Abatacept Versus Adalimumab Head-to-Head
2014년 1월 3일 업데이트: Bristol-Myers Squibb
A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive
연구 개요
연구 유형
중재적
등록 (실제)
869
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35294
- University of Alabama at Birmingham
-
Birmingham, Alabama, 미국, 35205
- Rheumatology Associates, Pc
-
Tuscaloosa, Alabama, 미국, 35406
- Clinical and Translational Research Center of Alabama, PC
-
-
Arizona
-
Peoria, Arizona, 미국, 85381
- Sun Valley Arthritis Center, Ltd.
-
-
Arkansas
-
Hot Springs, Arkansas, 미국, 71913
- Mercy Clinic Hot Springs Communities
-
-
California
-
Huntington Beach, California, 미국, 92646
- Talbert Medical Group
-
La Jolla, California, 미국, 92037
- Allergy & Rheumatology Medical Clinic, Inc.
-
Long Beach, California, 미국, 90806
- Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
-
Pasadena, California, 미국, 91107
- Irene Y. Tong
-
San Diego, California, 미국, 92108
- San Diego Arthritis Medical Clinic
-
Torrance, California, 미국, 90503
- Healthcare Partners Medical Group
-
Torrance, California, 미국, 90505
- Drs. Goldin, Nies, Klashman & Eng
-
Upland, California, 미국, 91786
- Inland Rheumatology & Osteoporosis Medical Group
-
-
Florida
-
Aventura, Florida, 미국, 33180
- Arthritis and Rheumatic Disease Specialties
-
Gainesville, Florida, 미국, 32610
- University Of Florida College Of Medicine At Jacksonville
-
Miami, Florida, 미국, 33173
- Center for Arthritis and Rheumatic Diseases
-
Palm Harbor, Florida, 미국, 34684
- Arthritis Research Of Florida, Inc.
-
Sarasota, Florida, 미국, 34239
- Sarasota Arthritis Research Center
-
South Miami, Florida, 미국, 33143
- Miami Research Associates
-
Tamarac, Florida, 미국, 33321
- West Broward Rheumatology Associates
-
Venice, Florida, 미국, 34292
- Lovelace Scientific Resources, Inc
-
-
Georgia
-
Atlanta, Georgia, 미국, 30342
- Arthritis & Rheumatology of Georgia
-
Atlanta, Georgia, 미국, 30342
- Laureate Clinical Research Group
-
Gainesville, Georgia, 미국, 30501
- Arthritis Center of North Georgia
-
-
Idaho
-
Boise, Idaho, 미국, 83702
- St. Luke's Clinic - Rheumatology
-
Coeur D Alene, Idaho, 미국, 83814
- Coeur D'Alene Arthrit Clin
-
-
Illinois
-
Quincy, Illinois, 미국, 62301
- Quincy Medical Group
-
Rockford, Illinois, 미국, 61107
- Rockford Orthopedic Associates, Ltd.
-
-
Iowa
-
Cedar Rapids, Iowa, 미국, 52401
- Physicians Clinic of Iowa
-
-
Kentucky
-
Elizabethtown, Kentucky, 미국, 42701
- Center For Arthritis and Osteoporosis
-
Lexington, Kentucky, 미국, 40504
- Bluegrass Community Research, Inc.
-
-
Maryland
-
Cumberland, Maryland, 미국, 21502
- Klein And Associates, M.D., Pa
-
Wheaton, Maryland, 미국, 20902
- The Center For Rheumatology And Bone Research
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
-
Mansfield, Massachusetts, 미국, 02048
- Mansfield Health Center
-
-
Michigan
-
Battle Creek, Michigan, 미국, 49015
- Associated Internal Medicine Specialists
-
Kalamazoo, Michigan, 미국, 49009
- Rheumatology Pc
-
-
Mississippi
-
Jackson, Mississippi, 미국, 39202
- Arthritis Associates Of Mississippi
-
-
Missouri
-
St.Louis, Missouri, 미국, 63131
- Physician Groups, Lc Dba
-
-
Nevada
-
Reno, Nevada, 미국, 89502
- Arthritis Center of Reno
-
-
New Hampshire
-
Dover, New Hampshire, 미국, 03820
- Seacoast Arthritis And Osteoporosis Center
-
Nashua, New Hampshire, 미국, 03060
- Nashua Rheumatology
-
-
New Mexico
-
Las Cruces, New Mexico, 미국, 88011
- Arthritis and Osteoporosis Associates of New Mexico
-
-
New York
-
Lake Success, New York, 미국, 11042
- North Shore Lij Health System
-
Mineola, New York, 미국, 11501
- Winthrop University Hospital
-
Smithtown, New York, 미국, 11787
- Rheumatology Associates of Long Island
-
-
North Carolina
-
Asheville, North Carolina, 미국, 28803
- Asheville Rheumatology & Osteoporosis Research Asso P. A.
-
Statesville, North Carolina, 미국, 28625
- Carolina Pharmaceutical Research
-
-
Oklahoma
-
Oklahoma City, Oklahoma, 미국, 73109
- Health Research Institute
-
Oklahoma City, Oklahoma, 미국, 73103
- Health Research of Oklahoma
-
Oklahoma City, Oklahoma, 미국, 73112
- Lynn Health Sciences Institute
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, 미국, 18015
- East Penn Rheumatology Associates, P.C.
-
Duncansville, Pennsylvania, 미국, 16635
- Altoona Center for Clinical Research
-
Wyomissing, Pennsylvania, 미국, 19610
- Clinical Research Center of Reading, LLP
-
-
South Carolina
-
Charleston, South Carolina, 미국, 29406
- Low Country Rheumatology, PA
-
Columbia, South Carolina, 미국, 29204
- Columbia Arthritis Center, P.A.
-
-
Texas
-
Austin, Texas, 미국, 78758
- Lovelace Scientific Resources, Inc.
-
Dallas, Texas, 미국, 75246
- Arthritis Centers Of Texas
-
Houston, Texas, 미국, 77004
- Rheumatic Disease Clinical Research Center, LLC
-
-
Virginia
-
Chesapeake, Virginia, 미국, 23320
- Center For Arthritis & Rheumatic Diseases, Pc
-
-
Washington
-
Spokane, Washington, 미국, 99202
- Rockwood Research Center
-
-
West Virginia
-
Clarksburg, West Virginia, 미국, 26301
- Mountain State Clinical Research
-
-
Wisconsin
-
Glendale, Wisconsin, 미국, 53217
- Rheumatic Disease Center
-
-
-
-
-
Cordoba, 아르헨티나, 5000
- Local Institution
-
San Juan, 아르헨티나, 5400
- Local Institution
-
Tucuman, 아르헨티나, 4000
- Local Institution
-
-
Buenos Aires
-
Ciudad Autonoma, Buenos Aires, 아르헨티나, CP1425A WC
- Local Institution
-
Ciudad Autonoma De Beunos Aire, Buenos Aires, 아르헨티나, 1431
- Local Institution
-
Ciudad Autonoma De Buenos Aire, Buenos Aires, 아르헨티나, 1015
- Local Institution
-
Ciudad Autonoma De Buenos Aire, Buenos Aires, 아르헨티나, C1428DQG
- Local Institution
-
Quilmes, Buenos Aires, 아르헨티나, 1878
- Local Institution
-
-
Cordoba
-
Cordoba, Crd, Cordoba, 아르헨티나, X5016KEH
- Local Institution
-
-
Santa Fe
-
Rosario, Santa Fe, 아르헨티나, 2000
- Local Institution
-
-
Tucuman
-
San Miguel De Tucuman, Tucuman, 아르헨티나, 4000
- Local Institution
-
-
-
-
Providencia
-
Santiago, Providencia, 칠레
- Local Institution
-
-
-
-
-
Quebec, 캐나다, G1V 3M7
- Local Institution
-
-
Manitoba
-
Winnipeg, Manitoba, 캐나다, R3A 1M3
- Local Institution
-
-
Ontario
-
Hamilton, Ontario, 캐나다, L8N 1Y2
- Local Institution
-
-
Quebec
-
Trois-Rivieres, Quebec, 캐나다, G8Z 1Y2
- Local Institution
-
-
-
-
-
Lima, 페루
- Local Institution
-
Lima, 페루, LIMA 11
- Local Institution
-
Lima, 페루, LIMA 33
- Local Institution
-
Lima, 페루, LIMA 27
- Local Institution
-
-
Callao 2
-
Bellavista, Callao 2, 페루
- 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:
- Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
- Methotrexate failure
- Naive to RA biologics
- ≤5 years duration of disease
- Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
- Willingness to self-inject subcutaneous (SC) drug
Exclusion Criteria:
- Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
- History of active or chronic hepatitis
- Cancer in the last 5 years
- History of severe chronic or recurrent bacterial or viral infections
- Risk of tuberculosis
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 아달리무맙
|
Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
다른 이름들:
|
|
활성 비교기: Abatacept
|
Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population
기간: Day 1 to Day 365
|
Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N).
The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage.
To qualify a ACR20 score, patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation).
Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale.
|
Day 1 to Day 365
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population
기간: Day 1 to 12 Months
|
n=number of participants with a pre-specified local injection site reaction event, N=number of participants at risk.
Proportion (%) = n/N.
12 Months includes data up to 56 days post last dose of the first 12 months Period or start of the first dose of second 12 months period.
|
Day 1 to 12 Months
|
|
Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population
기간: Day 1 to Day 729
|
Incidence Rate: (incidence/100 person-years) = number of participants with event * 100 /exposure (person-years) Exposure (person-years) = the sum over all participants of the exposure per participant in the 24 months (censored at the time of first occurrence of AE) expressed in days, divided by 365.25.
The 24 Month Period includes data up to 56 days post the last dose in the 24 month period.
Poisson distribution used to construct the 95% CIs.
|
Day 1 to Day 729
|
|
Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population
기간: Baseline to Day 729
|
Plain radiographs of hands and feet taken at baseline (BL), Day 365, and Day 729.
BL and Day 365 radiographs were re-read concurrent with Day 729 films by readers blinded to sequence and treatment (a second pre-specified reading campaign).
SDC defined as amount of change for which anything smaller could not be reliably distinguished from random error in measurement of simultaneously read films.
Non-progression defined: change from BL (Day 1, prior to dosing) in total score less than, equal to (<=) SDC(2.2).
Proportion n/m (%)=number meeting criteria (n); number analyzed (m).
SDC calculated as SD/sqrt(2)*1.96/sqrt(2)with
standard deviation (SD) of paired differences of change from BL in total score between 2 readers; squared root(sqrt).
mSvdHS=summary of erosion severity in 32 hand and 12 foot joints.
Hand joints scored 0 to 5; foot joints 0 to 10 with 0=no erosion and higher numbers indicating greater erosion severity.
BL: radiographic data within 14 days or less of first dose.
|
Baseline to Day 729
|
|
Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population
기간: Day 1 to Day 365
|
Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, all hospitalized infections.
Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post-last dose of first 12 months or start of first dose of second 12 months); denominator was overall total exposure (person-years) within this period, calculated as sum over all participants of exposure (in days) divided by 365.25.
The resulting incidence rate was multiplied by 100 to express rate per 100 person-years.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
|
Day 1 to Day 365
|
|
Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population
기간: Day 1 to Day 729
|
Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, and all hospitalized infections.
Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post the last dose of the 24 Months period); denominator was overall total exposure (person-years) within this period, which was calculated as the sum over all participants of exposure (in days) divided by 365.25.
The resulting incidence rate was multiplied by 100 to express the rate per 100 person-years.
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
|
Day 1 to Day 729
|
|
Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population
기간: Day 1 to Day 729
|
The induction of autoantibodies was defined as participant's antinuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) converting from a negative status at baseline to a positive status at a post-baseline measurement time point (Day 365 or Day 729).
Proportion (%) = n/m, where n=number of participants with positive ANA or dsDNA at a time point and m=number of participants who had negative ANA or dsDNA at baseline.
Blood samples were first tested for ANA by indirect fluorescent assay using HEp-2 Cell Line Substrate, and when positive, samples were further tested for anti-dsDNA by indirect fluorescent assay using Crithidia Luciliae Substrate.
|
Day 1 to Day 729
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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
- Keystone EC, Ahmad HA, Yazici Y, Bergman MJ. Disease activity measures at baseline predict structural damage progression: data from the randomized, controlled AMPLE and AVERT trials. Rheumatology (Oxford). 2020 Aug 1;59(8):2090-2098. doi: 10.1093/rheumatology/kez455.
- Jabado O, Maldonado MA, Schiff M, Weinblatt ME, Fleischmann R, Robinson WH, He A, Patel V, Greenfield A, Saini J, Galbraith D, Connolly SE. Differential Changes in ACPA Fine Specificity and Gene Expression in a Randomized Trial of Abatacept and Adalimumab in Rheumatoid Arthritis. Rheumatol Ther. 2022 Apr;9(2):391-409. doi: 10.1007/s40744-021-00404-x. Epub 2021 Dec 8.
- Fleischmann R, Weinblatt M, Ahmad H, Maldonado MA, Alemao E, Ye J, Schiff M. Efficacy of Abatacept and Adalimumab in Patients with Early Rheumatoid Arthritis With Multiple Poor Prognostic Factors: Post Hoc Analysis of a Randomized Controlled Clinical Trial (AMPLE). Rheumatol Ther. 2019 Dec;6(4):559-571. doi: 10.1007/s40744-019-00174-7. Epub 2019 Oct 22.
- Fleischmann R, Connolly SE, Maldonado MA, Schiff M. Brief Report: Estimating Disease Activity Using Multi-Biomarker Disease Activity Scores in Rheumatoid Arthritis Patients Treated With Abatacept or Adalimumab. Arthritis Rheumatol. 2016 Sep;68(9):2083-9. doi: 10.1002/art.39714.
- Schiff M, Weinblatt ME, Valente R, Citera G, Maldonado M, Massarotti E, Yazici Y, Fleischmann R. Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration. RMD Open. 2016 Apr 19;2(1):e000210. doi: 10.1136/rmdopen-2015-000210. eCollection 2016.
- Fleischmann R, Weinblatt ME, Schiff M, Khanna D, Maldonado MA, Nadkarni A, Furst DE. Patient-Reported Outcomes From a Two-Year Head-to-Head Comparison of Subcutaneous Abatacept and Adalimumab for Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016 Jul;68(7):907-13. doi: 10.1002/acr.22763.
- Sokolove J, Schiff M, Fleischmann R, Weinblatt ME, Connolly SE, Johnsen A, Zhu J, Maldonado MA, Patel S, Robinson WH. Impact of baseline anti-cyclic citrullinated peptide-2 antibody concentration on efficacy outcomes following treatment with subcutaneous abatacept or adalimumab: 2-year results from the AMPLE trial. Ann Rheum Dis. 2016 Apr;75(4):709-14. doi: 10.1136/annrheumdis-2015-207942. Epub 2015 Sep 10.
- Schiff M, Weinblatt ME, Valente R, van der Heijde D, Citera G, Elegbe A, Maldonado M, Fleischmann R. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014 Jan;73(1):86-94. doi: 10.1136/annrheumdis-2013-203843. Epub 2013 Aug 20.
- Weinblatt ME, Schiff M, Valente R, van der Heijde D, Citera G, Zhao C, Maldonado M, Fleischmann R. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013 Jan;65(1):28-38. doi: 10.1002/art.37711.
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
2009년 10월 1일
기본 완료 (실제)
2011년 10월 1일
연구 완료 (실제)
2012년 11월 1일
연구 등록 날짜
최초 제출
2009년 6월 29일
QC 기준을 충족하는 최초 제출
2009년 6월 29일
처음 게시됨 (추정)
2009년 6월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 2월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 1월 3일
마지막으로 확인됨
2014년 1월 1일
추가 정보
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. .