A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 857
- 试验地点
- 121
- 主要终点
- Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
研究概览
简要总结
An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).
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
- •Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the entire Week 52 assessment of C87027 [NCT00152386] trial.
排除标准
- •A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
- •A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
- •Any concomitant biological therapy
- •Any experimental therapy, within or outside a clinical trial
结局指标
主要结局
Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
时间窗: From first dose of CZP to the end of the open-label study (approximately 7 years)
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study \[NCT00152386\] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
时间窗: From first dose of CZP to the end of the open-label study (approximately 7 years)
A SAE is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above First dose of CZP was at Baseline of the preceding double-blind study \[NCT00152386\] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
时间窗: From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
次要结局
- Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96(From Baseline of the preceding double-blind study to Week 96 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144(From Baseline of the preceding double-blind study to Week 144 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192(From Baseline of the preceding double-blind study to Week 192 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240(From Baseline of the preceding double-blind study to Week 240 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))
- Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48(From Baseline of the preceding double-blind study to Week 48 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48(From Baseline of the preceding double-blind study to Week 48 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96(From Baseline of the preceding double-blind study to Week 96 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144(From Baseline of the preceding double-blind study to Week 144 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192(From Baseline of the preceding double-blind study to Week 192 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240(From Baseline of the preceding double-blind study to Week 240 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))
- Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48(From Baseline of the preceding double-blind study to Week 48 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96(From Baseline of the preceding double-blind study to Week 96 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144(From Baseline of the preceding double-blind study to Week 144 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192(From Baseline of the preceding double-blind study to Week 192 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240(From Baseline of the preceding double-blind study to Week 240 of the open-label study)
- Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))
- Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)(From Baseline of the preceding double-blind study to Week 96 of the open-label study)
- Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))
- Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))
- Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))
- Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))
- Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))
- Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score(From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years))