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临床试验/NCT00554606
NCT00554606已完成2 期

A 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid Arthritis

Novartis1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2007年10月11日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Novartis
入组人数
115
试验地点
1
主要终点
Number of Participants With Adverse Events and Serious Adverse Events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • •Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent

排除标准

  • •Patients for whom continued treatment in the extension is not considered appropriate by the treating physician.
  • •Patients who were non-compliant or who demonstrated a major protocol violation in the core study.
  • •Patients who did not complete / discontinued from the core study.
  • •Patients with drug related serious adverse events or severe adverse events.
  • •Other protocol-defined inclusion/exclusion criteria may apply.

研究组 & 干预措施

Canakinumab

Experimental

Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.

干预措施: Canakinumab (Drug)

结局指标

主要结局

Number of Participants With Adverse Events and Serious Adverse Events

时间窗: From start of the study up to End Of Study (Week 60)

Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.

次要结局

  • Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)(Baseline Up to End Of Study (up to week 60))
  • Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)(Baseline Up to End Of Study (up to week 60))
  • Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)(Baseline Up to End Of Study (up to week 60))
  • Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Erosion Score at Week 18(Baseline, Week 18)
  • Core Study BMD of Total Lumbar Spine, Hip and Hand Was Assessed by DXA at Week 18(Baseline, Week 18)
  • Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)(Baseline Up to End Of Study (up to week 60))
  • Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)(Baseline Up to End Of Study (up to week 60))
  • Change From Baseline in ACR Component : Swollen Joint Count Through Week 54(Baseline Up to End Of Study (up to week 60))
  • Change From Baseline in ACR Component : Tender Joint Count Through Week 54(Baseline Up to End Of Study (up to week 60))
  • Change From Baseline in ACR Component: Patient's Assessment of Pain Activity Through Week 54(Baseline Up to End Of Study (up to week 60))
  • Change From Baseline in ACR Component:- Patient's Global Assessment of Disease Activity Through Week 24(Baseline Up to End Of Study (up to week 60))
  • Change From Baseline in ACR Component : Physician's Global Assessment of Disease Activity Through Week 54(Baseline Up to End Of Study (up to week 60))
  • Change From Baseline in ACR Component : C-reactive Protein (CRP) Through Week 54(Baseline Up to End Of Study (up to week 60))
  • Core Study Change From Baseline in Edema, Erosion and Synovitis Score Was Assessed at Week 18(Baseline, Week 18)
  • Core Study Change From Baseline in Van Der Heijde Modified Total Sharp Score Was Assessed for Joint Narrowing Score at Week 18(Baseline, Week 18)
  • Number of Subjects With Long-term Immunogenicity(Baseline Up to End Of Study (up to week 60))
  • Pharmacokinetic (PK) of ACZ885: Systemic Clearance From Serum Following Intravenous Administration (CL) in Participants(Pre dose at Day 1, Pre dose at week 6, 12, 18, 24, 30, 36, 42, 48, follow up and at study completion (week 60))
  • Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Physical Component)(Baseline Up to End Of Study (up to week 60))
  • Pharmacokinetic (PK) of ACZ885: Volume Distribution From Serum Following Intravenous Administration (CL) in Participants(Pre dose at Day 1, Pre dose at week 6, 12, 18, 24, 30, 36, 42, 48, follow up and at study completion (week 60))
  • Health-Related Quality of Life (HRQoL) Accessed by Short Form (SF) -36 Score (Mental Component)(Baseline Up to End Of Study (up to week 60))
  • Health-Related Quality of Life (HRQoL) Accessed by Health Assessment Questionnaire (HAQ) Score(Baseline Up to End Of Study (up to week 60))

研究者

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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