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临床试验/NCT03457792
NCT03457792已完成不适用

Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2018年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
158
试验地点
1
主要终点
Number of patients continuing with abatacept treatment

研究概览

简要总结

This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA
  • Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)

排除标准

  • Participants who are currently included in any interventional clinical trial in RA
  • Other protocol defined inclusion/exclusion criteria could apply

结局指标

主要结局

Number of patients continuing with abatacept treatment

时间窗: Up to 12 months

次要结局

  • Clinical disease activity index (CDAI)(Up to 12 months)
  • Reason for abatacept treatment initiation as determined by the investigator(At baseline)
  • Socio-demographics of participants as determined by the investigator(At baseline)
  • Concomitant treatment given with abatacept as determined by the investigator(Up to 12 months)
  • Dosage of abatacept as determined by the investigator(Up to 12 months)
  • Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)(Up to 12 months)
  • Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)(Up to 12 months)
  • Simplified Disease Activity Score (based on 28 joints) (DAS28)(Up to 12 months)
  • Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2(Up to 12 months)
  • Anti-citrullinated protein antibody (ACPA) titer(At baseline)
  • Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)(Up to 12 months)
  • Number of Adverse Events (AE)(Up to 12 months)
  • Evaluator global assessment (EGA)(Up to 12 months)
  • Frequency of administration of abatacept(Up to 12 months)
  • Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2)(Up to 12 months)
  • Patient global assessment (PGA)(Up to 12 months)
  • Disease history of participants as determined by the investigator(At baseline)
  • Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria(Up to 12 months)
  • Number of patients who achieve the first remission state, DAS28 < 2.6(Up to 12 months)
  • Number of Serious Adverse Events (SAE)(Up to 12 months)
  • Existence or the absence of radiographic erosions as determined by the investigator by imaging technique(Up to 12 months)
  • Rheumatoid factor (RF)(Up to 12 months)
  • Health Assessment Questionnaire Disability Index (HAQ-DI)(Up to 12 months)
  • Simple disease activity index (SDAI)(Up to 12 months)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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