| Primary | Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (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 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. | Intent-to-treat population. Participants who discontinued the study due to lack of efficacy (ie, worsening rheumatoid arthritis) were considered ACR 20 nonresponders at all subsequent time points. For all subjects who discontinued for other reasons, their last ACR 20 response was carried forward. | Posted | | Number | | Participants | | Day 180 | | | | ID | Title | Description |
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| OG000 | DB Abatacept 10 mg/kg + Methotrexate | Participants received a weight-tiered dose of 10 mg/kg of abatacept, administered intravenously(IV) monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | DB Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period. | | OG002 | DB Placebo + Methotrexate | Participants in the DB study received a placebo that was administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | <0.001 | | Point Estimate of Difference | 25.6 | | | 2-Sided | 95 | 12.8 | 38.4 | | | | No | Superiority or Other | | | | | Chi-squared | | 0.31 |
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| Secondary | 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. | Participants who received at least 1 infusion of study medication | Posted | | Number | | Participants | | Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360 | | | | ID | Title | Description |
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| OG000 | DB Abatacept 10 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept administered monthly IV plus methotrexateParticipants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | DB Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | 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. | Participants who received at least 1 infusion of study medication | Posted | | Number | | Participants | | Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | 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. | Participants who received at least 1 infusion of study medication | Posted | | Number | | Participants | | Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | 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. | Participants who received at least 1 infusion of study medication | Posted | | Mean | Standard Deviation | units on a scale | | Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | 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. | | Posted | | Mean | Standard Error | percentage*days | | Baseline and Day 180; Baseline and Day 360 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | 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]) | Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points. | Posted | | Mean | Standard Error | percentage change | | Baseline, Day 180 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate |
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| Secondary | 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]) | Number of Participants Analyzed = Participants who received at least 1 infusion of study medication; n = subset of participants who had given measurement at both time points. | Posted | | Mean | Standard Error | percentage change | | Baseline, Day 360 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate |
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| Secondary | 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. | Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint. | Posted | | Mean | Standard Error | units on a scale | | Baseline, Day 180, Day 360 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | 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 Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint. | Posted | | Mean | Standard Error | Percentage of Change on mHAQ scale | | Baseline, Day 180, Day 360 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360 | | | Posted | | Number | | participants | | Day 180, Day 360 | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG002 | Double-Blind (DB) Placebo + Methotrexate |
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| Secondary | 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. | | Posted | | Number | | Participants | | From the start of study through the end of the double-blind period (at 12 months) | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | |
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| Secondary | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy | | Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement. | Posted | | Number | | Participants | | From the start of study up to 60 days post the end of the 12-month double-blind period | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Primary | Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period | The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics. | All treated participants. | Posted | | Number | | Participants | | Day 360 to Day 3,060 | | | | ID | Title | Description |
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| OG000 | OL Abatacept: Original 10 mg / kg Group | Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg / kg Group | Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. | | OG002 | OL Abatacept: Original Placebo Group | |
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| Primary | Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug. | All treated OL participants. | Posted | | Number | | Participants | | Day 360 to Day 3060 | | | | ID | Title | Description |
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| OG000 | OL Abatacept (10 mg / kg) | OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. |
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| Primary | Number of Participants With AEs of Special Interest in OL Period | AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest were those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion. | All treated OL participants. | Posted | | Number | | Participants | | Day 360 to Day 3060 | | | | ID | Title | Description |
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| OG000 | OL Abatacept (10 mg / kg) | OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. |
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| Primary | Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period | Time-matched baseline (Day 0) values and post-baseline values 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 data for these cohorts are presented in Outcome Measure 6. | All treated OL participants. Participants were grouped according to the treatment they received in DB study. n=the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800 | | | | ID | Title | Description |
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| OG000 | OL Abatacept: Original 10 mg / kg Group | Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg / kg Group | Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. |
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| Primary | Mean Change From Baseline (BL) in IgA Over Time in OL Period | Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | mg/dL | | Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800 | | | | ID | Title | Description |
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| OG000 | OL Abatacept: Original 10 mg / kg Group | Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg / kg Group | Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. | |
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| Secondary | Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy | | Number of Participants Analyzed=All treated participants. n=number of participants evaluated for given measurement. | Posted | | Number | | Participants | | From the start of study up to 60 days post the end of the 12-month double-blind period | | | | ID | Title | Description |
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| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods | | | Posted | | Number | | participants | | Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period) | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG002 | Double-Blind (DB) Placebo + Methotrexate |
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| Secondary | Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region | | Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint. | Posted | | Geometric Mean | Standard Deviation | titers | | Baseline, Days 30, 90, 180, 270, 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
| |
| Secondary | Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region | | Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint. | Posted | | Geometric Mean | Standard Deviation | titers | | Baseline, Days 30, 90, 180, 270, 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
| |
| Secondary | 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. | Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint. | Posted | | Number | | participants | | Baseline, Days 30, 90, 180, 270, 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Primary | Baseline Immunoglobulin G (IgG) Over Time in OL Period | 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 data for these cohorts are presented in Outcome Measure 8. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg / kg Group | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg / kg Group | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. |
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| Primary | Mean Change From Baseline (BL) in IgG Over Time in OL Period | Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | mg/dL | | Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg / kg Group | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg / kg Group | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG002 |
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| Primary | Baseline Immunoglobulin M (IgM) Over Time in OL Period | Time-matched baseline (Day 0) values and post-baseline values 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 data for these cohorts are presented in Outcome Measure 10. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Day 0) and Days 360, 720,1080,1440, and 1800 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg / kg Group | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg / kg Group | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. |
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| Secondary | 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. | Number of Participants Analyzed=treated participants; n=number of participants with both baseline and post-baseline measurements at timepoint. | Posted | | Number | | participants | | Baseline, Days 30, 90, 180, 270, 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360 | | Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint. | Posted | | Mean | 95% Confidence Interval | IU/mL | | Baseline, Day 180, Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360 | | Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint. | Posted | | Mean | 95% Confidence Interval | pg/mL | | Baseline, Day 180, Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360 | | Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint. | Posted | | Mean | 95% Confidence Interval | pg/mL | | Baseline, Day 180, Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360 | | Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint. | Posted | | Mean | 95% Confidence Interval | ng/mL | | Baseline, Day 180, Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360 | | Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint. | Posted | | Mean | 95% Confidence Interval | ng/mL | | Baseline, Day 180, Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360 | | Number of Participants Analyzed=total number of participants in each treatment group. n=number of treated Participants with measurement at baseline and given timepoint. | Posted | | Mean | 95% Confidence Interval | ng/mL | | Baseline, Day 180, Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX) | Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. | | OG001 | Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate | Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period. |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. N = number of participants analyzed and n = the number of participants with measurements for that time point. | Posted | | Number | | Participants | | Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg Group | Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg Group |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point. | Posted | | Number | | Participants | | Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg Group | Participants in the DBperiod received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg Group | |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N=number of participants analyzed; n=the number of participants with measurements for that time point. | Posted | | Number | | Participants | | Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. N =number of participants analyzed; n=the number of participants with measurements for that time point. | Posted | | Number | | Participants | | Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | IU/mL | | Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | IU/mL | | Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | |
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| Primary | Mean Change From Baseline (BL) in IgM in OL Period | Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9. | All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | mg/dL | | Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg Group | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by intravenous IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg Group | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG002 |
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| Primary | Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period | | All treated OL participants. | Posted | | Number | | Participants | | Day 360 to Day 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept (10 mg / kg) | OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. |
| | |
| Primary | Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period | | All treated OL participants. | Posted | | Number | | Participants | | Day 360 to Day 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept (10 mg / kg) | OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. |
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| Primary | Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period | | All treated OL participants. | Posted | | Number | | Participants | | Day 360 to Day 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept (10 mg / kg) | OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. |
| | |
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg /kg | Participants in the DB period received a weight-tiered dose of 2 mg/kg abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. |
|
| Primary | Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period | | All treated OL participants. | Posted | | Number | | Participants | | Day 360 to Day 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept (10 mg / kg) | OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by I) infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. |
| |
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | pg/mL | | Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG002 | OL Abatacept: Original Placebo |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | mg/dL | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG002 |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg / kg Group | Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg / kg Group | Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. | | OG001 |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg / kg Group | Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg / kg Group |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n=the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
|
| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg /kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n =the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the DB study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg | |
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| Secondary | 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. | All treated OL participants. Participants were grouped according to the treatment they received in the double-blind (DB) study. n = the number of participants with measurements for that time point. | Posted | | Mean | Standard Error | Units on a Scale | | Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060 | | | | ID | Title | Description |
|---|
| OG000 | OL Abatacept: Original 10 mg/kg | Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg. | | OG001 | OL Abatacept: Original 2 mg/kg |
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