NCT00993317已完成3 期
A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate
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
- 127
- 试验地点
- 15
- 主要终点
- ACR20 Responses at Week 24
研究概览
简要总结
The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.
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
- Triple (Participant, 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
- •Adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria
- •Active RA disease as defined by at least 9 tender joints and 9 swollen joints, ESR of 30 mm/hour or CRP of 1.5 mg/dL
- •MTX (with or without folic acid) for at least 24 weeks prior to the Baseline visit, The dose of MTX and route of administration must have been stable for at least 8 weeks prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.
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)
- •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 (within 24 weeks , including herpes zoster), or any current sign or symptom that may indicate an infection (e.g., fever, cough)
- •High risk of infection
- •Have received any experimental non-biological therapy, within or outside a clinical trial in the 12 weeks prior to Baseline
- •Have received previous B-cell therapy (eg. Rituximab)
- •Have received any other biological therapy for RA within 24 weeks prior to Baseline visit, except for etanercept where a three month washout prior to baseline visit is acceptable
- •Have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
- •Failed to respond to previous treatment with an anti-TNF drug
- •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
Placebo of CDP870+MTX
Placebo Comparator
干预措施: Placebo of CDP870 (Drug)
Placebo of CDP870+MTX
Placebo Comparator
干预措施: Methotrexate (Drug)
CDP870 200mg+MTX
Experimental
干预措施: CDP870 200mg (Drug)
CDP870 200mg+MTX
Experimental
干预措施: Methotrexate (Drug)
结局指标
主要结局
ACR20 Responses at Week 24
时间窗: Week 24
Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.
次要结局
- ACR 20 Responses at Week 12(Week 12)
- ACR50 Responses at Week 12(Week 12)
- ACR70 Responses at Week 12(Week12)
- ACR50 Responses at Week 24(Week 24)
- ACR70 Responses at Week24(Week 24)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline and Week 24)
研究者
研究点 (15)
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