EUCTR2010-019996-32-CZ进行中（未招募）1 期
A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease
eovacs SA0 个研究点目标入组 132 人开始时间: 2010年11月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female aged 18 to 65 years, inclusive.
- •2.Have had a diagnosis of Crohn’s disease for at least 6 months.
- •3.Moderate to severe active Crohn’s disease defined as a Crohn’s Disease Activity Index (CDAI) score = 220 and = 450, and presence of mucosal ulcerations in at least 2 segments, or ulcerations on = 10% of the mucosal surface if only one segment is involved.
- •4.Either have developed secondary resistance to one or two anti-TNFa therapy. Secondary resistance must have followed at least 6 months of continuous anti-TNFa therapy during which a positive clinical response has been observed, according to the Investigator.
- •Have developed intolerance to one or two anti-TNFa treatment, provided that the observed adverse events are thought to be unrelated to the primary pharmacological effect of these agents (i.e. TNFa blockade). Subjects can have received only one or more anti-TNF-a agent, and must have discontinued this treatment as follows:
- •Infliximab: a wash-out period of 8 weeks prior to the first administration of study drug;
- •Adalimumab: a wash-out period of 4 weeks prior to the first administration of study drug;
- •Certolizumab: a wash-out period of 8 weeks prior to the first administration of study drug;
- •5.If receiving the medications listed below, must meet the outlined criteria:
- •Systemic corticosteroids: up to 25 mg/day of prednisone or equivalent, ongoing for at least 8 weeks, and with a stable dose for at least 2 weeks prior to the first administration of study drug;
- •Budesonide: up to 6 mg/day, ongoing for at least 8 weeks, and with a stable dose for at least 2 weeks prior to the first administration of study drug;
- •Methotrexate: up to 25 mg/week, ongoing for at least 8 weeks, and with a stable dose for at least 4 weeks prior to the first administration of study drug;
- •Azathioprine: up to 2.5 mg/kg/day, ongoing for at least 8 weeks, and with a stable dose for at least 4 weeks prior to the first administration of study drug;
- •Mercaptopurine: up to 1.5 mg/kg/day, ongoing for at least 8 weeks, and with a stable dose for at least 4 weeks prior to the first administration of study drug;
- •Antibiotics (metronidazole at 15-20 mg/kg per day and/or ciprofloxacin 500 mg bid) are allowed if ongoing for at least 4 weeks, and with a stable dose for at least 2 weeks prior to the first administration of study drug;
- •Sulfasalazine and mesalazine ongoing for at least 8 weeks, and with a stable dose of maximum 4g per day for at least 4 weeks prior to the first administration of study drug
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 132
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Primary non-response to a previously received treatment directed against TNF a
- •Intolerance related to the primary pharmacological effect of anti-TNF-a such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
- •2.History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
- •3.Treatment with more than 2 doses over 30 mg of rectally administered corticosteroids in the 14 days preceding the first administration of study drug.
- •4.Treatment with immunosuppressive or immunomodulatory drugs, including, but not limited to:
- •B-cell depleting therapy (e.g., anti-CD20, anti-CD22) within 1 year of the first administration of study drug;
- •Cyclophosphamide within 12 weeks of the first administration of study drug;
- •Cyclosporine within 12 weeks of the first administration of study drug;
- •TNFa blockers other than infliximab, adalimumab or certolizumab within 12 weeks or 5 half lives of the first administration of study drug, whichever is longer
- •Biological agents other than TNF-a blockers within 12 weeks or 5 half lives of the first administration of study drug, whichever is longer.
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