NCT00206700终止2 期
Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease
Genzyme, a Sanofi Company0 个研究点目标入组 378 人开始时间: 2003年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 378
- 主要终点
- To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease.
研究概览
简要总结
The purpose of this study is to establish a safety profile sargramostim administered in 8 week cycles to adult patients with active Crohn's disease.
详细描述
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Able to provide informed consent
- •Participated in a previous study of sargramostim in Crohn's disease within the past 12 months
- •Subjects who participated in protocols excluding concomitant steroid use:
- •Must have moderately to severely active Crohn's disease at time of screening (CDAI score >/= 220 points and less than or equal to 475 points)
- •Must be receiving less than or equal to 40 mg prednisone (or equivalent) daily at time of screening if treated with corticosteroids between completing their previous sargramostim study and entry into this study and be able to taper to less than or equal to 7.5 mg daily within one treatment cycle
- •Subjects who participated in Protocol 307501
- •Must have active Crohn's disease (CDAI score > 150 points and less than or equal to 450 points) if completely withdrawn from CS use
- •Must be receiving less than or equal to 40 mg prednisone (or equivalent) daily at time of screening, be able to taper to less than or equal to 7.5 mg daily within 2 treatment cycles, and have a CDAI score less than or equal to 450 points if not completely withdrawn from CS use
- •Have a negative serum pregnancy test within 2 weeks prior to receiving initial dose of sargramostim in female subjects of child-bearing potential (optional - may be waived by the investigator if the subject has had no interruption in contraception method since participation in the previous study)
- •Agree to use of an adequate method of contraception throughout the study period for sexually-active males and females of childbearing potential
- •Able to self-inject sargramostim or have a designee who can do so
- •Able to comply with protocol requirements
- •Have a negative stool exam if subject received a course of antibiotics since participation in the previous study
排除标准
- •Pregnant or breastfeeding female
- •Need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
- •Gastrointestinal surgery within the prior 6 months
- •Symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected
- •Serum creatinine greater than or equal to 2.0 mg/dL
- •Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin greater or equal to 2X the upper limit of normal; hemoglobin (Hb) < 8.0 gm/dL; platelet count greater than or equal to 800,000/mL; ANC less than or equal to 1,000/µL or > 20,000/µL (the exclusion of subjects with ANC > 20,000/µL applies only to entry into the first treatment cycle)
- •Use of licensed/registered anti-tumor necrosis factor (TNF) therapy such as infliximab within 8 weeks prior to first dose of study drug in this trial
- •Use of any of the following medications within 4 weeks prior to receiving the first dose of study drug: 6-mercaptopurine, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, or thalidomide
- •Use of any experimental agent in a clinical trial since participating in a sargramostim trial
- •History of allergy to yeast products or sargramostim
- •Psychiatric illness or substance abuse that would interfere with ability to comply with protocol requirements or give informed consent
- •Clinically important primary disease unrelated to Crohn's disease
- •Prior exposure to natalizumab (Tysabri)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sargramostim (Leukine) (Drug)
结局指标
主要结局
To establish a safety profile for long-term, repeated cycles of sargramostim administered to subjects with Crohn's disease.
时间窗: Not applicable for this outcome
次要结局
- Crohn's disease activity(After successive 8-week cycles of treatment)
- Duration of clinical remission and time to disease flare(After successive cycles of sargramostim therapy)
- Patient compliance(After successive cycles of sargramostim therapy)
研究者
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