Number of ACR 20 Responders in DB Period
ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Number of ACR 50 Responders in DB Period
ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
Number of ACR 70 Responders in DB Period
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
ACR Numeric Values (ACR-N)
The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.
ACR-N Area Under The Curve (AUC) on Day 180 and Day 360
The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N.
Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180
Percentage change = 100*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])
Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360
Percentage change = 100*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function [SAPF]), patient and physician global assessments of disease activity (Subject Global Assessment [SGA] and Physician Global Assessment [PGA]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein [CRP])
Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360
SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score.
Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360
A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100.
Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360
Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug.
Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy
Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy
Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods
Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region
Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region
Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region)
Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.
Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region)
Number of participants with ratio of VA/PRE <=3, <3 to <=9, and >9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.
Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360
Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360
Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360
Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360
Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360
Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360
Number of ACR 20 Responders in OL Period
ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
Number of ACR 50 Responders in the OL Period
ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
Number of ACR 70 Responders in the OL Period
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period
The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units.
Baseline Level of Serum Rheumatoid Factor Over Time in OL Period
Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.
Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period
Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point.
Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period
Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.
Mean Change From Baseline in sIL2-r Over Time in OL Period
Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.
Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period
Serum evaluations were carried out to evaluate participant serum CRP concentrations at baseline. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period
Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.
Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50.
Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period
The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49.
Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period
SF-36=PCS, MCS, & 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, & mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values & post-baseline (BL) values are presented for each post-BL visit & represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL.
Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period
The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51.
Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54.
Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53.
Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56.
Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55.
Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58.
Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57.
Mean BL General Health Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60.
Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59.
Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62.
Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61.
Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64.
Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63.
Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66.
Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65.
Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period
SF-36 = PCS & MCS & 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 & a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL & post-BL values are presented for each post-BL visit & represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68.
Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period
SF-36=2 summaries (PCS & MCS) & 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 & a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67.