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A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

2012년 12월 6일 업데이트: Pfizer

Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

795

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Maroussi Athens, 그리스, 15126
        • Pfizer Investigational Site
  • 덴마크
      • Frederiksberg, 덴마크, 2000
        • Pfizer Investigational Site
  • 독일
      • Berlin, 독일, 14059
        • Pfizer Investigational Site
      • Dresden, 독일, 01067
        • Pfizer Investigational Site
      • Hamburg, 독일, 22081
        • Pfizer Investigational Site
      • Leipzig, 독일, 04103
        • Pfizer Investigational Site
      • Nuernberg, 독일, 90429
        • Pfizer Investigational Site
      • Rheine, 독일, 48431
        • Pfizer Investigational Site
  • 러시아 연방
      • Moscow, 러시아 연방, 115093
        • Pfizer Investigational Site
      • Moscow, 러시아 연방, 115446
        • Pfizer Investigational Site
      • Petrozavodsk, 러시아 연방, 185019
        • Pfizer Investigational Site
  • 말레이시아
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, 말레이시아, 70300
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, 말레이시아, 68100
        • Pfizer Investigational Site
      • Subang Jaya, Selangor, 말레이시아, 47500
        • Pfizer Investigational Site
    • Wilayah Persekutuan
      • Putrajaya, Wilayah Persekutuan, 말레이시아, 62250
        • Pfizer Investigational Site
  • 멕시코
    • Coahuila
      • Torreon, Coahuila, 멕시코, 27000
        • Pfizer Investigational Site
    • Michoacan
      • Morelia, Michoacan, 멕시코, 58249
        • Pfizer Investigational Site
    • Morelos
      • Cuernavaca, Morelos, 멕시코, 62270
        • Pfizer Investigational Site
    • Queretaro
      • Mexico, Queretaro, 멕시코, 76178
        • Pfizer Investigational Site
    • Yucatan
      • Merida, Yucatan, 멕시코, 97000
        • Pfizer Investigational Site
  • 미국
    • Alabama
      • Huntsville, Alabama, 미국, 35801
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, 미국, 72401
        • Pfizer Investigational Site
    • California
      • Palo Alto, California, 미국, 94304
        • Pfizer Investigational Site
      • Stanford, California, 미국, 94305
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, 미국, 80304
        • Pfizer Investigational Site
      • Denver, Colorado, 미국, 80206
        • Pfizer Investigational Site
    • Connecticut
      • Danbury, Connecticut, 미국, 06810
        • Pfizer Investigational Site
      • Hamden, Connecticut, 미국, 06518
        • Pfizer Investigational Site
      • Trumbull, Connecticut, 미국, 06611
        • Pfizer Investigational Site
    • Florida
      • New Port Richey, Florida, 미국, 34652
        • Pfizer Investigational Site
      • Ocala, Florida, 미국, 34474
        • Pfizer Investigational Site
      • Plantation, Florida, 미국, 33324
        • Pfizer Investigational Site
      • Port Richey, Florida, 미국, 34668
        • Pfizer Investigational Site
      • Tamarac, Florida, 미국, 33321
        • Pfizer Investigational Site
      • Tampa, Florida, 미국, 33613
        • Pfizer Investigational Site
    • Georgia
      • Decatur, Georgia, 미국, 30033
        • Pfizer Investigational Site
      • Marietta, Georgia, 미국, 30060
        • Pfizer Investigational Site
    • Illinois
      • Maywood, Illinois, 미국, 60153
        • Pfizer Investigational Site
      • Oakbrook Terrace, Illinois, 미국, 60181
        • Pfizer Investigational Site
      • Rockford, Illinois, 미국, 61103-3692
        • Pfizer Investigational Site
      • Springfield, Illinois, 미국, 62702
        • Pfizer Investigational Site
      • Springfield, Illinois, 미국, 62703
        • Pfizer Investigational Site
      • Vernon Hills, Illinois, 미국, 60061
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, 미국, 47714
        • Pfizer Investigational Site
      • Indianapolis, Indiana, 미국, 46227
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, 미국, 67203
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, 미국, 40505
        • Pfizer Investigational Site
    • Massachusetts
      • Leominster, Massachusetts, 미국, 01453
        • Pfizer Investigational Site
      • Worcester, Massachusetts, 미국, 01605
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, 미국, 55435
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, 미국, 68516
        • Pfizer Investigational Site
    • New York
      • Albany, New York, 미국, 12206
        • Pfizer Investigational Site
      • Orchard Park, New York, 미국, 14127
        • Pfizer Investigational Site
      • Rochester, New York, 미국, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, 미국, 28801
        • Pfizer Investigational Site
      • Charlotte, North Carolina, 미국, 28210
        • Pfizer Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, 미국, 18015
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, 미국, 19610
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, 미국, 29601
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, 미국, 37909
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, 미국, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, 미국, 75235
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, 미국, 98133
        • Pfizer Investigational Site
      • Tacoma, Washington, 미국, 98405
        • Pfizer Investigational Site
      • Tacoma, Washington, 미국, 98405-2308
        • Pfizer Investigational Site
    • West Virginia
      • Clarksburg, West Virginia, 미국, 26301
        • Pfizer Investigational Site
  • 베네수엘라
    • DC/ Municipio Libertados
      • Caracas, DC/ Municipio Libertados, 베네수엘라, 1040-A
        • Pfizer Investigational Site
    • Distrito Capital
      • Caracas, Distrito Capital, 베네수엘라, 1010
        • Pfizer Investigational Site
  • 스웨덴
      • Falun, 스웨덴, 791 82
        • Pfizer Investigational Site
      • Goteborg, 스웨덴, 413 46
        • Pfizer Investigational Site
      • Uppsala, 스웨덴, 751 85
        • Pfizer Investigational Site
  • 스페인
      • A Coruña, 스페인, 15006
        • Pfizer Investigational Site
      • Madrid, 스페인, 28046
        • Pfizer Investigational Site
      • Malaga, 스페인, 29009
        • Pfizer Investigational Site
      • Sevilla, 스페인, 41013
        • Pfizer Investigational Site
    • A Coruña
      • Santiago de Compostela, A Coruña, 스페인, 15705
        • Pfizer Investigational Site
  • 슬로바키아
      • Nove Zamky, 슬로바키아, 94001
        • Pfizer Investigational Site
      • Poprad, 슬로바키아, 058 01
        • Pfizer Investigational Site
      • Povazska Bystrica, 슬로바키아, 017 01
        • Pfizer Investigational Site
      • Rimavska Sobota, 슬로바키아, 979 01
        • Pfizer Investigational Site
      • Senica, 슬로바키아, 905 01
        • Pfizer Investigational Site
      • Zilina, 슬로바키아, 010 01
        • Pfizer Investigational Site
  • 영국
      • Newcastle Upon Tyne, 영국, NE1 4LP
        • Pfizer Investigational Site
    • Merseyside
      • Wirral, Merseyside, 영국, CH49 5PE
        • Pfizer Investigational Site
    • Staffs
      • Cannock, Staffs, 영국, WS11 2XY
        • Pfizer Investigational Site
    • West Midlands
      • Solihull, West Midlands, 영국, B91 2JL
        • Pfizer Investigational Site
  • 중국
      • Beijing, 중국, 100853
        • Pfizer Investigational Site
      • Beijing, 중국, 100020
        • Pfizer Investigational Site
      • Beijing, 중국, 100044
        • Pfizer Investigational Site
      • Shanghai, 중국, 200001
        • Pfizer Investigational Site
      • Shanghai, 중국, 200433
        • Pfizer Investigational Site
      • Shanghai, 중국, 200003
        • Pfizer Investigational Site
      • Tianjin, 중국, 300052
        • Pfizer Investigational Site
    • Anhui
      • Hefei, Anhui, 중국, 230022
        • Pfizer Investigational Site
      • Hefei, Anhui, 중국, 230001
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510630
        • Pfizer Investigational Site
      • Guangzhou, Guangdong, 중국, 510260
        • Pfizer Investigational Site
    • Hubei
      • Wuhan, Hubei, 중국, 430030
        • Pfizer Investigational Site
    • Hunan
      • Changsha, Hunan, 중국, 410008
        • Pfizer Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, 중국, 210029
        • Pfizer Investigational Site
      • Suzhou, Jiangsu, 중국, 215006
        • Pfizer Investigational Site
    • Shandong
      • Jinan, Shandong, 중국, 250012
        • Pfizer Investigational Site
      • Qingdao, Shandong, 중국, 266011
        • Pfizer Investigational Site
    • Shanxi
      • Xi'an, Shanxi, 중국, 710032
        • Pfizer Investigational Site
    • Sichuan
      • Chengdu, Sichuan, 중국, 610041
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310009
        • Pfizer Investigational Site
  • 칠레
      • Vina del Mar, 칠레, 2570017
        • Pfizer Investigational Site
    • RM
      • Santiago, RM, 칠레, 7510186
        • Pfizer Investigational Site
      • Santiago, RM, 칠레, 8360156
        • Pfizer Investigational Site
    • Santiago, RM
      • Providencia, Santiago, RM, 칠레, 7530206
        • Pfizer Investigational Site
    • V Region
      • Vina del Mar, V Region, 칠레, 2570017
        • Pfizer Investigational Site
  • 콜롬비아
    • Atlantico
      • Barranquilla, Atlantico, 콜롬비아, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, 콜롬비아
        • Pfizer Investigational Site
    • Santander
      • Bucaramanga, Santander, 콜롬비아
        • Pfizer Investigational Site
  • 크로아티아
      • Opatija, 크로아티아, 51410
        • Pfizer Investigational Site
      • Zagreb, 크로아티아, 10000
        • Pfizer Investigational Site
  • 태국
    • Bangkok
      • Rajathevee, Bangkok, 태국, 10400
        • Pfizer Investigational Site
    • Chiang Mai
      • Amphoe Muang, Chiang Mai, 태국, 50200
        • Pfizer Investigational Site
    • Khonkaen
      • Muang District, Khonkaen, 태국, 40002
        • Pfizer Investigational Site
  • 폴란드
      • Bialystok, 폴란드, 15-337
        • Pfizer Investigational Site
      • Bialystok, 폴란드, 15-461
        • Pfizer Investigational Site
      • Koscian, 폴란드, 64-000
        • Pfizer Investigational Site
      • Poznan, 폴란드, 60-773
        • Pfizer Investigational Site
      • Torun, 폴란드, 87-100
        • Pfizer Investigational Site
  • 핀란드
      • Helsinki, 핀란드, 00120
        • Pfizer Investigational Site
      • Hyvinkaa, 핀란드, 05800
        • Pfizer Investigational Site
      • Tampere, 핀란드, 33520
        • Pfizer Investigational Site
  • 호주
    • New South Wales
      • Campsie, New South Wales, 호주, 2194
        • Pfizer Investigational Site
    • Queensland
      • Cairns, Queensland, 호주, 4870
        • Pfizer Investigational Site
      • Maroochydore, Queensland, 호주, 4558
        • Pfizer Investigational Site
    • South Australia
      • Woodville, South Australia, 호주, 5011
        • Pfizer Investigational Site
    • Victoria
      • Malvern East, Victoria, 호주, 3145
        • Pfizer Investigational Site
    • Western Australia
      • Shenton Park, Western Australia, 호주, 6008
        • Pfizer Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
  • Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
  • Patient must remain on at least one background traditional disease modifying antirheumatic drug.
  • No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

Exclusion Criteria:

  • Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
  • History of any other rheumatic autoimmune disease other than Sjogren's syndrome.
  • No malignancy or history of malignancy.
  • History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 활성 10mg
의약품: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
의약품: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
실험적: Active 5 mg
의약품: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
의약품: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
위약 비교기: Placebo Sequence 1
Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.
의약품: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
위약 비교기: Placebo Sequence 2
Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
의약품: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
3개월째 건강 평가 설문지-장애 지수(HAQ-DI) 점수의 기준선에서 변경
기간: 기준, 3개월
HAQ-DI: 참가자가 보고한 일상 생활 활동의 8가지 범주에서 작업을 수행할 수 있는 능력 평가: 옷입기/몸단장;일어나기;먹기; 걷기; 도달; 그립; 위생, 지난 주 동안의 일반적인 활동. 각 항목은 0~3:0=어려움 없음, 1=약간 어려움, 2=매우 어려움, 3=할 수 없음의 4점 척도로 점수를 매겼습니다. 전체 점수는 도메인 점수의 합계로 계산하고 응답한 도메인 수로 나누었습니다. 총 가능한 점수 범위 0-3:0=가장 낮은 난이도 및 3=매우 어려움. CP-690,550과 위약을 비교하기 위해 위약 시퀀스를 3개월 분석을 위한 단일 보고 그룹으로 결합했습니다.
기준, 3개월
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
기간: Month 6
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Month 6
Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6
기간: Month 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Month 6

2차 결과 측정

결과 측정
측정값 설명
기간
9개월 및 12개월에 28-관절 수 및 C-반응성 단백질(3가지 변수)(DAS28-3[CRP])을 사용한 질병 활동 점수
기간: 9, 12월
DAS28-3(CRP)은 28개의 관절 수와 CRP(mg/L)를 사용하여 SJC와 TJC로부터 계산되었습니다. 총 점수 범위: 0 ~ 9.4, 점수가 높을수록 질병 활성도가 높음을 나타냅니다. DAS28-3(CRP) =<3.2는 낮은 질병 활성도를 암시하고, >3.2~5.1은 중등도 내지 높은 질병 활성도를 암시하고, <2.6은 완화를 암시했습니다.
9, 12월
9개월 및 12개월에 관절염 통증의 환자 평가
기간: 9, 12월
참가자들은 0~100mm VAS에서 관절염 통증의 중증도를 평가했습니다. 여기서 0mm는 통증 없음, 100mm는 가장 심한 통증입니다.
9, 12월
기준선, 3개월 및 6개월에서 RA-HCRU를 사용하여 평가된 방문, 수술, 테스트 또는 장치를 포함한 이벤트 수
기간: 기준, 3, 6개월
RA-HCRU는 지난 3개월 동안 직접 또는 간접 의료 비용 영역에 대한 의료 사용을 평가했습니다. 의사 방문, 비의료 개업의, 병원 ER 치료, 입원, 수술 횟수, 진단 테스트 및 사용된 장치/보조기를 포함하는 모든 RA/비 RA 관련 사건 수가 보고되었습니다.
기준, 3, 6개월
12개월차에 RA-HCRU를 사용하여 평가한 방문, 수술, 테스트 또는 장치를 포함한 이벤트 수
기간: 12월
RA-HCRU는 지난 3개월 동안 직접 또는 간접 의료 비용 영역에 대한 의료 사용을 평가했습니다. 의사 방문, 비의료 개업의, 병원 ER 치료, 입원, 수술 횟수, 진단 테스트 및 사용된 장치/보조기를 포함하는 모든 RA/비 RA 관련 사건 수가 보고되었습니다.
12월
기준선, 1, 3, 6개월차에 36항목 약식 건강 설문조사(SF-36)
기간: 기준, 월 1, 3, 6
SF-36은 기능적 건강과 웰빙의 8가지 측면을 평가하는 표준화된 설문조사입니다: 신체 기능, 신체 역할, 신체 통증, 일반 건강, 활력, 사회적 기능, 감정 및 정신 건강 역할. 섹션의 점수는 개별 질문 점수의 평균이며 0-100(100=가장 높은 수준의 기능)으로 표시되며 2개의 요약 점수로 보고됩니다. 신체 구성요소 점수 및 정신 구성요소 점수. 요약 점수의 총 점수 범위 = 0-100, 점수가 높을수록 기능 수준이 높음을 나타냅니다.
기준, 월 1, 3, 6
의학적 결과 연구 수면 척도(MOS-SS) 기준선, 1, 3, 6개월
기간: 기준, 월 1, 3, 6
지난 주 동안 수면 구성을 평가하기 위한 참가자 평가 12개 항목 설문지. 수면량(범위:0-24), 최적의 수면(예 또는 아니오). 수면 장애에 대한 9개 항목 지표 측정은 복합 점수를 제공합니다: 수면 문제 요약, 전반적인 수면 문제. 적절성, 최적, 수면량을 제외하고 점수가 높을수록 장애가 더 많습니다. 변환된 점수(실제 원점수(RS)에서 가능한 최저 점수를 가능한 RS 범위로 나눈 값*100); 총 점수 범위: 0-100, 높은 점수 = 더 높은 속성 강도.
기준, 월 1, 3, 6
기준선, 1, 3, 6개월에 의학적 결과 연구 수면 척도(MOS-SS)를 사용하여 최적의 수면을 평가한 참가자 수
기간: 기준, 월 1, 3, 6
MOS-SS: 지난 주 동안 수면 구성을 평가하기 위한 참가자 평가 12개 항목 설문지. 여기에는 수면 장애, 코골이, 호흡 곤란, 수면 적절성, 졸음, 수면량 및 최적 수면의 7개 하위 척도가 포함되었습니다. 참가자들은 예 또는 아니오를 선택하여 수면이 최적인지 여부에 응답했습니다. 최적의 수면을 취한 참가자의 수가 보고됩니다.
기준, 월 1, 3, 6
만성 질환 치료의 기능적 평가(FACIT) - 기준선, 1, 3, 6개월의 피로 척도
기간: 기준, 월 1, 3, 6
FACIT-Fatigue는 13개 항목으로 구성된 설문지입니다. 참가자는 5점 척도(0(전혀 아님)에서 4(매우 많이))로 각 항목에 점수를 매겼습니다. 질문에 대한 참가자의 응답이 클수록(부정적으로 언급된 2개 제외) 피로도가 커집니다. 2개의 부정적으로 언급된 질문을 제외한 모든 질문에 대해 코드가 바뀌었고 새로운 점수는 4에서 참가자의 응답을 뺀 값으로 계산되었습니다. 모든 응답의 합계는 0(더 나쁜 점수)에서 52(더 좋은 점수)의 총 가능한 점수에 대한 FACIT-Fatigue 점수로 귀결되었습니다. 점수가 높을수록 참가자의 건강 상태가 개선되었음을 반영합니다.
기준, 월 1, 3, 6
유로 삶의 질(EQ-5D) - 기준선, 3개월 및 6개월의 건강 상태 프로필 유틸리티 점수
기간: 기준, 3, 6개월
EQ-5D: 단일 효용 점수 측면에서 건강 관련 삶의 질을 평가하기 위한 참가자 평가 설문지. 건강 상태 프로필 구성 요소는 이동성, 자가 관리, 일상 활동, 통증 및 불편함, 불안 및 우울증의 5개 영역에 대한 현재 건강 수준을 평가합니다. 1은 더 나은 건강 상태를 나타냅니다(문제 없음). 3은 최악의 건강 상태를 나타냅니다("침상에 갇혀"). EuroQol Group에서 개발한 채점 공식은 프로필의 각 도메인에 대한 유틸리티 값을 할당합니다. 점수가 변환되어 총 점수 범위가 -0.594~1.000이 됩니다. 더 높은 점수는 더 나은 건강 상태를 나타냅니다.
기준, 3, 6개월
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
기간: Week 2, Month 1, 2, 3, 4.5, 6
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
기간: Month 9, 12
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
기간: Week 2, Month 1, 2, 3, 4.5, 6
ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
기간: Month 9, 12
ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
기간: Week 2, Month 1, 2, 3, 4.5, 6
ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12
기간: Month 9, 12
ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Month 9, 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
기간: Week 2, Month 1, 2, 3, 4.5, 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Week 2, Month 1, 2, 3, 4.5, 6
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6
기간: Baseline, Month 3, 6
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Baseline, Month 3, 6
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
기간: Month 12
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Month 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
기간: Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
기간: Baseline, Month 3, 6, 12
DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Baseline, Month 3, 6, 12
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
기간: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
기간: Month 9, Month 12
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Month 9, Month 12
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
기간: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
기간: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
기간: Month 9, 12
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Month 9, 12
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
기간: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Physician Global Assessment (PGA) of Arthritis at Month 9 and 12
기간: Month 9, 12
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Month 9, 12
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
기간: Month 9, 12
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Month 9, 12
Medical Outcome Study (MOS) Sleep Scale at Month 12
기간: Month 12
Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
Month 12
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
기간: Month 12
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Month 12
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
기간: Month 12
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Month 12
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12
기간: Month 12
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Month 12
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
기간: Baseline, Month 3, 6
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Baseline, Month 3, 6
Work Limitations Questionnaire (WLQ) Score at Month 12
기간: Month 12
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Month 12
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
기간: Baseline, Month 3, 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Baseline, Month 3, 6
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
기간: Month 12
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Month 12
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
기간: Baseline, Month 3, 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Baseline, Month 3, 6
Number of Days as Assessed Using RA-HCRU at Month 12
기간: Month 12
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Month 12
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
기간: Baseline, Month 3, 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Baseline, Month 3, 6
Number of Hours Per Day as Assessed RA-HCRU at Month 12
기간: Month 12
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Month 12
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
기간: Baseline, Month 3, 6
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Baseline, Month 3, 6
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
기간: Month 12
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Month 12

기타 결과 측정

결과 측정
측정값 설명
기간
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
기간: 2 weeks
Patient global assessment of arthritis: participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
2 weeks
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
기간: 2 weeks
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
2 weeks

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스폰서

Pfizer

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2012년 12월 1일

추가 정보

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추가 관련 MeSH 약관

기타 연구 ID 번호

  • A3921046

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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