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临床试验/NCT03502616
NCT03502616已完成3 期

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Pfizer99 个研究点 分布在 6 个国家目标入组 270 人开始时间: 2018年6月7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
270
试验地点
99
主要终点
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16
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相关资讯

研究概览

简要总结

The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

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

  • •Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria for AS (1984).
  • •Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.
  • •Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or intolerant to NSAIDs.

排除标准

  • •History of known or suspected complete ankylosis of the spine.
  • •History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.
  • •History of any other rheumatic disease.
  • •Any subject with condition affecting oral drug absorption.

研究组 & 干预措施

Tofacitinib

Experimental

干预措施: Tofacitinib (Drug)

Placebo

Placebo Comparator

干预措施: Tofacitinib (Drug)

结局指标

主要结局

Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16

时间窗: Week 16

ASAS20 assess 4 domains: Patient Global Assessment of Disease (PGA) (assess disease activity on a scale of 0 \[not active\] to 10 \[very active\], high score=more disease activity), total back pain (scale of 0 \[no pain\] to 10 \[most severe pain\], high score=more severity), Function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]; participant's level of ability on scale of 0 \[easy\] to 10 \[impossible\], low score= better functional health) and Inflammation (morning stiffness, Mean of Question \[Q\]5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] defined as 6-item questionnaire measure disease activity on a scale of 0 \[none\] to 10 \[severe\], high score=more disease activity). ASAS20 response: greater than or equal to (\>=) 20 percent (%) improvement from baseline in disease activity and absolute change of \>=1 unit in \>=3 domains and no worsening of \>=20% and an absolute change of \>=1 unit in remaining domain.

次要结局

  • Percentage of Participants Achieving Ankylosing Spondylitis (ASAS)40 Response at Week 16(Week 16)
  • Number of Participants With Treatment Emergent Adverse Events (AEs)(Baseline up to Week 16 and Baseline up to Week 48)
  • Number of Participants With Vital Signs Abnormalities(Baseline up to Week 16 and Baseline up to Week 48)
  • Number of Participants With Abnormalities in Physical Examination(Screening, Week 16, and Week 48)
  • Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48(Weeks 2, 4, 8, 12, 24, 32, 40 and 48)
  • Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48(Weeks 2, 4, 8, 12, 24, 32, 40 and 48)
  • Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity(Baseline up to Week 16 and Baseline up to Week 48)
  • Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)(Baseline up to Week 16 and Baseline up to Week 48)
  • Number of Participants With Electrocardiogram (ECG) Abnormalities(Baseline up to Week 16, Baseline up to Week 48)
  • Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Weeks 16 and 48(Baseline, Weeks 16 and 48)
  • Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48(Baseline, Weeks 16 and 48)
  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problem at Weeks 16 and 48(Baseline, Weeks 16 and 48)
  • Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 4, 8, 12, 16, 24, 32, 40 and 48)
  • Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48(Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48)
  • Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48(Baseline, Weeks 16 and 48)
  • Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score (mm) at Weeks 16 and 48(Baseline, Weeks 16 and 48)
  • Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Due to Health Problem at Weeks 16 and 48(Baseline, Weeks 16 and 48)
  • Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health Problem at Weeks 16 and 48(Baseline, Weeks 16 and 48)
  • Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Due to Health Problem at Weeks 16 and 48(Baseline, Weeks 16 and 48)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (99)

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