A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered in Combination With Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-001)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 285
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as add-on medication to methotrexate over the long term in Japanese RA patients transferred from Study 275-08-001 (NCT00791999), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-001.
详细描述
This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.
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
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who participated in Study 275-08-001 and meet all of the criteria described below.
- •Patients who did not reach ACR20, and prematurely discontinued Study 275-08-001 at Week 16 or completed Study 275-08-001 by Week
- •Patients who are able to receive treatment with MTX, by Week 52.
排除标准
- •Patients who experienced an important protocol deviation as mentioned below during Study 275-08-
- •Patients who received live or attenuated vaccines during Study 275-08-001(Except for influenza or pneumococcal vaccines).
- •Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-
- •Patients who required treatment for the same infection at two or more different times during Study 275-08-001
- •Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
- •Patients whom the investigator has decided to be inappropriate for participation in the study
研究组 & 干预措施
Certolizumab pegol 200 mg
Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
干预措施: Certolizumab pegol (Drug)
Certolizumab pegol 200 mg
Participants received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
干预措施: Methotrexate (Drug)
Certolizumab pegol 400 mg
Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
干预措施: Certolizumab pegol (Drug)
Certolizumab pegol 400 mg
Participants received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks.
An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-001. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.
次要结局
- Percentage of Participants With American College of Rheumatology 70% (ACR70) Response(Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks))
- Change From Baseline in Modified Total Sharp Score (mTSS)(Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100)
- Change From Baseline in Disease Activity Score (DAS) 28(Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks))
- Percentage of Participants With American College of Rheumatology 20% (ACR20) Response(Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks))
- Percentage of Participants With American College of Rheumatology 50% (ACR50) Response(Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks))