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Trial record 36 of 115 for:    Rheumatoid Arthritis | "Connective Tissue Disease" | "Abatacept"

Abatacept Versus Adalimumab Head-to-Head

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ClinicalTrials.gov Identifier: NCT00929864
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : January 3, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE June 30, 2009
Results First Submitted Date  ICMJE November 14, 2013
Results First Posted Date  ICMJE January 3, 2014
Last Update Posted Date February 4, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
The proportion of subjects meeting the ACR criteria of 20% improvement (ACR 20) after 12 months of treatment [ Time Frame: Day 365 ]
Change History Complete list of historical versions of study NCT00929864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2013)
  • Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population [ Time Frame: 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.
  • Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2009)
  • The comparative safety profile of 12 and 24 months treatment of abatacept vs. adalimumab estimated by the rate of SAEs, serious infections, and pre-specified opportunistic infections [ Time Frame: Day 1, Day 365, Day 729 ]
  • Radiographic effect of 12 and 24 months Tx of abatacept vs adalimumab estimated by non-progressors rate from baseline using smallest detectable difference in joint damage measured by radiographic evaluation using modified vanderHeijde total Sharp score [ Time Frame: Day 1, Day 365, Day 729 ]
  • The comparative retention profile of 12 months (Day 365) and 24 months (Day 729) treatment of abatacept vs. adalimumab estimated by the rate of discontinuation for any cause [ Time Frame: Day 1, Day 365, Day 729 ]
  • The comparative tolerability of 12 months (Day 365) and 24 months (Day 729) treatment of abatacept vs. adalimumab estimated by the rate of injection site reactions and induction of autoantibodies. [ Time Frame: Day 1, Day 365, Day 729 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abatacept Versus Adalimumab Head-to-Head
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Abatacept
    Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
    Other Names:
    • Orencia
    • BMS-188667
  • Drug: Adalimumab
    Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
    Other Name: Humira
Study Arms  ICMJE
  • Active Comparator: Abatacept
    Intervention: Drug: Abatacept
  • Active Comparator: Adalimumab
    Intervention: Drug: Adalimumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2013)
869
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2009)
648
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Chile,   Peru,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00929864
Other Study ID Numbers  ICMJE IM101-235
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP