临床试验/NCT00297648

NCT00297648已完成3 期

A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFα) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease.

UCB Pharma19 个研究点分布在 3 个国家目标入组 89 人开始时间: 2006年2月最近更新: 2011年8月31日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: UCB Pharma
入组人数: 89
试验地点: 19
主要终点: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
•Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

排除标准

•Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
•History of tuberculosis or positive tests for tuberculosis at screening
•All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
•Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

结局指标

主要结局

Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments

时间窗: Baseline, Week 10

The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.

Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments

时间窗: Baseline, Week 10

次要结局

Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments(Week 10)
Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments(Week 10)
Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments(Week 54)
Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments(Week 54)
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments(Baseline, Week 10)
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments(Baseline, Week 10)
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments(Baseline, Week 54)
Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments(Baseline, Week 54)
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments(Week 10)
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments(Week 10)
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments(Week 54)
Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments(Week 54)
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments(Week 10)
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments(Week 10)
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments(Week 54)
Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments(Week 54)
Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment(Baseline, Week 10)
Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment(Baseline, Week 54)
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10(Baseline, Week 10)
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54(Baseline, Week 54)
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10(Week 10)
Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54(Week 54)
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10(Week 10)
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10(Baseline, Week 10)
Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52(Week 52)
Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52(Baseline, Week 52)
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10(Week 10)
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment(Week 10)
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment(Week 10)
Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment(Week 10)
Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment(Baseline, Week 54)
Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment(Baseline, Week 54)
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10(Baseline, Week 10)
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54(Baseline, Week 54)

研究者

发起方

UCB Pharma

申办方类型

Industry

责任方

Sponsor

研究点 (19)

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