EUCTR2010-019996-32-HU进行中（未招募）不适用
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: 2011年1月31日最近更新:
试验速览
- 阶段
- 不适用
- 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 colonic mucosal ulcerations in at least 2 segments, or ulcerations on = 10% of the mucosal surface if only one segment is involved.
- •4.Have developed secondary resistance to anti-TNF-a 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. Subjects can have received only one 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;
- •Have developed intolerance to an anti-TNF-a treatment, provided that the observed adverse events are thought to be unrelated to the primary pharmacological effect of these agents (i.e. TNF-a blockade).
- •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
- •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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