A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 194
- 试验地点
- 31
- 主要终点
- Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24
研究概览
简要总结
To assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (DMARDs) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis
详细描述
Treatment period starts with a 24-week, double blind, placebo-controlled, randomized period followed by an open label phase until week 52.
In the double blind phase eligible patients will be randomized via an Interactive Voice Response System (IVRS) in a 1:1 ratio to receive either certolizumab pegol (400 mg at Weeks 0, 2 and 4, followed by 200 mg every two weeks) or placebo up to and including Week 22. All patients will continue to receive their Disease Modifying AntiRheumatic Drugs (DMARDs) therapy established before study entry until Week 52. At Week 24, patients will not receive any injection but will be evaluated:
- Non-remitters at Week 24 (patients who did not achieve remission at both Week 20 and Week 24) will be discontinued from the study and may be given the opportunity to enter in an open-label follow-up trial, C87080 [NCT00843778], with certolizumab pegol.
- Remitters (i.e. patients who achieved remission as measured by Clinical Disease Activity Index (CDAI) at both Week 20 and Week 24) will stop their randomized treatment (certolizumab pegol or placebo) and be followed up until Week 52. Remitters who flare up (CDAI ≥11 confirmed at two consecutive visits four weeks apart) between Week 24 and Week 52 will be re-treated with the same dosing regimen of certolizumab pegol (3 administrations of 400mg, given every 2 weeks, followed by 200 mg given every other week) up to and including Week 50.
Remitters who flare up between Week 24 and Week 52 and complete 52-week study period will be allowed to enter open label follow up trial at Week 52.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 diagnosis of low to moderate adult rheumatoid arthritis, currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six months and not longer than 10 years
排除标准
- •All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient
- •Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
- •Patients must not have received any previous biological therapy for rheumatoid arthritis (RA)
结局指标
主要结局
Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24
时间窗: Week 20 and Week 24
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)
次要结局
- 28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24(Week 20 and Week 24)
- Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24(Week 20 and Week 24)
- Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits(Week 24 up to Week 52)
- Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits(Week 24 up to Week 52)
- Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits(Week 24 up to Week 52)
- American College of Rheumatology 20% (ACR20) Response at Week 24(Baseline, Week 24)
- American College of Rheumatology 50% (ACR50) Response at Week 24(Baseline, Week 24)
- American College of Rheumatology 70% (ACR70) Response at Week 24(Baseline, Week 24)
- Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24(Baseline, Week 24)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24(Baseline, Week 24)
- Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24(Baseline, Week 24)
- Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24(Baseline, Week 24)
- Change From Baseline in Fatigue Assessment Scale at Week 24(Baseline, Week 24)