NCT00004941已完成3 期
Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
FDA Office of Orphan Products Development0 个研究点目标入组 94 人开始时间: 1996年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
研究概览
简要总结
OBJECTIVES:
I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in closure of enterocutaneous fistulae in patients with Crohn's disease.
详细描述
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to investigational site and number of fistulae (single vs multiple).
Patients are randomized to one of three treatment arms: Arm I: Patients receive an infusion of chimeric monoclonal antibody (cA2) on weeks 0, 2, and 6. Arm II: Patients receive an infusion of cA2 on weeks 0 and 2, and an infusion of placebo on week 6. Arm III: Patients receive an infusion of placebo on day 1 of weeks 0, 2, and 6.
Patients are followed every month for 3 months, then every 6-12 months for up to 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Crohn's disease of at least 3 months duration confirmed by radiography or endoscopy
- •Single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration
- •All fistulae separate and distinctly identifiable
- •No local complications of Crohn's disease such as strictures or abscesses
- •-Prior/Concurrent Therapy--
- •Biologic therapy:
- •No prior chimeric monoclonal antibody (cA2)
- •At least 3 months since treatment with other therapeutic agent targeted at reducing tumor necrosis factor (e.g., pentoxifylline or thalidomide)
- •At least 4 weeks since cyclosporine
- •Chemotherapy:
- •Concurrent methotrexate permitted if treatment began at least 3 months prior to enrollment, dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period
- •Otherwise, no methotrexate within 4 weeks prior to enrollment
- •Concurrent 6-mercaptopurine or azathioprine permitted if treatment began at least 6 months prior to enrollment, dose has been stable for at least 8 weeks prior to enrollment, and remains stable throughout study period Otherwise, no 6-mercaptopurine or azathioprine within 4 weeks prior to enrollment
- •Endocrine therapy:
- •Concurrent corticosteroids (e.g., oral prednisone) permitted if dose has been stable for at least 3 weeks prior to enrollment, does not exceed 40 mg/kg, and remains stable throughout study period (dosage may be tapered after 6 weeks for some patients)
- •Otherwise, no corticosteroids within 4 weeks prior to enrollment
- •Concurrent antibiotics or aminosalicylates for Crohn's disease permitted if dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period
- •Otherwise, no antibiotics or aminosalicylates within 4 weeks prior to enrollment
- •At least 3 months since investigational drugs
- •-Patient Characteristics--
- •Hematopoietic:
- •WBC at least 3,500/mm3
- •Neutrophil count at least 1,500/mm3
- •Lymphocyte count at least 500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 8.5 g/dL
- •No severe, progressive, or uncontrolled hematologic disease
- •SGOT no greater than 3 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 3 times ULN
- •No severe, progressive, or uncontrolled hepatic disease
- •Creatinine no greater than 1.7 mg/dL
- •No severe, progressive, or uncontrolled renal disease
- •Cardiovascular: No severe, progressive, or uncontrolled cardiac disease
- •Pulmonary: No severe, progressive, or uncontrolled pulmonary disease
- •Neurologic: No severe, progressive, or uncontrolled neurologic or cerebral disease
- •Negative pregnancy test required and no planned pregnancy within 7.5 months following first infusion
- •Effective contraception required of fertile patients during and for 6 months after study
- •No severe, progressive, or uncontrolled endocrine disease
- •No serious infections (e.g., hepatitis, pneumonia, pyelonephritis) within prior 3 months
- •No history of opportunistic infections (e.g., herpes zoster) within 2 months
- •No allergy to murine proteins
- •No active cytomegalovirus, Pneumocystis carinii, or drug resistant atypical mycobacterial infections
- •No recent drug or alcohol abuse
- •No HIV infection, ARC (AIDS-related complex) or AIDS
- •Total parenteral nutrition or tube feeding not permitted
- •No prior or concurrent malignancy within 5 years
排除标准
- 未提供
研究者
相似试验
已完成
3 期
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney CancerKidney CancerNCT00087022Heidelberg Pharma AG864
Unknown
2 期
Cetuximab, Leucovorin, Oxaliplatin, and Fluorouracil With or Without Bevacizumab in Treating Patients With Resectable Liver Metastases From Colorectal CancerMetastatic CancerColorectal CancerNCT00438737European Organisation for Research and Treatment of Cancer - EORTC100
已完成
2 期
Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion ReactionsInfusion ReactionMonoclonal AntibodyNCT04198623University of California, San Francisco40
已完成
2 期
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney CancerStage IV Renal Cell CancerRecurrent Renal Cell CancerNCT00019539National Cancer Institute (NCI)
已完成
2 期
Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and NeckHead and Neck CancerNCT00084318Radiation Therapy Oncology Group238