| Primary | Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest | Presp=prespecified; acute= ≤1 hour after start of infusion; periinfusional= ≤24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug. | All participants who received at least 1 infusion of abatacept during the long-term period. | Posted | | Number | | Participants | | From Day 169 to Day 729 | | | | ID | Title | Description |
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| OG000 | All Treated Participants | Long-term period: All participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days. |
| | | Title | Denominators | Categories |
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| Deaths | | | | SAEs | | | | Drug-related SAEs | | |
| |
| Secondary | Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 | An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein. | All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response) | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At Days 365 and 729 from Baseline | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days. | |
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| Secondary | Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729 | IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates). | All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with a response) | Posted | | Number | | Participants | | From Day 169 to Days 365 and 729 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days. | | OG001 |
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| Secondary | Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729 | Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value. | All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. | Posted | | Mean | Standard Deviation | Percentage of change | | From Baseline to Days 365 and 729 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days. | | OG001 | Abatacept 10/10 | Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days. |
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| Secondary | Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729 | PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement. | | Posted | | Mean | Standard Error | Units on a scale | | At Days 365 and 729 from baseline | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days. | | OG001 | Abatacept 10/10 | Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days. |
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| Secondary | Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729 | Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved. | All participants who received at least 1 infusion of abatacept in the long-term (open-label) period. (n=number of participants with responses available) | Posted | | Number | | Participants | | Days 365 and 729 from baseline | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days. | | OG001 |
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| Secondary | Short-term Period: Number of Participants With Marked Abnormalities in Hematology | LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN. | All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively). | Posted | | Number | | Participants | | From Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg). |
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| Primary | Short-term Period: Number of Participants With ACR 20 Response at Day 169 | An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant's assessment of disease activity, participant's global assessment of disease activity, investigator's global assessment of disease activity, participant's assessment of physical function by HAQ-DI, and Disease Activity Score 28-C reactive protein. | All randomized participants who received at least 1 infusion of study medication in the double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication. | Posted | | Number | | Participants | | At Day 169 from Baseline | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg). |
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| Secondary | Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued) | LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL. | All participants who received at least 1 infusion of study medication during double-blind period. n=number of participants with evaluable results (each arm respectively). | Posted | | Number | | Participants | | From Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants who received iv infusions of abatacept (30 mg/kg-calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | |
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| Secondary | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry | ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx. | All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively). | Posted | | Number | | Participants | | Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg). |
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| Secondary | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or \ | All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results (each arm respectively). | Posted | | Number | | Participants | | Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 |
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| Secondary | Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued) | LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value. | All participants who received at least 1 infusion of study medication during the double-blind period. n=number of participants with evaluable results. | Posted | | Number | | Participants | | From Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg). |
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| Secondary | Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis | Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4). | All participants who received at least 1 infusion of study medication during the double-blind period. n = number of participants with evaluable results (each arm respectively). | Posted | | Number | | Participants | | From Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg). |
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| Secondary | Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. | All participants who received at least 1 infusion of study medication during the double-blind period. | Posted | | Number | | Participants | | From Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | |
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| Secondary | Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169 | Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates). | All randomized participants who received at least 1 infusion of study medication in double-blind (short-term) period. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication. | Posted | | Number | | Participants | | At Day 169 from Baseline | | | | ID | Title | Description |
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| OG000 | Abatacept 30/10 | Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 |
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| Secondary | Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 | Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value. | All randomized participants who received at least 1 infusion of study drug in double-blind (short-term) period. Only participants with both baseline and postbaseline values included. Missing values at Day 169 were imputed using the last observation carried forward values, except for participants with only baseline value. | Posted | | Mean | Standard Error | Percentage of change | | At Day 169 from Baseline | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg). | | OG001 | Abatacept 10/10 | |
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| Secondary | Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C) | Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody]. | Participants who received abatacept and for whom baseline and at least 1 additional measurement were available during the double-blind (short-term) period. | Posted | | Number | | Participants | | From Baseline to Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 169. All participants received a dose based on their screening visit weight as per by rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg). |
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| Secondary | Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169 | PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement. | All randomized and treated participants with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations. | Posted | | Mean | Standard Error | Units on a scale | | At Day 169 from Baseline | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 |
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| Secondary | Short-term Period: Mean Serum Concentrations of Abatacept | Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis. | All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively. | Posted | | Mean | Standard Deviation | µg/mL | | Days 1, 15, 29, 57, 85, 113, 141, and 169 | | | | ID | Title | Description |
|---|
| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg). |
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| Secondary | Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept | Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data. | All participants who received at least 1 infusion of study medication and were evaluable for PK analysis during double-blind period. n= number of participants with evaluable PK results in each arm respectively. | Posted | | Geometric Mean | Full Range | µg/mL | | Days 1, 15, 29, 57, 85, 113, 141, and 169 | | | | ID | Title | Description |
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| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg). |
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| Secondary | Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters | PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data. | | Posted | | | | | | Days 1, 15, 29, 57, 85, 113, 141, and 169 | | | | ID | Title | Description |
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| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg). |
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| Secondary | Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169 | PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement. | All randomized participants who received treatment and with baseline and postbaseline measurements at Day 169. Missing values were imputed by Last Observation Carried Forward, except for participants with only baseline observations. | Posted | | Mean | Standard Error | Units on a scale | | At Day 169 from Baseline | | | | ID | Title | Description |
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| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg -calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 |
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| Secondary | Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169 | The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability. | All randomized participants who received at least 1 infusion of study medication at any time. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication. | Posted | | Number | | Participants | | At Day 169 from Baseline | | | | ID | Title | Description |
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| OG000 | Abatacept 30/10 | Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg. | | OG001 | Abatacept 10/10 | Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000mg). |
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