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Abatacept Versus Adalimumab Head-to-Head

3 januari 2014 bijgewerkt door: 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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

869

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Cordoba, Argentinië, 5000
        • Local Institution
      • San Juan, Argentinië, 5400
        • Local Institution
      • Tucuman, Argentinië, 4000
        • Local Institution
    • Buenos Aires
      • Ciudad Autonoma, Buenos Aires, Argentinië, CP1425A WC
        • Local Institution
      • Ciudad Autonoma De Beunos Aire, Buenos Aires, Argentinië, 1431
        • Local Institution
      • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentinië, 1015
        • Local Institution
      • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentinië, C1428DQG
        • Local Institution
      • Quilmes, Buenos Aires, Argentinië, 1878
        • Local Institution
    • Cordoba
      • Cordoba, Crd, Cordoba, Argentinië, X5016KEH
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentinië, 2000
        • Local Institution
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentinië, 4000
        • Local Institution
  • Canada
      • Quebec, Canada, G1V 3M7
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1Y2
        • Local Institution
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Local Institution
  • Chili
    • Providencia
      • Santiago, Providencia, Chili
        • Local Institution
  • Peru
      • Lima, Peru
        • Local Institution
      • Lima, Peru, LIMA 11
        • Local Institution
      • Lima, Peru, LIMA 33
        • Local Institution
      • Lima, Peru, LIMA 27
        • Local Institution
    • Callao 2
      • Bellavista, Callao 2, Peru
        • Local Institution
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Verenigde Staten, 35205
        • Rheumatology Associates, Pc
      • Tuscaloosa, Alabama, Verenigde Staten, 35406
        • Clinical and Translational Research Center of Alabama, PC
    • Arizona
      • Peoria, Arizona, Verenigde Staten, 85381
        • Sun Valley Arthritis Center, Ltd.
    • Arkansas
      • Hot Springs, Arkansas, Verenigde Staten, 71913
        • Mercy Clinic Hot Springs Communities
    • California
      • Huntington Beach, California, Verenigde Staten, 92646
        • Talbert Medical Group
      • La Jolla, California, Verenigde Staten, 92037
        • Allergy & Rheumatology Medical Clinic, Inc.
      • Long Beach, California, Verenigde Staten, 90806
        • Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
      • Pasadena, California, Verenigde Staten, 91107
        • Irene Y. Tong
      • San Diego, California, Verenigde Staten, 92108
        • San Diego Arthritis Medical Clinic
      • Torrance, California, Verenigde Staten, 90503
        • Healthcare Partners Medical Group
      • Torrance, California, Verenigde Staten, 90505
        • Drs. Goldin, Nies, Klashman & Eng
      • Upland, California, Verenigde Staten, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
    • Florida
      • Aventura, Florida, Verenigde Staten, 33180
        • Arthritis and Rheumatic Disease Specialties
      • Gainesville, Florida, Verenigde Staten, 32610
        • University Of Florida College Of Medicine At Jacksonville
      • Miami, Florida, Verenigde Staten, 33173
        • Center for Arthritis and Rheumatic Diseases
      • Palm Harbor, Florida, Verenigde Staten, 34684
        • Arthritis Research Of Florida, Inc.
      • Sarasota, Florida, Verenigde Staten, 34239
        • Sarasota Arthritis Research Center
      • South Miami, Florida, Verenigde Staten, 33143
        • Miami Research Associates
      • Tamarac, Florida, Verenigde Staten, 33321
        • West Broward Rheumatology Associates
      • Venice, Florida, Verenigde Staten, 34292
        • Lovelace Scientific Resources, Inc
    • Georgia
      • Atlanta, Georgia, Verenigde Staten, 30342
        • Arthritis & Rheumatology of Georgia
      • Atlanta, Georgia, Verenigde Staten, 30342
        • Laureate Clinical Research Group
      • Gainesville, Georgia, Verenigde Staten, 30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise, Idaho, Verenigde Staten, 83702
        • St. Luke's Clinic - Rheumatology
      • Coeur D Alene, Idaho, Verenigde Staten, 83814
        • Coeur D'Alene Arthrit Clin
    • Illinois
      • Quincy, Illinois, Verenigde Staten, 62301
        • Quincy Medical Group
      • Rockford, Illinois, Verenigde Staten, 61107
        • Rockford Orthopedic Associates, Ltd.
    • Iowa
      • Cedar Rapids, Iowa, Verenigde Staten, 52401
        • Physicians Clinic of Iowa
    • Kentucky
      • Elizabethtown, Kentucky, Verenigde Staten, 42701
        • Center For Arthritis and Osteoporosis
      • Lexington, Kentucky, Verenigde Staten, 40504
        • Bluegrass Community Research, Inc.
    • Maryland
      • Cumberland, Maryland, Verenigde Staten, 21502
        • Klein And Associates, M.D., Pa
      • Wheaton, Maryland, Verenigde Staten, 20902
        • The Center For Rheumatology And Bone Research
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Brigham and Women's Hospital
      • Mansfield, Massachusetts, Verenigde Staten, 02048
        • Mansfield Health Center
    • Michigan
      • Battle Creek, Michigan, Verenigde Staten, 49015
        • Associated Internal Medicine Specialists
      • Kalamazoo, Michigan, Verenigde Staten, 49009
        • Rheumatology Pc
    • Mississippi
      • Jackson, Mississippi, Verenigde Staten, 39202
        • Arthritis Associates Of Mississippi
    • Missouri
      • St.Louis, Missouri, Verenigde Staten, 63131
        • Physician Groups, Lc Dba
    • Nevada
      • Reno, Nevada, Verenigde Staten, 89502
        • Arthritis Center of Reno
    • New Hampshire
      • Dover, New Hampshire, Verenigde Staten, 03820
        • Seacoast Arthritis And Osteoporosis Center
      • Nashua, New Hampshire, Verenigde Staten, 03060
        • Nashua Rheumatology
    • New Mexico
      • Las Cruces, New Mexico, Verenigde Staten, 88011
        • Arthritis and Osteoporosis Associates of New Mexico
    • New York
      • Lake Success, New York, Verenigde Staten, 11042
        • North Shore Lij Health System
      • Mineola, New York, Verenigde Staten, 11501
        • Winthrop University Hospital
      • Smithtown, New York, Verenigde Staten, 11787
        • Rheumatology Associates of Long Island
    • North Carolina
      • Asheville, North Carolina, Verenigde Staten, 28803
        • Asheville Rheumatology & Osteoporosis Research Asso P. A.
      • Statesville, North Carolina, Verenigde Staten, 28625
        • Carolina Pharmaceutical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73109
        • Health Research Institute
      • Oklahoma City, Oklahoma, Verenigde Staten, 73103
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73112
        • Lynn Health Sciences Institute
    • Pennsylvania
      • Bethlehem, Pennsylvania, Verenigde Staten, 18015
        • East Penn Rheumatology Associates, P.C.
      • Duncansville, Pennsylvania, Verenigde Staten, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, Verenigde Staten, 19610
        • Clinical Research Center of Reading, LLP
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29406
        • Low Country Rheumatology, PA
      • Columbia, South Carolina, Verenigde Staten, 29204
        • Columbia Arthritis Center, P.A.
    • Texas
      • Austin, Texas, Verenigde Staten, 78758
        • Lovelace Scientific Resources, Inc.
      • Dallas, Texas, Verenigde Staten, 75246
        • Arthritis Centers Of Texas
      • Houston, Texas, Verenigde Staten, 77004
        • Rheumatic Disease Clinical Research Center, LLC
    • Virginia
      • Chesapeake, Virginia, Verenigde Staten, 23320
        • Center For Arthritis & Rheumatic Diseases, Pc
    • Washington
      • Spokane, Washington, Verenigde Staten, 99202
        • Rockwood Research Center
    • West Virginia
      • Clarksburg, West Virginia, Verenigde Staten, 26301
        • Mountain State Clinical Research
    • Wisconsin
      • Glendale, Wisconsin, Verenigde Staten, 53217
        • Rheumatic Disease Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Adalimumab
Geneesmiddel: Adalimumab
Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
Andere namen:
  • Humira
Actieve vergelijker: Abatacept
Geneesmiddel: Abatacept
Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
Andere namen:
  • Orencia
  • BMS-188667

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bristol-Myers Squibb

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2009

Primaire voltooiing (Werkelijk)

1 oktober 2011

Studie voltooiing (Werkelijk)

1 november 2012

Studieregistratiedata

Eerst ingediend

29 juni 2009

Eerst ingediend dat voldeed aan de QC-criteria

29 juni 2009

Eerst geplaatst (Schatting)

30 juni 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

4 februari 2014

Laatste update ingediend die voldeed aan QC-criteria

3 januari 2014

Laatst geverifieerd

1 januari 2014

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IM101-235

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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