NCT01261403终止2 期
A Phase 2, Randomized, Double- Blind, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Active Rheumatoid Arthritis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 16
- 主要终点
- Number/Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response within 12 weeks following the initial dose of study drug
研究概览
简要总结
The primary objective of the study is to assess the safety and efficacy of 2 dose groups (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary objectives of the study are to determine the clinical response at defined visit intervals, determine the time to flare of RA symptoms and to quantify changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Diagnosis of RA as defined by the 1987-revised ACR criteria.
- •RA, characterized by at least 6 out of 66 swollen joints and 6 out of 68 tender joints at Screening and Baseline, and at least 2 of the following: a C reactive protein level (CRP), greater than the upper limit of normal (ULN) ³ 1 mg/dl, an erythrocyte sedimentation rate (ESR) of at least 28 mm per hour, or morning stiffness lasting longer than 45 minutes.
- •Non responsive or intolerant to a minimum of 2 RA therapies which are classified as DMARDs, biologics, or corticosteroids.
- •Biological medication must be discontinued 30 day prior to the first dose of study drug, except golimumab and actemra which are 60 days, and infliximab, alefacept and efalizumab, which must have been discontinued 90 days prior to the first dose of IP.
- •Cytotoxic agents, including but not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents must have been discontinued 90 days prior to the first dose of IP.
- •Subjects must be able to tolerate intravenous infusions in both arms.
- •There should be no change in RA medication dose anticipated during the initial treatment and re treatment periods and the respective 12 week follow-up period for each dosing treatment period. The following rules apply for anti-rheumatic medications taken during the study:
- •DMARDs must have must have been stable for least 90 days prior to dosing with IP.
- •Low -dose corticosteroids are permitted (prednisolone ≤ 10 mg per day or equivalent). Corticosteroids must have been stable for at least 30 days prior to dosing with IP.
- •DMARDs and corticosteroids must remain stable throughout the initial 3 months of study and throughout subsequent treatment periods
- •The presence of any of the following will exclude a subject from enrollment:
- •Prior use of rituximab and other B-cell depleting therapies, abatacept, prior use of more than 2 biologic therapies.
- •Subject has received an investigational agent in any indication-within 60 days (or 5 half-lives, whichever is longer) prior to treatment with IP.
- •Subject has received previous cell therapy.
- •Serum creatinine concentration > 2.0 mg/dl at screening.
- •Alkaline phosphatase > 2.5x the upper limit of normal at screening.
- •Bilirubin level > 1.5 mg/dL (unless subject has known Gilbert's disease).
- •Untreated chronic infection or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP.
- •Positive HIV test at Screening. Positive Hepatitis B surface antigen at Screening. Positive Hepatitis C antibody at Screening.
- •Organic heart disease (e.g., congestive heart failure), myocardial infarction within six (6) months prior to screening or clinically significant findings on ECG at screening. Clinically significant arrhythmia.
- •Primary or secondary immunodeficiency.
排除标准
- 未提供
研究组 & 干预措施
Group 1
Experimental
1 Unit of PDA001 or 4 units Vehicle Control intravenous on Day 0 and Day 7
干预措施: PDA001 (Biological)
Group 1
Experimental
1 Unit of PDA001 or 4 units Vehicle Control intravenous on Day 0 and Day 7
干预措施: Vehicle Controlled Placebo (Drug)
Group 2
Experimental
4 Units PDA001 or 4 units Vehicle Control intravenous (Placebo) on Day 0 and Day 7
干预措施: PDA001 (Biological)
Group 2
Experimental
4 Units PDA001 or 4 units Vehicle Control intravenous (Placebo) on Day 0 and Day 7
干预措施: Vehicle Controlled Placebo (Drug)
Vehicle control
Placebo Comparator
Placebo - Vehicle Control Arm
干预措施: Vehicle Controlled Placebo (Drug)
结局指标
主要结局
Number/Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response within 12 weeks following the initial dose of study drug
时间窗: Baseline through Week 12
A participant is a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]) o Patient's global assessment of disease activity (measured on a 100 mm VAS) o Physician's global assessment of disease activity (measured on a 100 mm VAS) o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)) o C-Reactive Protein
次要结局
- Number/Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at 6 months(Baseline and 6 months)
- Number/percent of subjects achieving an ACR 20 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.(Baseline and each scheduled visit through 12 months following the first infusion of study drug)
- Number/percent of subjects achieving an ACR 50 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.(Baseline and each scheduled visit through 12 months following the first infusion of study drug.)
- Number/percent of subjects achieving an ACR 70 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.(Baseline and each scheduled visit through 12 months following the first infusion of study drug.)
- Number/percent of subjects achieving a clinical response based on their Clinical Disease Activity Index (CDAI) at each scheduled visit during the first 12 months following the first infusion of study drug.(Baseline and each scheduled visit through 12 months following the first infusion of study drug)
- Number/percent of subjects achieving a clinical response based on their Disease Activity Score (DAS 28) score at each scheduled visit during the first 12 months following the first infusion of study drug(Baseline and each scheduled visit through 12 months following the first infusion of study drug)
- Number/Percent of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Month 12(Baseline and each scheduled visit through 12 months following the first infusion of study drug.)
- The change from baseline in the ACR core components. ACR Core Component #1: Percentage Change From Baseline in the Swollen Joint Count at each scheduled visit.(Baseline and each scheduled visit through 12 months following the first infusion of study drug)
- ACR Core Component #2: Percentage Change From Baseline in the Swollen Joint Count at each scheduled visit through Month 12 following the initial infusion of study drug(Baseline and at each scheduled visit through Month 12 following the initial infusion of study drug)
- ACR Core Component #3 Percentage Change From Baseline in the Subject Assessment of Pain at each scheduled visit through Month 12 following the initial dose of study drug(Baseline and at each scheduled visit through Month 12 following the initial dose of study drug)
- ACR component #4 Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at each scheduled visit through Month 12 following the initial dose of study drug(Baseline and at each scheduled visit through Month 12 following the initial dose of study drug)
- ACR Component #5 Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at each scheduled visit through Month 12 following the initial dose of study drug(Baseline and Month 12)
- ACR Component #6; Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at each scheduled visit through Month 12 following the initial dose of study drug(Baseline and at each scheduled visit through Month 12 following the initial dose of study drug)
- ACR Component#7 Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at each scheduled visit through Month 12 following the initial dose of study drug(Baseline at each scheduled visit through Month 12 following the initial dose of study drug)
- ACR Component #8 Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at each scheduled visit through Month 12 following the initial dose of study drug(Baseline and at each scheduled visit through Month 12 following the initial dose of study drug)
- Change from baseline in rheumatoid factors at each scheduled visit through Month 12 following the initial dose of study drug(Baseline and each scheduled visit through Month 12 following the initial dose of study drug)
- Time to flare of Rheumatoid Arthritis (RA) symptoms(At defined intervals)
- Changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6(At defined intervals)
- Change From Baseline in the Disease Activity Score 28 (DAS 28) Using CRP(Baseline and Month 6)
- Change From Baseline in the Clinical Disease Activity Index (CDAI) at Month 3(Baseline and Month 3)
- Change From Baseline in the Clinical Disease Activity Index (CDAI) at Month 6(Baseline and Month 6)
研究者
研究点 (16)
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