NCT04963725已完成不适用
Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported Outcomes
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 23
- 主要终点
- Percentage of Participants With a Rectal Bleeding Score of 0 or 1
研究概览
简要总结
The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a confirmed diagnosis of ulcerative colitis (UC) in accordance with local practice
- •Has a current UC severity that is judged by the treating physician to be moderate to severe (being a partial Mayo score of 5 to 9, inclusive)
- •A decision has been made by the treating physician and the participant within routine clinical practice to commence treatment with ustekinumab, having been deemed to have an inadequate response to, or intolerant to, previous UC therapy
- •Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements. If the participant is 16 to 19, informed consent might be obtained from each study participant according to the regulation of institution/hospital and their legally acceptable representative must sign an ICF
- •Must be able to read, understand, and complete participant-reported outcome instruments, and intend to cooperate with completion of participant-reported outcome instruments using smartphone/tablet
排除标准
- •Has ever previously received ustekinumab (including clinical trial use)
- •Are currently receiving, or have received within the past 3 months, systemic treatment with a biologic therapy for any other indication (example Crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
- •Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point
- •Currently enrolled in an interventional study or another Janssen-sponsored observational study (including post-marketing surveillance)
- •Based on physician judgement has i) severe extensive colitis and is at imminent risk of colectomy OR ii) a stoma or history of a fistula OR iii) previously had extensive colonic resection (example, less than 30 centimeter (cm) of colon remaining) OR iv) current fulminant colitis OR v) currently hospitalized for worsening of UC-related symptoms (not excluded if the reason for hospitalization is first dose of ustekinumab)
研究组 & 干预措施
Participants Initiating Therapy with Ustekinumab
Data will be collected for participants in Japan who have had an inadequate response, or been intolerant to, conventional or biologic therapies. The treating physician has made the decision to initiate ustekinumab induction therapy in the routine clinical practice - either as a first or subsequent biologic therapy initiating for their moderate to severe ulcerative colitis.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Percentage of Participants With a Rectal Bleeding Score of 0 or 1
时间窗: Up to Week 8
The rectal bleeding scores of 0 and 1 using physician's global assessment will be reported where 0 indicates 'No blood seen' and 1 indicates 'Streaks of blood with stool less than half the time'.
Percentage of Participants With a Stool Frequency Score of 0 or 1
时间窗: Up to Week 8
The stool bleeding scores of 0 and 1 using physician's global assessment will be reported where 0 will indicate 'Normal number of stools' and 1 will indicate '1 to 2 stools more than normal'.
次要结局
- Change From Baseline in Rectal Bleeding Score Through Week 8(Baseline, Up to Week 8)
- Change from Baseline in Calculated Partial Mayo Score at Week 8 and Week 16 or Week 20(Baseline, Week 8 and Week 16 or Week 20)
- Change from Baseline in Abdominal Pain Through Week 8(Baseline, Up to Week 8)
- Percentage of Participants with Perceived Improvement in Ulcerative Colitis (UC)(Up to Week 8)
- Change from Baseline in Stool Frequency Score Through Week 8(Baseline, Up to Week 8)
- Percentage of Participants with a Reduction in Rectal Bleeding Score of Greater than or Equal to (>=) 1 From Baseline(Up to Week 8)
- Percentage of Participants with Reduction in Stool Frequency Score of >= 1 From Baseline(Up to Week 8)
- Change from Baseline in Rectal Bleeding Score at Week 16 or Week 20(Baseline, Week 16 or Week 20)
- Change from Baseline in Stool Frequency Score at Week 16 or Week 20(Baseline, Week 16 or Week 20)
- Percentage of Participants with Presence of Nocturnal Diarrhea(Up to Week 8)
- Percentage of Participants with Presence of Tenesmus(Up to Week 8)
研究者
研究点 (23)
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