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临床试验/NCT01421069
NCT01421069已完成3 期

AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)

Pfizer35 个研究点 分布在 19 个国家目标入组 109 人开始时间: 2011年10月10日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
109
试验地点
35
主要终点
Number of Participants With Malignancy: All Periods of Parent and Extension Study
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).

研究设计

研究类型
Interventional
分配方式
Na
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 30 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)
  • •Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.

排除标准

  • •Exclusion criteria for subject planning to continue investigational product:
  • •withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).
  • •History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.

研究组 & 干预措施

1

Experimental

干预措施: etanercept (Drug)

结局指标

主要结局

Number of Participants With Malignancy: All Periods of Parent and Extension Study

时间窗: First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)

Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

次要结局

  • Number of Participants With Infections: All Periods of Parent and Extension Study(First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study))
  • Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study(First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study))
  • Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study(First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study))
  • Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period(Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months))
  • Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study(Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months))
  • Number of Participants With Serious Infections: All Periods of Parent and Extension Study(First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study))
  • Number of Participants With Infections: Extension Study: Withdrawal Period(Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months))
  • Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period(Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 withdrawal period of extension study)
  • Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study(First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study))
  • Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study(Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months))
  • Change From Baseline of Parent Study in Z-Score at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study)
  • Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period(Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study)
  • Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period(Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 withdrawal period of extension study)
  • Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period(Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 re-treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 of Extension Study: Active Treatment Period(Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period(Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period:(Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period(Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period(Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Percentage of Participants With Clinically Inactive Disease at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period(Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period(Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period(Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period(Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Exposure Time: Extension Study: Active Treatment Period(Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months))
  • Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants Years at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in C-reactive Protein at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in C-reactive Protein at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline (of Parent Study) in C-reactive Protein at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 of Extension Study: Re-treatment Period(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Percentage of Participants With Clinically Inactive Disease at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Percentage of Participants With Clinically Inactive Disease at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period(Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline (of Parent Study) in Overall Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of Extension study)
  • Change From Baseline (of Parent Study) in Overall Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)(Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Overall Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)(Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)(Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study)
  • Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)(Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study)
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)(Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Percentage Body Surface Area (BSA) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • Change From Baseline (of Parent Study) in Physician's Global Assessment (PGA) of Psoriasis Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)(Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)
  • All Cause Mortality: All Periods of Extension Study(Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months))
  • Number of Participants With Prior Non-study Medication: All Periods of Extension Study(Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months))
  • Number of Participants With Concomitant Non-study Medication: All Periods of Extension Study(Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months))
  • Number of Participants With After Non-study Medication: All Periods of Extension Study(Extension study: Last dose of study medication up to 30 days (maximum up to 97 months))
  • Number of Participants With Vital Signs Abnormalities: Extension Study: Active Treatment Period(Month 96 active treatment period of extension study)
  • Percentage of Participants With Total Childhood Health Assessment Questionnaire (CHAQ) Score Improvement of >0.188 at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period(Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (35)

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