NL-OMON36733已完成2 期
A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease - AMG 827 treatment in subjects with Crohn's disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •4.1.1 Subject was randomized into study 20090072 and completed the week 12 evaluation.
- •4.1.2 Subject completed the week 12 evaluation in study 20090072 no more
- •than 1 year prior to the planned first visit of AMG 827 in 20100008.
- •4.1.5 For subjects with * 3 months between the week 12 visit of 20090072 and
- •the planned first dose of AMG 827 in 20100008: If testing is clinically
- •indicated in the opinion of the investigator (eg, because of known recent
- •exposure), then subject has negative test for hepatitis B, hepatitis C,
- •and/or human immunodeficiency virus (HIV).
- •4.1.8 For subjects with * 3 months between the week 12 visit of 20090072 and
- •the planned first dose of AMG 827 in 20100008, if clinically indicated in
- •the opinion of the investigator (eg, because of known recent exposure):
- •* If the subject entered 20090072 with a negative purified protein
- •derivative (PPD) test: Subject must have a negative PPD test within
- •30 days prior to the planned first dose of AMG 827. Tuberculin skin
- •tests should be considered positive when they have greater than or
- •equal to 5 mm of induration at 48-72 hours after test is placed.
- •* If the subject entered 20090072 with a positive PPD: Subject must
- •have a negative Quantiferon test within 30 days prior to the planned
- •first dose of AMG 827.
排除标准
- •AMG 827 specific criteria
- •4.2.1 Subject had any serious adverse event reported during study 20090072
- •and considered to be related to investigational product.
- •Other medical conditions
- •4.2.4 Subject is currently experiencing an infection of Common Terminology
- •Criteria for Adverse Events grade 2 (if requiring oral medication) or
- •higher. Subject is ineligible until the infection resolves.
- •4.2.5 Subject has a serious infection, defined as requiring hospitalization or
- •intravenous antibiotics, within 8 weeks before the first dose of AMG 827
- •in 20100008.
- •4.2.6 For subjects with * 3 months between the week 12 visit of 20090072 and
- •the planned first dose of AMG 827 in 20100008: Subject has recurrent or
- •chronic infections, defined as * 3 infections requiring anti-microbials over
- •the past 12 months prior to screening.
- •4.2.7 Subject has a significant concurrent medical condition, including
- •* Type 1 diabetes
- •* Uncontrolled type 2 diabetes
- •* Moderate to severe heart failure (New York Heart Association class III
- •* Myocardial infarction within the last year
- •* Current or history of unstable angina pectoris within the last year
- •* Uncontrolled hypertension as defined by resting blood pressure
- •* 150/90 mmHg prior to first investigational product dose (confirmed
- •by a repeat assessment)
- •* Severe chronic pulmonary disease (eg, requiring oxygen therapy)
- •* Major chronic inflammatory disease or connective tissue disease
- •other than Crohn*s disease (eg, systemic lupus erythematosus,
- •rheumatoid arthritis, psoriasis)
- •* Active malignancy, including evidence of cutaneous basal or
- •squamous cell carcinoma or melanoma
- •* History of cancer (except successfully treated in situ cervical cancer
- •or squamous or basal cell carcinoma of the skin).
- •Laboratory abnormalities
- •4.2.8 For subjects with > 4 weeks between the week 12 visit of 20090072 and
- •the planned first dose of AMG 827 in 20100008, subject has laboratory
- •abnormalities at screening, including
- •* Elevated aspartate aminotransferase or alanine aminotransferase
- •(> 2x upper limit of normal)
- •* Serum direct bilirubin * 1.5x upper limit of normal
- •* Hemoglobin < 10 g/dL
- •* Hemoglobin A1c > 8.0 (for subjects with type 2 diabetes)
- •* Platelet count < 125,000 /mm3
- •* White blood cell count < 3,000 cells/mm3
- •* Absolute neutrophil count < 2,000/mm3
- •* Creatinine clearance < 50 mL/min (Cockroft-Gault formula, central lab
- •will calculate value and provide to sites)
- •Washouts and non-permitted drugs
- •4.2.9 Subject has used Tysabri (natalizumab) subsequent to study 20090072.
- •4.2.10 Subject received an anti-tumor necrosis factor agent within 8 weeks prior
- •to the first dose of AMG 827 in 20100008.
- •4.2.11 Subject received other commercially available biologic agent (eg,
- 另有 9 项未显示
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