EUCTR2007-003647-75-FI进行中（未招募）不适用
A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis
Merck Serono International0 个研究点目标入组 90 人开始时间: 2007年12月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •The trial will enrol male and female subjects =18 years of age at the time of Informed Consent who have rheumatoid arthritis satisfying American College of Rheumatology criteria and a disease history of at least 12 months. Subjects must have active disease, defined by a DAS28>3.2.
- •Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab: i.e. they must have a documented response after an observation period of at least 16 weeks from initiation of treatment to a previous course of rituximab treatment given at least 24 weeks before SD1 and they must have significant residual active disease after previous rituximab treatment or clinical deterioration after initial response.
- •Residual active disease is defined by a DAS28>3.2 and a clinical deterioration after initial response is defined by an increase in DAS28 of =0.6 or similar benchmarks of minimally acceptable disease activity or change in disease activity.
- •Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for four weeks before SD1, during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and at SD1.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main exclusion criteria are:
- •· Neurological disease.
- •· Inflammatory joint disease other than RA.
- •· Any contraindication to rituximab as per national label.
- •· Known presence of human anti-chimeric antibodies (HACA) to rituximab.
- •· Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen >25 mg/week.
- •· Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer).
- •· Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1.
- •· Active or latent tuberculosis within the year before screening or major infection requiring hospitalisation or intravenous anti-infectives within 28 days before SD1.
- •· Serum IgG below 6 g/L.
- •· Known hypersensitivity to atacicept or to any of the components of the formulated atacicept.
- •· Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins.
- •· Breastfeeding or pregnancy.
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