NCT01197066已完成3 期
A Phase Ⅲ Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters.
研究概览
简要总结
This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
- •Have a clear chest X-ray at the Entry visit
- •Negative urine pregnancy test at the Entry
- •Continue treatment on methotrexate
排除标准
- •Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
- •Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
- •At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
- •NYHA (New York Heart Association) Class III or IV congestive heart failure
- •Current or history of tuberculosis
- •History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
- •History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
- •High risk of infection
- •Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug
研究组 & 干预措施
Certolizumab Pegol
Other
Single Arm
干预措施: Certolizumab Pegol (Drug)
结局指标
主要结局
To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters.
时间窗: Up to 7 years
Treatment will continue until the drug is commercially available in the country.
次要结局
- To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.(Up to 7 years)
- Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36)(Up to 7 years)
- To assess the achievement of clinical remission measured by DAS28.(Up to 7 years)
- The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).(Up to 7 years)
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