ISRCTN54813778已完成不适用
A double-blind placebo-controlled pilot study of safety and tolerability of AIMSPRO® in established diffuse cutaneous systemic sclerosis
Daval International Ltd (UK)0 个研究点目标入组 20 人开始时间: 2008年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- 性别
- All
入选标准
- •1. Males and females aged 18 years and older
- •2. Must fulfil 1980 preliminary classification criteria for systemic sclerosis of the American Rheumatism Association
- •3. Diffuse cutaneous systemic sclerosis, as evidenced by skin sclerosis proximal to the elbows or knees and absence of the anti-centromere autoantibody
- •4. Three years must have elapsed since the first non-Raynaud's manifestation
- •5. Men and women of chilbdearing potential must use adequate birth control measures for the duration of the study and should continue such precautions for six months after receiving the last injection of AIMSPRO®
- •6. Hb >8.5 g/dL
- •7. White blood cell (WBC) >3.5 x 10^9/L
- •8. Platelets >100 x 10^9/L
- •9. Serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and alkaline phosphatatse levels must be within twice the upper limit of normal range
排除标准
- •1. Woman who are pregnant, nursing or planning pregnancy within one and a half years after screening
- •2. Use of any Investigational Medicinal Product (IMP) within one month prior to screening or within five half-lives of the IMP, whichever is longer
- •3. Use of a putative disease modifying drug within one month of screening
- •4. Treatment with any medication targeted at reducing tumour necrotising factor (TNF) within three months of screening
- •5. Previous administration of AIMSPRO®
- •6. History of known allergy to animal proteins
- •7. Serious infections in the last three months
- •8. Active Hepatitis B or C
- •9. Active tuberculosis
- •10. Opportunistic infections within the last six months
- •11. History or suggestive signs of lymphoproliferative disease
- •12. Known recent substance abuse
- •13. Poor tolerability of venesection or poor access
- •14. Presence of a transplanted organ (other than a corneal transplant of >3 months duration)
- •15. Immunosuppressive therapy within one month of screening
- •16. Malignancy within the past five years
- •17. Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurological disease
- •18. Myocardial infarction, uncontrolled cardiac failure, unstable angina or uncontrolled systemic hypotension or hypertension within the past three months
- •19. Screening values which deviate 20% or more from the limits of normal which are considered to be clinically significant by the investigator
研究者
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