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Abatacept Versus Adalimumab Head-to-Head

3 gennaio 2014 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

869

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Adalimumab
Droga: Adalimumab
Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
Altri nomi:
  • Umira
Comparatore attivo: Abatacept
Droga: Abatacept
Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
Altri nomi:
  • Orencia
  • BMS-188667

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2009

Completamento primario (Effettivo)

1 ottobre 2011

Completamento dello studio (Effettivo)

1 novembre 2012

Date di iscrizione allo studio

Primo inviato

29 giugno 2009

Primo inviato che soddisfa i criteri di controllo qualità

29 giugno 2009

Primo Inserito (Stima)

30 giugno 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 febbraio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 gennaio 2014

Ultimo verificato

1 gennaio 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IM101-235

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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