A Phase IIIb, Multi-center Open-label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 168
- 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
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
详细描述
Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to Baseline (W0) or worst swollen and tender joints counts), will be given the option to enroll in C87084 and receive certolizumab pegol [400 mg at Entry, Week 2, and Week 4 followed by 200 mg every two weeks (Q2W)] in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region or until further notice from UCB.
All patients will continue their MTX treatment at the same stable dose as during the C87077 (NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity.
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 be able to understand the written Informed Consent Form (ICF)
- •Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
- •Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
- •Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
- •Patients must be willing to comply with protocol
排除标准
- •Patients must not have a diagnosis of any other inflammatory Arthritis
- •Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
- •Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
- •Patients who do not meet the Medical History Exclusion criteria, as defined per protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease
研究组 & 干预措施
CDP870
Patients having completed the week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of RA in the patient's country or region (or until further notice from UCB).
干预措施: Certolizumab pegol (Drug)
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 60 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 date and time is after the first study drug administration in C87084, up to 84 days after the last injection.
Percentage of Subjects Withdrawing From Study Due To A Treatment-emergent Adverse Event (TEAE) During The Study Period
时间窗: From Entry Visit up to approximately 60 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 date and time is after the first study drug administration in C87084, up to 84 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 60 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 C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Percentage of Subjects With ACR50 (American College of Rheumatology 50% Improvement) Response at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Percentage of Subjects With ACR70 (American College of Rheumatology 70% Improvement) Response at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in SDAI (Simplified Disease Activity Index) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in CDAI (Clinical Disease Activity Index) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Percentage of Subjects With DAS28[ESR] (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Percentage of Subjects With SDAI (Simplified Disease Activity Index) Remission (SDAI ≤3.3) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤2.8) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in HAQ-DI (Health Assessment Questionnaire-Disability Index) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in FAS (Fatigue Assessment Scale) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in Physical Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in Role Physical (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in Bodily Pain (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in General Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in Vitality (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in Social Functioning (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in Role Emotional (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in Mental Health (Short Form 36-item Health Survey Domain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in PCS (Short Form 36-item Health Survey Physical Component Summary) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in MCS (Short Form 36-item Health Survey Mental Component Summary) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in PtAAP (Patient's Assessment of Arthritis Pain) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))
- Change From Baseline in PtGADA (Patient's Global Assessment of Disease Activity) at Completion/Withdrawal Visit(Baseline (in C87077 [NCT00580840]) to Completion/Withdrawal Visit (up to approximately 54 weeks))