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Rheumatoid ArthritisPhase 3NCT00929864

Abatacept Versus Adalimumab Head-to-Head

A Phase 3 study testing Abatacept and Adalimumab in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 83 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Abatacept and Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
869 participants
Where
83 sitesin 5 countries
Study dates
Oct 2009to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

83 sites in 5 countries.

83 sites in 5 countries

United States63 sites

  • Asheville Rheumatology & Osteoporosis Research Asso P. A.

    Asheville, North Carolina, 28803

  • Arthritis & Rheumatology Of Georgia

    Atlanta, Georgia, 30342

  • Laureate Clinical Research Group

    Atlanta, Georgia, 30342

  • Lovelace Scientific Resources, Inc.

    Austin, Texas, 78758

  • Arthritis And Rheumatic Disease Specialties

    Aventura, Florida, 33180

  • Associated Internal Medicine Specialists

    Battle Creek, Michigan, 49015

  • East Penn Rheumatology Associates, P.C.

    Bethlehem, Pennsylvania, 18015

  • Rheumatology Associates, Pc

    Birmingham, Alabama, 35205

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35294

  • St. Luke'S Clinic - Rheumatology

    Boise, Idaho, 83702

  • Brigham And Women'S Hospital

    Boston, Massachusetts, 02115

  • Physicians Clinic Of Iowa

    Cedar Rapids, Iowa, 52401

  • Low Country Rheumatology, Pa

    Charleston, South Carolina, 29406

  • Center For Arthritis & Rheumatic Diseases, Pc

    Chesapeake, Virginia, 23320

  • Mountain State Clinical Research

    Clarksburg, West Virginia, 26301

  • Coeur D'Alene Arthrit Clin

    Coeur d'Alene, Idaho, 83814

  • Columbia Arthritis Center, P.A.

    Columbia, South Carolina, 29204

  • Klein And Associates, M.D., Pa

    Cumberland, Maryland, 21502

  • Arthritis Centers Of Texas

    Dallas, Texas, 75246

  • Seacoast Arthritis And Osteoporosis Center

    Dover, New Hampshire, 03820

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Center For Arthritis And Osteoporosis

    Elizabethtown, Kentucky, 42701

  • University Of Florida College Of Medicine At Jacksonville

    Gainesville, Florida, 32610

  • Arthritis Center Of North Georgia

    Gainesville, Georgia, 30501

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Mercy Clinic Hot Springs Communities

    Hot Springs, Arkansas, 71913

  • Rheumatic Disease Clinical Research Center, Llc

    Houston, Texas, 77004

  • Talbert Medical Group

    Huntington Beach, California, 92646

  • Arthritis Associates Of Mississippi

    Jackson, Mississippi, 39202

  • Rheumatology Pc

    Kalamazoo, Michigan, 49009

  • Allergy & Rheumatology Medical Clinic, Inc.

    La Jolla, California, 92037

  • North Shore Lij Health System

    Lake Success, New York, 11042

  • Arthritis And Osteoporosis Associates Of New Mexico

    Las Cruces, New Mexico, 88011

  • Bluegrass Community Research, Inc.

    Lexington, Kentucky, 40504

  • Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

    Long Beach, California, 90806

  • Mansfield Health Center

    Mansfield, Massachusetts, 02048

  • Center For Arthritis And Rheumatic Diseases

    Miami, Florida, 33173

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Nashua Rheumatology

    Nashua, New Hampshire, 03060

  • Health Research Of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Health Research Institute

    Oklahoma City, Oklahoma, 73109

  • Lynn Health Sciences Institute

    Oklahoma City, Oklahoma, 73112

  • Arthritis Research Of Florida, Inc.

    Palm Harbor, Florida, 34684

  • Irene Y. Tong

    Pasadena, California, 91107

  • Sun Valley Arthritis Center, Ltd.

    Peoria, Arizona, 85381

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Arthritis Center Of Reno

    Reno, Nevada, 89502

  • Rockford Orthopedic Associates, Ltd.

    Rockford, Illinois, 61107

  • San Diego Arthritis Medical Clinic

    San Diego, California, 92108

  • Sarasota Arthritis Research Center

    Sarasota, Florida, 34239

  • Rheumatology Associates Of Long Island

    Smithtown, New York, 11787

  • Miami Research Associates

    South Miami, Florida, 33143

  • Rockwood Research Center

    Spokane, Washington, 99202

  • Physician Groups, Lc Dba

    St Louis, Missouri, 63131

  • Carolina Pharmaceutical Research

    Statesville, North Carolina, 28625

  • West Broward Rheumatology Associates

    Tamarac, Florida, 33321

  • Healthcare Partners Medical Group

    Torrance, California, 90503

  • Drs. Goldin, Nies, Klashman & Eng

    Torrance, California, 90505

  • Clinical And Translational Research Center Of Alabama, Pc

    Tuscaloosa, Alabama, 35406

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California, 91786

  • Lovelace Scientific Resources, Inc

    Venice, Florida, 34292

  • The Center For Rheumatology And Bone Research

    Wheaton, Maryland, 20902

  • Clinical Research Center Of Reading, Llp

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Argentina10 sites

  • Local Institution

    Ciudad Autonoma, Buenos Aires, CP1425A WC

  • Local Institution

    Ciudad Autonoma de Beunos Aire, Buenos Aires, 1431

  • Local Institution

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1015

  • Local Institution

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1428DQG

  • Local Institution

    Córdoba, Córdoba Province, 5000

  • Local Institution

    Cordoba, Crd, Córdoba Province, X5016KEH

  • Local Institution

    Quilmes, Buenos Aires, 1878

  • Local Institution

    Rosario, Santa Fe Province, 2000

  • Local Institution

    San Juan, San Juan Province, 5400

  • Local Institution

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Peru5 sites

  • Local Institution

    Bellavista, Callao 2

  • Local Institution

    Lima, Lima Province, LIMA 11

  • Local Institution

    Lima, Lima Province

  • Local Institution

    Lima, LIMA 27

  • Local Institution

    Lima, LIMA 33

Other trials in Peru

Canada4 sites

  • Local Institution

    Hamilton, Ontario, L8N 1Y2

  • Local Institution

    Québec, Quebec, G1V 3M7

  • Local Institution

    Trois-Rivières, Quebec, G8Z 1Y2

  • Local Institution

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Chile1 site

  • Local Institution

    Santiago, Providencia

Other trials in Chile

About this study

Official title: 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

Being tested
Abatacept, Adalimumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbataceptDrug

    Also called Orencia, BMS-188667

    Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)

  • AdalimumabDrug

    Also called Humira

    Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)

Study groups in NCT00929864
Study groupRoleWhat they receive
AbataceptActive comparatorNot described
Receives: Drug: Abatacept
AdalimumabActive comparatorNot described
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 to Day 365

Secondary outcomes (6)

  1. Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population

    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.

    Measured: Day 1 to 12 Months

  2. Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population

    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.

    Measured: Day 1 to Day 729

  3. 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

    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.

    Measured: Baseline to Day 729

  4. 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

    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.

    Measured: Day 1 to Day 365

  5. 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

    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.

    Measured: Day 1 to Day 729

  6. Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population

    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.

    Measured: Day 1 to Day 729

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionOct 2011
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
869 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00929864
Sponsor's protocol ID
IM101-235
Status last verified
Jan 2014
First submitted
29 Jun 2009
Last updated
4 Feb 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 34878629

  • 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.

    PubMed 31819995

  • 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.

    PubMed 31642045

  • 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.

    PubMed 27111089

  • 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.

    PubMed 27110385

  • 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.

    PubMed 26473625

  • 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.

    PubMed 26359449

  • 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.

    PubMed 23962455

  • 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.

    PubMed 23169319

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abatacept and Adalimumab in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 83 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Argentina, Peru, Canada, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 1 to Day 365). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00929864, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014; AzTrials last refreshed its copy on 2 Nov 2026.

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