이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Remission and Joint Damage Progression in Early Rheumatoid Arthritis

2010년 11월 3일 업데이트: Bristol-Myers Squibb

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

1052

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 남아프리카
    • Free State
      • Bloemfontein, Free State, 남아프리카, 9317
        • Local Institution
    • Gauteng
      • Muckleneuk, Gauteng, 남아프리카, 0002
        • Local Institution
      • Pretoria, Gauteng, 남아프리카, 0084
        • Local Institution
    • Kwa Zulu Natal
      • Berea, Kwa Zulu Natal, 남아프리카, 4001
        • Local Institution
    • Western Cape
      • Panorama, Western Cape, 남아프리카, 7506
        • Local Institution
  • 네덜란드
      • Amsterdam, 네덜란드, 1081 HV
        • Local Institution
      • Leiden, 네덜란드, 2300 RC
        • Local Institution
      • Nijmegen, 네덜란드, 6500 HB
        • Local Institution
  • 대한민국
      • Anyang, 대한민국, 431-070
        • Local Institution
      • Daegu, 대한민국, 705-718
        • Local Institution
      • Daejeon, 대한민국, 302-799
        • Local Institution
      • Seoul, 대한민국, 110-744
        • Local Institution
      • Seoul, 대한민국, 137-040
        • Local Institution
      • Seoul, 대한민국, 138-736
        • Local Institution
      • Seoul, 대한민국, 133-792
        • Local Institution
  • 독일
      • Berlin, 독일, 14059
        • Local Institution
      • Hamburg, 독일, 22081
        • Local Institution
      • Leipzig, 독일, 04103
        • Local Institution
      • Leipzig, 독일, 04229
        • Local Institution
  • 러시아 연방
      • Moscow, 러시아 연방, 115522
        • Local Institution
      • Moscow, 러시아 연방, 119049
        • Local Institution
  • 멕시코
      • Chihuahua, 멕시코, 31000
        • Local Institution
      • San Luis Potosi, 멕시코, 78240
        • Local Institution
    • Distrito Federal
      • D.f., Distrito Federal, 멕시코, 06700
        • Local Institution
    • Estado De Mexico
      • Metepec, Estado De Mexico, 멕시코, 52140
        • Local Institution
    • Guanajuato
      • Leon, Guanajuato, 멕시코, 37000
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, 멕시코, 44340
        • Local Institution
      • Guadalajara, Jalisco, 멕시코, 44690
        • Local Institution
      • Guadalajara, Jalisco, 멕시코, 42650
        • Local Institution
    • Michioacan
      • Morelia, Michioacan, 멕시코, 58000
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, 멕시코, 62270
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, 멕시코, 64020
        • Local Institution
  • 미국
    • Alabama
      • Huntsville, Alabama, 미국, 35801
        • Rheumatology Associates of North Alabama
    • California
      • Huntington Beach, California, 미국, 92646
        • Talbert Medical Group
    • Colorado
      • Colorado Springs, Colorado, 미국, 80910
        • Arthritis Assoc And Osteo Ctr Of Col Sprgs
    • Connecticut
      • Trumbull, Connecticut, 미국, 06611
        • New England Research Associates, LLC
    • Indiana
      • Indianapolis, Indiana, 미국, 46227
        • Diagnostic Rheumatology and Research
    • Maryland
      • Cumberland, Maryland, 미국, 21502
        • Osteoporosis and Clinical Trials Center
      • Hagerstown, Maryland, 미국, 21740
        • Malamet & Klein, MD, PA
    • Nebraska
      • Lincoln, Nebraska, 미국, 68516
        • Arthritis Center of Nebraska
    • New York
      • Binghamton, New York, 미국, 13905
        • Regional Rheumatology Associates
    • North Carolina
      • Charlotte, North Carolina, 미국, 28210
        • Carolina Bone & Joint
      • Greenville, North Carolina, 미국, 27834
        • Physicians East, PA
      • Statesville, North Carolina, 미국, 28625
        • Carolina Pharmaceutical Research
    • Oklahoma
      • Norman, Oklahoma, 미국, 73071
        • Lion Research
      • Oklahoma City, Oklahoma, 미국, 73103
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73112
        • Lynn Health Sciences Institute
    • Pennsylvania
      • Duncansville, Pennsylvania, 미국, 16635
        • Altoona Center for Clinical Research
    • South Carolina
      • Charleston, South Carolina, 미국, 29406
        • Low Country Research Center
    • Texas
      • Austin, Texas, 미국, 78705
        • Walter F Chase Md Pa
    • Virginia
      • Arlington, Virginia, 미국, 22205
        • Arthritis Clinic Of Northern Virginia, P.C.
  • 벨기에
      • Antwerpen, 벨기에, 2020
        • Local Institution
      • Bruxelles, 벨기에, 1200
        • Local Institution
      • Bruxelles, 벨기에, 1070
        • Local Institution
      • Hasselt, 벨기에, 3500
        • Local Institution
      • Leuven, 벨기에, 3000
        • Local Institution
  • 브라질
      • Sao Paulo, 브라질, 04039
        • Local Institution
      • Sao Paulo, 브라질, 04230
        • Local Institution
    • Goias
      • Goiania, Goias, 브라질, 74043
        • Local Institution
    • Parana
      • Curitiba, Parana, 브라질, 80060
        • Local Institution
    • Rio De Janeiro
      • Rio De Janeiro - Rj, Rio De Janeiro, 브라질, 20551
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, 브라질, 91610
        • Local Institution
  • 스페인
      • A Coruna, 스페인, 15706
        • Local Institution
      • Santander, 스페인, 39008
        • Local Institution
      • Sevilla, 스페인, 41071
        • Local Institution
  • 영국
    • Greater Manchester
      • Manchester, Greater Manchester, 영국, M13 9WL
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, 영국, G12 0YN
        • Local Institution
    • North Yorkshire
      • Leeds, North Yorkshire, 영국, LS7 4SA
        • Local Institution
    • Northumberland
      • Newcastle, Northumberland, 영국, NE1 4LP
        • Local Institution
  • 이탈리아
      • Jesi(Ancona), 이탈리아, 60055
        • Local Institution
      • Milano, 이탈리아, 20157
        • Local Institution
  • 체코 공화국
      • Prague 2, 체코 공화국, 128 50
        • Local Institution
  • 캐나다
      • Quebec, 캐나다, G1V 3M7
        • Local Institution
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, 캐나다, A1B 3E1
        • Local Institution
    • Ontario
      • Kitchener, Ontario, 캐나다, N2M 5N6
        • Local Institution
      • Toronto, Ontario, 캐나다, M5G 1X5
        • Local Institution
    • Quebec
      • Montreal, Quebec, 캐나다, H2L 1S6
        • Local Institution
      • Sherbrooke, Quebec, 캐나다, J1H 5N4
        • Local Institution
    • Saskatchewan
      • Saskatoon, Saskatchewan, 캐나다, S7N 0W8
        • Local Institution
  • 폴란드
      • Poznan, 폴란드, 60773
        • Local Institution
      • Poznan, 폴란드, 61-545
        • Local Institution
      • Warszawa, 폴란드, 02-637
        • Local Institution
  • 푸에르토 리코
      • Ponce, 푸에르토 리코, 00716
        • Local Institution
  • 프랑스
      • Dijon, 프랑스, 21000
        • Local Institution
      • Montpellier Cedex 5, 프랑스, 34295
        • Local Institution
      • Nice Cedex 03, 프랑스, 06202
        • Local Institution
      • Strasbourg Cedex, 프랑스, 67098
        • Local Institution
  • 호주
    • Victoria
      • Malvern, Victoria, 호주, 3144
        • Local Institution
    • Western Australia
      • Shenton Park, Western Australia, 호주, 6008
        • Local Institution

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:

  • Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3 weeks. No dose within 3 months prior to informed consent.
  • C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)
  • Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
  • Tender joints >=12 and swollen joints >=10

Exclusion Criteria:

  • Women and men who are not willing to use birth control
  • Diagnosed with other rheumatic disease
  • History of cancer within 5 years
  • Active tuberculosis
  • Treatment with another investigation drug within 28 days
  • Active bacterial or viral infection

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: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: ABA + MTX
abatacept 10 mg/kg intravenous (IV) + methotrexate
의약품: Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
의약품: methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
활성 비교기: Placebo (PLA) + MTX
placebo IV + methotrexate
의약품: Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
의약품: methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
의약품: placebo
placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants in DAS 28 C-reactive Protein (CRP) Remission at Month 12
기간: Month 12
Number of participants who achieved remission at Month 12 of treatment, as defined by a Disease Activity Score (DAS) 28-CRP score of <2.6. DAS 28-CRP is a continuous measure, a composite of 4 variables: number of tender joints out of 28 joints, number of swollen joints out of 28 joints, CRP (in mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 (best) to 10 (worst), indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1 = high disease activity; <=3.2 = low disease activity; <2.6 = remission.
Month 12
Mean Change From Baseline in Radiographic Total Score to Month 12
기간: Baseline, Month 12
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.
Baseline, Month 12
Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs During the Open-Label Period
기간: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of Participants With Serious Adverse Events Reported During the Open-Label Period
기간: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of Participants With SAEs With an Outcome of Death During the Open-label Period
기간: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Any untoward medical occurrence (SAE) that resulted in death
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Incidence Rates of Autoimmune Disorders in ABA-Treated Participants
기간: Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).
The incidence rates of autoimmune disorders are defined as the (number of patients experiencing the event/exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.
Double Blind Period (+56 days post last dose in double-blind period or start of open-label period, whichever came first). Open-label period (56 days post last dose in the open-label period or start of maintenance sub-study, whichever came first).
Incidence Rates of Infections and Infestations of Adverse Events in ABA-Treated Participants
기간: Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
The incidence rates of infections and infestations are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.
Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
Incidence Rates of Malignant Neoplasm Adverse Events in ABA-Treated Participants
기간: Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
The incidence rates of malignant neoplasms are defined as the (number of patients experiencing the event /exposure within the period)*100 and are expressed in 100 person-years. Subjects experiencing the event had their exposure censored at the time of the 1st event.
Double Blind Period (+56 days post last dose in double-blind period or start of the open-label period, whichever came first). Open-label period (56 days post last dose in open-label period or start of maintenance sub-study, whichever came first).
Number of Participants With a Serious Acute-Infusional AE of Anaphylactic Shock During Open-Label Period
기간: Open-Label Period (Month 12 to Month 24)
There were 107 Prespecified, acute-infusional SAEs (occurring within 1 hour after the start of study drug infusion) pre-specified in the protocol; anaphylactic shock was the only one occuring in this study.
Open-Label Period (Month 12 to Month 24)
Number of Participants With Select Blood Chemistry Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period
기간: Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of subjects with high liver function and kinedy tests: alkaline phosphatase (ALP) >2x upper limit of normal (ULN) or if pretreatment (PRE-RX) >ULN then >3x PRE-RX; aspartate aminotransferase (AST) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; alanine aminotransferase (ALT) >3x ULN or if PRE-RX >ULN then >4x PRE-RX; g-glutamyl transferase (GGT)>2x ULN or if PRE-RX >ULN then >3x PRE-RX; total bilirubin >2x ULN or if PRE-RX >ULN then >4x PRE-RX; blood urea nitrogen >2x PRE-RX; creatinine >1.5x PRE-RX.
Continuously through open-label period (from Month 12 to Month 24). Includes data up to 56 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of Participants With Hematology Laboratory Values Meeting the Marked Abnormality Criteria During the Open-Label Period
기간: Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Marked abnormalities in hemoglobin >3 g/dL decrease from PRE-RX; hematocrit <0.75x PRE-RX; erythrocytes <0.75x PRE-RX; platelet count <0.67x lower limit of normal (LLN) or >1.5x ULN or if PRE-RX <LLN then <0.5x PRE-RX and <100,000/mm3; leukocytes <0.75x LLN or >1.25x ULN or if PRE-RX <LLN then <0.8x PRE-RX or >ULN if PRE-RX >ULN then >1.2x PRE-RX or <LLN; neutrophils if value <1.00 x10^3 c/uL; lymphocytes if value <.750 x10^3 c/uL or if value >7.50 x10^3 c/uL; monocytes if value >2000/MM3; basophils if value >400/mm3; eosinophils if value >.750 x10^3 c/uL
Continuously from start of open-label period up to 56 days post the last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With American College of Rheumatology (ACR) 50 Response at Month 12
기간: Month 12
ACR 50 response was defined as a 50% improvement from baseline to Month 12 in tender and swollen joint counts and 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function), and 1 acute phase reactant value [ie, CRP].
Month 12
Number of Participants With Major Clinical Response (MCR) at Month 12
기간: Month 12
MCR was defined as 6 months of consecutive ACR 70 response at Month 12. ACR 70, the American College of Rheumatology (ACR) definition of 70% improvement was based on a 70% improvement (compared to baseline values) in tender and swollen joint counts and 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function, and 1 acute phase reactant value [ie, CRP]).
Month 12
Adjusted Mean Change From Baseline in DAS-28-CRP Score to Month 12
기간: Baseline, Month 12
DAS 28-CRP is a continuous variable that is a composite of 4 variables: the number of tender joints out of 28 joints, the number of swollen joints out of 28 joints, CRP in milligrams/Liter (mg/L), and subject assessment of disease activity measure on a Visual Analogue Scale (VAS) of 100 millimeters (mm). The DAS28 scale=0 to 10, indicating the current activity of the rheumatoid arthritis. A DAS28 >5.1=high disease activity; <3.2=low disease activity; <2.6=remission. Change from Baseline=Post-baseline - Baseline value; Adjusted for baseline value.
Baseline, Month 12
Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 12
기간: Month 12
Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.
Month 12
Adjusted Mean Change in Short Form 36 (SF-36) From Baseline to Month 12
기간: Baseline, Month 12
The SF-36 covers 8 health dimensions: 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from 0 to 100, with a higher score indicating better quality of life. Two summary scores (physical and mental component summaries) were produced taking a weighted linear combination of the 8 individual subscales. Change from Baseline=Post-baseline - Baseline value; adjusted for baseline value.
Baseline, Month 12
Mean Change From Baseline in Radiographic Erosion and Joint Space Narrowing (JSN) Scores to Month 12
기간: Baseline, Month 12
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). The joint space narrowing score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value
Baseline, Month 12
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses in the Double-blind Period as Analyzed by Enzyme-linked-immunosorbent Serologic Assay (ELISA)
기간: includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.
Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).
includes data up to approximately 85 days past the last dose of the double-blind period or start of the open-label period, whichever occurred first.
Number of Participants With Anti-abatacept or Anti-CTLA4-T Responses During the Open-Label Period (From Month 12 to Month 24) as Analyzed by ELISA
기간: Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Serum samples were analyzed by ELISA to detect antibodies against the whole molecule (both CTLA4 and Ig [anti-abatacept antibody]) or solely to CTLA4 (anti-CTLA4-T antibody). Reported as titer, the reciprocal of the sample dilution which yielded a signal equivalent to the statistically set cut point for the assay. For the anti-abatacept assay, minimum required dilution is 400-fold, therefore seronegative samples are those < lowest reportable titer (<400). For the anti-CTLA4-T assay, minimum required dilution is 25-fold, therefore seronegative samples are those < lowest reportable titer (<25).
Includes open-label data up to approximately 85 days post last dose in the open-label period or start of the maintenance sub-study, whichever occurred first.
Number of Participants With Health Assessment Questionnaire (HAQ) Response at Month 24
기간: Baseline, Month 24
Physical function was evaluated using the HAQ-disability index (HAQ-DI), a questionnaire with 20 questions assessing function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The 8 category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). Higher scores indicate greater dysfunction. HAQ response=improvement of at least 0.3 units from baseline.
Baseline, Month 24
Mean Change From Baseline in Radiographic Total, Erosion and JSN Scores to Month 24
기간: Baseline, Month 24
To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Postbaseline - baseline value.
Baseline, Month 24
Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) From Baseline at Month 24
기간: Baseline, Month 24
Participants with no radiographic progression (defined as change in score <=0 or <=0.5), from baseline to Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.
Baseline, Month 24
Number of Participants Without Radiographic Progression (as Measured by in Erosion Scores, JSN Scores, and Total Scores) at Month 24 in Participants Without Progression at Month 12
기간: Month 12, Month 24
Participants with no radiographic progression ((defined as change in score <=0 or <=0.5), sustained from Month 12 and Month 24. To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.
Month 12, Month 24
Mean Difference Observed in Change From Baseline to Month 12 and Between Month 12 and Month 24 in Radiographic Scores (Total Score)
기간: Baseline, Month 12, Month 24
Mean difference observed in change from baseline to Month 12 and between Month 12 and Month 24 in radiographic scores (Total Score). To assess joint damage, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and JSN. The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage.
Baseline, Month 12, Month 24
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Reported During the Double-blind Period
기간: Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. Related AE/SAE=Certain, Probable, Possible, or Missing. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.
Number of Participants With Laboratory Values Meeting the Marked Abnormality Criteria During the Double-blind Period
기간: Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.
Number of participants with laboratory values (hematology, liver and kidney functions, electrolytes, glucose tests, protein tests, metabolite tests, and urine chemistry tests) considered markedly abnormal according to prespecified protocol criteria
Includes data up to 56 days post the last dose in the double-blind period or start of the open-label period, whichever occurred first.

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Bristol-Myers Squibb

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2005년 7월 1일

기본 완료 (실제)

2008년 2월 1일

연구 완료 (실제)

2009년 2월 1일

연구 등록 날짜

최초 제출

2005년 7월 19일

QC 기준을 충족하는 최초 제출

2005년 7월 19일

처음 게시됨 (추정)

2005년 7월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2010년 11월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2010년 11월 3일

마지막으로 확인됨

2010년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IM101-023

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Abatacept에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Malawi

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약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다