A Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 131
- 试验地点
- 25
- 主要终点
- Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period
研究概览
简要总结
To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)
详细描述
This is a Phase IIIB, multi-centre, open-label, follow-up study to study C87076 [NCT00674362] designed to continue to assess the safety and efficacy of Certolizumab Pegol.
Two different population will enter the study from C87076 [NCT00674362] and will be treated with Certolizumab Pegol every two weeks until it is commercially available for the indication of Rheumatoid Arthritis (RA) in the subject's country or region or until further notice from UCB:
Population 1: Are those subjects who failed to achieve remission at Week 20 and/or Week 24 and who completed the Week 24 assessment of study C86076 [NCT00674362].The Week 24 assessment (visit 14) of C87076 [NCT00674362] will also be the entry assessment (visit 1) for C87080. The subjects will receive Certolizumab Pegol 200 mg every two weeks. No induction period will be applied to ensure the blinding of study C87076 [NCT00674362].
Population 2: Are those subjects who achieved remission at both Week 20 and Week 24, flared up between Week 24 and Week 52 and completed the Week 52 assessment in study C87076 [NCT00674362]. The Week 52 assessment (visit 26) of C87076 [NCT00674362] will also be the entry assessment (visit 1) for C87080.
Subjects who flared prior to Week 48 in the C87076 [NCT00674362] study will receive Certolizumab Pegol 200 mg every two weeks in the C87080 study.
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 with established adult rheumatoid arthritis on Disease Modifying Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and:
- •either failed to achieve remission after 6 months of study treatment
- •or flared after the 6 months of study treatment and completed the study (C87076 [NCT00674362])
排除标准
- •All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
- •Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
结局指标
主要结局
Percentage of Subjects Reporting At Least One Treatment-emergent Adverse Event (TEAE) During The Study Period
时间窗: From Entry Visit up to approximately 144 weeks
A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. A TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). TEAEs are all AEs in which the onset and time is after the first study drug administration in C87080, up to 70 days after the last injection.
Percentage of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) During The Study Period
时间窗: From Entry Visit up to approximately 144 weeks
A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
次要结局
- Percentage of Subjects With ACR20 (American College of Rheumatology 20 % Improvement) Response at Completion/Withdrawal Visit(Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136))
- Percentage of Subjects With ACR70 (American College of Rheumatology 70 % Improvement) Response at Completion/Withdrawal Visit(Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136))
- Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 2(Week 2)
- Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit(Completion/Withdrawal Visit (up to approximately Week 136))
- Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit(Completion/Withdrawal Visit (up to approximately Week 136))
- Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit(Completion/Withdrawal Visit (up to approximately Week 136))
- Percentage of Subjects With ACR50 (American College of Rheumatology 50 % Improvement) Response at Completion/Withdrawal Visit(Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136))
- Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit(Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136))
- Percentage of Subjects Willing to Self-inject at Week 0(Week 0 of this study (C87080 [NCT00843778]))
- Mean PRE-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0(Week 0 of this study (C87080 [NCT00843778]))
- Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit(Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136))
- Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit(Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to Week approximately 136))
- Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit(Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136))
- Geometric Mean of Plasma Concentration of Certolizumab Pegol at Week 24 Visit(Week 24)
- Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 0(Week 0 of this study (C87080 [NCT00843778]))
- Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 10(Week 10)
- Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12(Week 12)
- Percentage of Subjects With Positive Anti-Certolizumab Pegol (CZP) Antibody Status at Any Time From Baseline of the Feeder Study C87076 to the Completion/Withdrawal Visit of the Extension Study(Baseline in the feeder study (C87076 [NCT00674362]) to Completion/Withdrawal Visit in the extension study (up to approximately Week 136))
- Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 6(Week 6)
- Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 4(Week 4)
- Mean POST-Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 8(Week 8)
- Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 0(Week 0)
- Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 4(Week 4)
- Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 6(Week 6)
- Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 8(Week 8)
- Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 2(Week 2)
- Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 10(Week 10)
- Mean Injection Site Reaction Questionnaire (ISRQ) Score at Week 12(Week 12)