with use of a drug, whether or not it is considered related to the drug. A SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI (serious or nonserious) was one of scientific and medical concern specific to the compound or program.
Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs
时间窗: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)
An ADR was an AE for which there was at least a reasonable suspicion of a causal relationship between an AE and a suspected medicinal product. An unexpected ADR was an ADR with the nature, severity, or outcome which was not consistent with the product insert.
次要结局
- Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46(At Weeks 14, 30 and 46)
- Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46(At Weeks 14, 30 and 46)
- Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46(At Weeks 14, 30 and 46)
- Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46(At Weeks 14, 30 and 46)
- Percentage of UC and CD Participants Who Discontinued Vedolizumab(From first dose of study drug up to Week 46)
- Percentage of UC Participants With Mucosal Healing at Week 46(At Week 46)
- Percentage of CD Participants With Mucosal Healing at Week 46(At Week 46)
- Percentage of UC Participants With Endoscopic Response at Week 46(At Week 46)
- Percentage of CD Participants With Endoscopic Response at Week 46(At Week 46)
- Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46(Baseline, Weeks 14, 30 and 46)