NCT01040715已完成2 期
A Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFα Biological 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
- 40
- 试验地点
- 48
- 主要终点
- Proportion of patients with at least a 3-fold increase in antibody response to TNFa vs baseline at day 38
研究概览
简要总结
The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously treated with anti-TNFα mAb but have lost susceptibility to therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR) (Arnett 1988) since at least six months prior to first study product administration.
- •Male or female between 18 and 70 years of age at the time of the first immunization
- •Active RA disease as evidenced by a Disease Activity Score 28 (DAS 28) ≥ 3.
- •Current or past treatment with an anti-TNF antagonist (infliximab, adalimumab,etanercept, certolizumab, golimumab).
- •A wash-out period before the first administration of the study product of at least ten weeks since the last administration of certolizumab or golimumab; at least eigth weeks since the last administration of infliximab; at least four weeks since the last administration of adalimumab or etanercept
- •History of positive response defined as an ACR20 or DAS 28 decrease ≥ 1.2 or by the investigator opinion with previous TNFα antagonist treatment.
- •Secondary treatment failure to maximum one previous TNFα antagonist treatment as defined by:
- •Investigator opinion. OR
- •DAS28 increase ≥ 0.6 during the last six months. OR
- •Decrease in European League Against Rheumatoid (EULAR) score.
- •Written informed consent .
排除标准
- •Treatment with non-biological DMARDs within four weeks prior to first study product administration. MTX is allowed provided it is administered at as table dosage < ou = 20 mg/week since at least 4 weeks.
- •Treatment with any rheumatoid arthritis biological therapy other than TNFα antagonists at any time prior to first study product administration.
- •Administration of high doses of intra-articular corticosteroids for the treatment of an acute mono-arthritis (eg knee) within 3 months prior to first study product administration. High dose of corticosteroids is defined as > 50 mg triamcinolone or equivalent.
- •History of documented severe bacterial infection within 28 days prior to first immunization
- •History of primary resistance or intolerance to any TNFα antagonist.
- •History of or current congestive heart failure, controlled or not.
- •Corticosteroids (prednisone or equivalent, < ou = 10 mg per day) are allowed if they are administered at stable dosage since at lesat 4 weeks prior to the first immunization. Inhaled and topical steroids are allowed.
- •Known history of tuberculosis (TB).
- •Suspicion of TB at chest X-rays at screening or within three months prior to first administration of study product.
- •Suspicion of latent or active tuberculosis as defined by :
- •Positive Mantoux/Purified Protein Derivative (PPD)test (> ou = 5mm induration measured 48 to 72 hours after intradermal injection of tuberculin) at screening or within 30 days prior to first administration of study product.
- •and/or positive interferon-γ (IFN γ) TB diagnostic test (as measured by the ELISpot method) at screening or within three months prior to first administration of study product.
- •Positive for HIV, HCV or HBV including HBsAg and anti-HBc antibodies.
- •Use of any investigational or non-registered product (drug or vaccine).
- •Administration of any live vaccine within three months prior to study entry
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
研究组 & 干预措施
TNFa Kinoid dose 2
Experimental
干预措施: TNFa Kinoid (Biological)
TNFa Kinoid dose 2
Experimental
干预措施: TNF kinoid (Biological)
TNFa Kinoid dose 3
Experimental
干预措施: TNFa Kinoid (Biological)
TNFa Kinoid dose 3
Experimental
干预措施: TNF kinoid (Biological)
TNFa Kinoid dose 1
Experimental
干预措施: TNFa Kinoid (Biological)
TNFa Kinoid dose 1
Experimental
干预措施: TNF kinoid (Biological)
结局指标
主要结局
Proportion of patients with at least a 3-fold increase in antibody response to TNFa vs baseline at day 38
时间窗: Day 38
次要结局
- Proportion of patients with a decrease of at least 1.2 in DAS28 at month 3 vs baseline(3 months)
研究者
研究点 (48)
Loading locations...
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