NCT01911234已完成2 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Neovacs
- 入组人数
- 143
- 试验地点
- 32
- 主要终点
- Change in DAS28-CRP between Month 6 and baseline.
研究概览
简要总结
The safety and immunogenicity of the TNF-Kinoid (TNF-K) have been evaluated in a phase II clinical study conducted in subjects with Rheumatoid arthritis. Preliminary results of clinical efficacy are promising.
The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with Rheumatoid arthritis in whom treatment with methotrexate is not working anymore. Subjects who have never been treated with anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has had a diagnosis of RA according to the revised ACR criteria (Aletaha et al. 2010) for at least 6 months.
- •Has been treated with and tolerated MTX for at least 3 months prior to the first administration of study product, - Has at least four swollen joints/66 and/or four tender joints/68,
- •Has CRP ≥ 10 mg/L at screening.
- •Is positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptides (CCP) antibodies at screening.
排除标准
- •Has inflammatory rheumatic disease other than RA
- •Has been treated with non-biological DMARDs/systemic immunosuppressives
- •Has been treated with leflunomide within 12 weeks prior to first administration of study product.
- •Has received intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids
- •Has received infliximab, etanercept, adalimumab, certolizumab, golimumab; another TNFα antagonist; or rituximab prior to the study.
- •Has been treated with any other biological DMARDs
研究组 & 干预措施
TNF-Kinoid
Experimental
TNF Kinoid + ISA51
干预措施: TNF-Kinoid (Biological)
Placebo
Placebo Comparator
Placebo + ISA51
干预措施: Placebo (Other)
结局指标
主要结局
Change in DAS28-CRP between Month 6 and baseline.
时间窗: Month 6
次要结局
- Clinical responses defined as ACR20, ACR50, ACR70, SDAI, EULAR responses, changes in Tender and Swollen joint counts, DAS-28 and HAD-QI versus baseline(Several timepoints during 24 weeks study period)
- Immunogenicity: Anti-TNFα antibodies, Anti-TNFα neutralizing antibody activity, Anti-KLH antibodies by ELISA ; cytokines(Several timepoints during 24 weeks study period)
- Safety assessments will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory evaluations, and the recording of adverse events (AEs)(Several timepoints during 24 weeks study period)
研究者
研究点 (32)
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