A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 402
- 试验地点
- 61
- 主要终点
- Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
研究概览
简要总结
The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. Treatment will continue up to approval of a marketing application for this product.
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
- •Participation in CZP trial C87014 or C87011
- •If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
- •Must have provided written informed consent before undergoing any study procedures
排除标准
- •History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
- •Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
- •Any finding indicative of Tuberculosis at end of previous study
- •Known HIV infection
- •Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (> 2 times upper limit of normal)
- •Hemoglobin (Hgb) levels < 9 g/dL or Hematocrit < 30 %
- •Total White Blood Cell (WBC) count of < 3.0 x 100/L (< 3000/mm^3)
- •Platelet count < 100 x 100 L (100,000/mm^3)
- •Serum creatinine > 1.5 times upper limit of normal based on patient age and sex
- •Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
- •Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
- •Any other condition which the Principal Investigator judges would make patient unsuitable for study participation
研究组 & 干预措施
Certolizumab Pegol
干预措施: Certolizumab Pegol (Biological)
结局指标
主要结局
Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
时间窗: From first dose of CZP up to 8 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 CZP was at Baseline of one of the feeder studies C87011 \[NCT00548834\] or C87014 \[NCT00544154\] for subjects randomized to CZP, or at First 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 Period of 8 Years
时间窗: From First Visit (Week 0 in this study) up to 8 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 316(From Baseline to Week 316)
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208(From Baseline to Week 208)
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100(From Baseline to Week 100)
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit(From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit(From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years)
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52(From Baseline to Week 52)
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160(From Baseline to Week 160)
- Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256(From Baseline to Week 256)
- Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit(From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years)
- Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit(From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years)
- Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years(From First Visit (Week 0 in this study) up to 8 years)
- Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years(From First Visit (Week 0 in this study) up to 8 years)