NCT00162942已完成3 期
A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Crohn's Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 73
- 主要终点
- Clinical Remission
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.
详细描述
Trial Features:
- Medical device (Non-drug option)
- Most patients can remain on current treatment regimen throughout the study
Components of the Study:
- Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments
- Physical exams, laboratory tests and disease assessments conducted at no charge to the patient
- 2:1 Randomization (treatment:sham)
- Open-Label extension offered to eligible patients
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
- •Moderate to severe Crohn's disease
- •Adequate peripheral venous access
- •Agree to participate in the required follow-up visits
- •Able to complete a diary
- •Signed written informed consent document and authorization for use of protected health information
排除标准
- •Extremely severe Crohn's disease
- •Known obstructive symptoms within the past 3 months
- •Presence of toxic megacolon
- •Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
- •Total colectomy, ileostomy, stoma or 100 cm of resected small bowel
- •Requiring in-patient hospitalization
- •A history of allergic reaction to heparin or heparin-induced thrombocytopenia
- •A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
- •A history of severe cardiovascular or peripheral arterial diseases
- •A history of cerebral vascular diseases
- •Liver diseases
- •Renal insufficiency
- •Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment
- •Any hypercoagulable disorder
- •Known infection with Hepatitis B or C, or HIV
- •Severe anemia
- •Leukopenia or granulocytopenia
- •Evidence of current systemic infection
- •Malignancy
- •Pregnant, lactating or planning to become pregnant during the course of the investigational study
- •Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic
结局指标
主要结局
Clinical Remission
时间窗: Baseline to Week 12
Clinical Remission is defined as a Crohn's Disease Activity Index (CDAI) score of ≤150 when evaluated at Week 12
Frequency and Severity of Adverse Events Through Week 12
时间窗: Baseline through Week 12 Visit
All subjects who received at least one apheresis treatment session were included in the intent-to-treat population (ITT). The ITT population was used for effectiveness analysis.
次要结局
- CDAI Score Change From Baseline(Baseline to Week 12)
- Clinical Response(Baseline to Week 12)
- Mean Change in Short-Form 36 Questionnaire (SF-36) Physical Component Summary (PCS) Score(Baseline to Week 12)
- Mean Change in Short-Form 36 Questionnaire (SF-36) Mental Component Summary (MCS) Score(Baseline to Week 12)
- Mean Change in Inflammatory Bowel Diseases Questionnaire (IBDQ)(Baseline to Week 12)
- Mean Change in EuroQol Score (Single Index)(Baseline to Week 12)
- Mean Change in EuroQol Score (Visual Analog Scale)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (Time Management)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (Physical Demands)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (Mental-Interpersonal Demands)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (Output Demands)(Baseline to Week 12)
- Mean Change in Work Limitations Questionnaire (WLQ Index)(Baseline to Week 12)
- Mean Change in Crohn's Disease Endoscopic Index of Severity(Baseline to Week 12)
- Mean Change in Subject Global Rating(Baseline to Week 12)
- Mean Change in C-Reactive Protein(Baseline to week 12)
研究者
研究点 (73)
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