Abatacept Versus Adalimumab Head-to-Head
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
1 other identifier
interventional
869
5 countries
83
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Oct 2009
Typical duration for phase_3 rheumatoid-arthritis
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
January 3, 2014
CompletedFebruary 4, 2014
January 1, 2014
2 years
June 29, 2009
November 14, 2013
January 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
Secondary Outcomes (6)
Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population
Day 1 to 12 Months
Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population
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
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
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
Day 1 to Day 729
- +1 more secondary outcomes
Study Arms (2)
Abatacept
ACTIVE COMPARATORAdalimumab
ACTIVE COMPARATORInterventions
Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Rheumatology Associates, Pc
Birmingham, Alabama, 35205, United States
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Clinical And Translational Research Center Of Alabama, Pc
Tuscaloosa, Alabama, 35406, United States
Sun Valley Arthritis Center, Ltd.
Peoria, Arizona, 85381, United States
Mercy Clinic Hot Springs Communities
Hot Springs, Arkansas, 71913, United States
Talbert Medical Group
Huntington Beach, California, 92646, United States
Allergy & Rheumatology Medical Clinic, Inc.
La Jolla, California, 92037, United States
Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
Long Beach, California, 90806, United States
Irene Y. Tong
Pasadena, California, 91107, United States
San Diego Arthritis Medical Clinic
San Diego, California, 92108, United States
Healthcare Partners Medical Group
Torrance, California, 90503, United States
Drs. Goldin, Nies, Klashman & Eng
Torrance, California, 90505, United States
Inland Rheumatology & Osteoporosis Medical Group
Upland, California, 91786, United States
Arthritis And Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
University Of Florida College Of Medicine At Jacksonville
Gainesville, Florida, 32610, United States
Center For Arthritis And Rheumatic Diseases
Miami, Florida, 33173, United States
Arthritis Research Of Florida, Inc.
Palm Harbor, Florida, 34684, United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239, United States
Miami Research Associates
South Miami, Florida, 33143, United States
West Broward Rheumatology Associates
Tamarac, Florida, 33321, United States
Lovelace Scientific Resources, Inc
Venice, Florida, 34292, United States
Arthritis & Rheumatology Of Georgia
Atlanta, Georgia, 30342, United States
Laureate Clinical Research Group
Atlanta, Georgia, 30342, United States
Arthritis Center Of North Georgia
Gainesville, Georgia, 30501, United States
St. Luke'S Clinic - Rheumatology
Boise, Idaho, 83702, United States
Coeur D'Alene Arthrit Clin
Coeur d'Alene, Idaho, 83814, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Rockford Orthopedic Associates, Ltd.
Rockford, Illinois, 61107, United States
Physicians Clinic Of Iowa
Cedar Rapids, Iowa, 52401, United States
Center For Arthritis And Osteoporosis
Elizabethtown, Kentucky, 42701, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, 40504, United States
Klein And Associates, M.D., Pa
Cumberland, Maryland, 21502, United States
The Center For Rheumatology And Bone Research
Wheaton, Maryland, 20902, United States
Brigham And Women'S Hospital
Boston, Massachusetts, 02115, United States
Mansfield Health Center
Mansfield, Massachusetts, 02048, United States
Associated Internal Medicine Specialists
Battle Creek, Michigan, 49015, United States
Rheumatology Pc
Kalamazoo, Michigan, 49009, United States
Arthritis Associates Of Mississippi
Jackson, Mississippi, 39202, United States
Physician Groups, Lc Dba
St Louis, Missouri, 63131, United States
Arthritis Center Of Reno
Reno, Nevada, 89502, United States
Seacoast Arthritis And Osteoporosis Center
Dover, New Hampshire, 03820, United States
Nashua Rheumatology
Nashua, New Hampshire, 03060, United States
Arthritis And Osteoporosis Associates Of New Mexico
Las Cruces, New Mexico, 88011, United States
North Shore Lij Health System
Lake Success, New York, 11042, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Rheumatology Associates Of Long Island
Smithtown, New York, 11787, United States
Asheville Rheumatology & Osteoporosis Research Asso P. A.
Asheville, North Carolina, 28803, United States
Carolina Pharmaceutical Research
Statesville, North Carolina, 28625, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Lynn Health Sciences Institute
Oklahoma City, Oklahoma, 73112, United States
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, 18015, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center Of Reading, Llp
Wyomissing, Pennsylvania, 19610, United States
Low Country Rheumatology, Pa
Charleston, South Carolina, 29406, United States
Columbia Arthritis Center, P.A.
Columbia, South Carolina, 29204, United States
Lovelace Scientific Resources, Inc.
Austin, Texas, 78758, United States
Arthritis Centers Of Texas
Dallas, Texas, 75246, United States
Rheumatic Disease Clinical Research Center, Llc
Houston, Texas, 77004, United States
Center For Arthritis & Rheumatic Diseases, Pc
Chesapeake, Virginia, 23320, United States
Rockwood Research Center
Spokane, Washington, 99202, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, United States
Rheumatic Disease Center
Glendale, Wisconsin, 53217, United States
Local Institution
Ciudad Autonoma de Beunos Aire, Buenos Aires, 1431, Argentina
Local Institution
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1015, Argentina
Local Institution
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1428DQG, Argentina
Local Institution
Ciudad Autonoma, Buenos Aires, CP1425A WC, Argentina
Local Institution
Quilmes, Buenos Aires, 1878, Argentina
Local Institution
Cordoba, Crd, Córdoba Province, X5016KEH, Argentina
Local Institution
Córdoba, Córdoba Province, 5000, Argentina
Local Institution
San Juan, San Juan Province, 5400, Argentina
Local Institution
Rosario, Santa Fe Province, 2000, Argentina
Local Institution
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Local Institution
Winnipeg, Manitoba, R3A 1M3, Canada
Local Institution
Hamilton, Ontario, L8N 1Y2, Canada
Local Institution
Québec, Quebec, G1V 3M7, Canada
Local Institution
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Local Institution
Santiago, Providencia, Chile
Local Institution
Bellavista, Callao 2, Peru
Local Institution
Lima, Lima Province, LIMA 11, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Lima, LIMA 27, Peru
Local Institution
Lima, LIMA 33, Peru
Related Publications (9)
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.
PMID: 34878629DERIVEDKeystone 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.
PMID: 31819995DERIVEDFleischmann 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.
PMID: 31642045DERIVEDFleischmann 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.
PMID: 27111089DERIVEDSchiff 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.
PMID: 27110385DERIVEDFleischmann 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.
PMID: 26473625DERIVEDSokolove 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.
PMID: 26359449DERIVEDSchiff 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.
PMID: 23962455DERIVEDWeinblatt 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.
PMID: 23169319DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2011
Study Completion
November 1, 2012
Last Updated
February 4, 2014
Results First Posted
January 3, 2014
Record last verified: 2014-01