NCT00702611终止4 期
An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone Plus Adacolumn® GMA Apheresis vs Prednisone Alone in the Treatment of Patients With Mild or Moderately Active Steroid Dependent Ulcerative Colitis
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa48 个研究点 分布在 5 个国家目标入组 133 人开始时间: 2008年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 133
- 试验地点
- 48
- 主要终点
- Proportion of patients in steroid free clinical remission defined by Mayo Score less or equal to 2 with no individual subscore >1 at week 24
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to steroid conventional treatment for achieving and maintaining remission in Active steroid dependant Ulcerative Colitis patients
详细描述
This is a multicenter randomized controlled trial which will compare the efficacy and safety of Adacolumn GMA apheresis plus oral steroids vs steroids alone in a strictly selected population of moderate to severe active steroid dependant Ulcerative Colitis 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
- None
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
- •18 - 75 years old
- •Active ulcerative colitis with documented clinical symptoms and endoscopic findings
- •Active disease defined as DAI (Mayo score) ≥ 4 and ≤10 with at least 1 point in flexible sigmoidoscopy
- •Steroid dependency as defined by:
- •A. Inability to withdraw corticosteroids within three months of starting treatment, without recurrent active disease
- •B. appearance of relapse within 3 months after withdrawal of corticosteroids
- •Colonic involvement with ulcerative colitis beyond 15cm of the anal verge
- •Stable doses:A. Aminosalicylates for the last 4 weeks B. Prednisolone or equivalent dose ≤ 20 mg/day for the last 2 weeks C. Azathioprine or 6-mercaptopurine at stable dose for the last 12 weeks
- •Signed informed consent form
- •Agree to participate in the required follow-up visits
- •Able to complete the diary
排除标准
- •Febrile (> 38ºC)
- •Evidence of toxic megacolon
- •Anticipated need for surgery within 24 weeks
- •Known obstructive diseases of the gastrointestinal system
- •Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
- •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
- •Requires a central venous access catheter for the apheresis treatments
- •Known infection with enteric pathogens, pathogenic ova or parasites, C. difficile toxin or CMV
- •Hypotension (systolic blood pressure <80 mmHg and/or diastolic blood pressure <50 mmHg) at screening visit only
- •Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >120 mmHg) despite medical therapy
- •A history of myocardial infarction or unstable angina within the past 6 months
- •A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
- •Prosthetic heart valve, pacemaker or other permanent implant
- •Severe cardiovascular or peripheral vascular disease, severe renal disease
- •Liver disease defined as levels of SGOT [AST], SGPT [ALT] or alkaline phosphatase >2.5x the upper limit of the normal range for the laboratory performing test
- •History of cirrhosis
- •Known bleeding disorder (PT or PTT>1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
- •Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
- •Known infection with Hepatitis B or C, or HIV
- •Abnormal hematology parameters defined as severe anemia with hemoglobin <8.5g/dL, white blood cell count of <3,500/μl and a granulocyte count < 2,000/μl
- •Fibrinogen level >700mg/dL
- •Major surgery within the past 6 months
- •Infection:Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infectionFebrile viral infection within 4 weeks of entry into the clinical investigationLess than 12 weeks from conclusion of therapy for systemic fungal infections
- •Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
- •History of dysplasia or carcinoma of the colon or lack of a complete colonoscopy in the last 12 months in patients with longstanding UC (> 10 años)
- •Current drug or alcohol abuse
- •Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
- •Used within the last 30 days an investigational drug, biologic or device or 5 half-lifes, if known, for any investigational drug or biologic
- •Received cyclosporine or tacrolimus within the last 8 weeks
- •Received infliximab within the last 8 weeks
- •Fulminant ulcerative colitis
研究组 & 干预措施
1
Experimental
Seven apheresis treatments over seven consecutive weeks (1/week) in conjunction with a starting dose of 40mg of oral prednisone per day at Week 00 for two weeks which will be tapered down to zero 5 mg/week within nine weeks
干预措施: Granulocyte Monocyte Apheresis (GMA-Apheresis) (Device)
2
Active Comparator
Treatment with starting dose of 40mg of oral prednisone per day at Week 00 for two weeks and tapered down to zero 5 mg/week within nine weeks
干预措施: Granulocyte Monocyte Apheresis (GMA-Apheresis) (Device)
结局指标
主要结局
Proportion of patients in steroid free clinical remission defined by Mayo Score less or equal to 2 with no individual subscore >1 at week 24
时间窗: week 24
次要结局
- · Clinical response according to the activity indexes Truelove & Witts, Powell Tuc, Rachmiliewitz (Clinical Activity Index), Lichtiger (Modified Truelove & Witts Severity Index), Walmsley (Simple Clinical Colitis Index(24 weeks)
- Steroid free remission (assessed by Mayo score)(Week 12)
- Response at week 12 and 24 (defined by a decrease in Mayo Score > or = to 3 points(week 12 and week 24)
- Rescue therapy requirements (new courses of steroids, cyclosporine, infliximab, or surgery) during study period(24 weeks)
- Time to relapse(24 weeks)
- Clinical remission and response at weeks 12 and 24 analysed according to concomitant use of immunosupressants(24 weeks)
- Adverse events(24 weeks)
- Acute Phase reactants change at all lab analysis(24 weeks)
研究者
研究点 (48)
Loading locations...
相似试验
进行中（未招募）
2 期
Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host DiseaseChronic Graft-versus-host-diseaseNCT04189432SCM Lifescience Co., LTD.84
已完成
1 期
Efficacy and Safety of Glucocorticosteroid Treatment in the Patients With Chronic Recurrent DILIDrug-induced Liver Injury,ChronicNCT02651350Beijing 302 Hospital80
已完成
2 期
Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain CancerMetastatic Brain CancerNCT00525590Eisai Inc.69
已完成
3 期
KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAPCommunity-acquired PneumoniaNCT03474991Julia Bielicki510
Unknown
4 期
Local Steroid Treatment for Idiopathic Granulomatous Mastitis (LSTIGM)Granulomatous MastitisNCT03766997Peking Union Medical College Hospital100