A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 851
- 试验地点
- 1
- 主要终点
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
研究概览
简要总结
The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.
详细描述
The study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period.
At or after week 24, participants with an inadequate response could receive rescue therapy with etanercept plus methotrexate until the end of the treatment period.
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
- •Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
- •Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.
- •Subject has an active psoriatic skin lesion
- •Subject is naïve to etanercept and any other biologic for the treatment for PsA or psoriasis.
- •Subject has no prior use of methotrexate for PsA.
- •Subject has no history of tuberculosis
- •Subject has a negative test for tuberculosis, hepatitis B and C.
排除标准
- •Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.
- •Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product.
- •Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.
研究组 & 干预措施
Etanercept Monotherapy
Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
干预措施: Etanercept (Drug)
Methotrexate Monotherapy
Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
干预措施: Methotrexate (Drug)
Methotrexate Monotherapy
Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
干预措施: Placebo to Etanercept (Drug)
Etanercept Monotherapy
Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
干预措施: Placebo to Methotrexate (Drug)
Methotrexate + Etanercept
Participants received etanercept 50 mg a week by subcutaneous injection plus oral methotrexate 20 mg weekly for 48 weeks.
干预措施: Etanercept (Drug)
Methotrexate + Etanercept
Participants received etanercept 50 mg a week by subcutaneous injection plus oral methotrexate 20 mg weekly for 48 weeks.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
时间窗: Baseline and week 24
A positive ACR20 response is defined 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: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein concentration.
次要结局
- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Tender Joint Count Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Physician Global Assessment of Disease Activity Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24(Week 24)
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Swollen Joint Count Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24(Baseline and week 24)
- Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24(Baseline and week 24)
- Percentage of Participants With Clear mNAPSI at Week 24(Baseline and week 24)
- Change From Baseline in Leeds Dactylitis Index (LDI) at Week 24(Baseline and week 24)
- Change From Baseline in Patient Global Assessment of Disease Activity Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Patient Global Assessment of Joint Pain Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in C-reactive Protein Concentration Over Time(Baseline and weeks 4, 8, 12, 16, 24, 36, and 48)
- Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time(Baseline and weeks 12, 24, 36, and 48)
- Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24(Baseline and week 24)
- Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups(Baseline and week 24)
- Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups(Week 24)
- Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time(Weeks 4, 8, 12, 24, 36, and 48)
- Percentage of Participants With Clear LDI at Week 24(Baseline and week 24)
- Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24(Baseline and week 24)
- Static Physician Global Assessment (sPGA) at Week 24(Week 24)
- Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24(Baseline and week 24)
- Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24(Baseline and week 24)
- Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24(Baseline and week 24)
- Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24(Week 24)
- Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups(Week 24)
- Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups(Baseline and week 24)
- Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups(Baseline and week 24)
- Mean Static Physician Global Assessment (sPGA) Score at Week 24(Week 24)
- Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24(Baseline and week 24)
- Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups(Week 24)