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Abatacept Versus Adalimumab Head-to-Head

3. januar 2014 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

869

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Adalimumab
Medicin: Adalimumab
Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
Andre navne:
  • Humira
Aktiv komparator: Abatacept
Medicin: Abatacept
Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
Andre navne:
  • Orencia
  • BMS-188667

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

29. juni 2009

Først indsendt, der opfyldte QC-kriterier

29. juni 2009

Først opslået (Skøn)

30. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IM101-235

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med Abatacept

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Betingelser

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