- Number of Participants With an Investigators Global Assessment Score of Clear or Almost Clear at Day 169 (Double-blind Period) [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
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).
- Mean Percentage of Change From Baseline in Target Lesion Score at Day 169 (Double-blind Period) [ Time Frame: From baseline to Day 169. ] [ Designated as safety issue: No ]
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. Results are presented as adjusted mean percentage difference, based on the Analysis of Covariance model, with treatment as factor and baseline value as covariate.
- Mean Change From Baseline in Physical Component Summary Score as Measured by the Short Form 36 at Day 169 (Double-blind Period) [ Time Frame: From baseline to Day 169. ] [ Designated as safety issue: No ]
The Short Form 36 is a 36-item instrument that covers 8 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--which are 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 = post-baseline - baseline value; a higher value signifies improvement. Mean change from baseline = postbaseline - baseline value.
- Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short Form 36 at Day 169 (Double-blind Period) [ Time Frame: From Baseline to Day 169 ] [ Designated as safety issue: No ]
The Short Form 36 is a 36-item instrument that covers 8 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--which are 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 = post-baseline - baseline value; a higher value signifies improvement. Mean change from baseline=postbaseline - baseline value.
- Number of Participants Achieving a Reduction of at Least 0.3 Unit From Baseline in Health Assessment Questionnaire Disability Index Scores at Day 169 (Double-blind Period) [ Time Frame: From baseline to Day 169 ] [ Designated as safety issue: No ]
The Health Assessment Questionnaire disability index assesses a participant's ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: without any difficulty (0), with some difficulty (1), with much difficulty (2), to unable to do (3).
- Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs (Double-blind Period) [ Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to 56 days after the last dose of double-blind period or start of open-label period, whichever occurred earlier. ] [ Designated as safety issue: Yes ]
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.
- Number of Participants With Marked Abnormalities in Hematology (Double-blind Period) [ Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to 56 days after the last dose of double-blind period or start of open-label period, whichever occurred earlier. ] [ Designated as safety issue: Yes ]
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.
- Number of Participants With Marked Abnormalities in Hematology (Double-blind Period)(Continued) [ Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to 56 days after the last dose of double-blind period or start of open-label period, whichever occurred earlier. ] [ Designated as safety issue: Yes ]
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.
- Number of Participants With Marked Abnormalities in Serum Chemistry (Double-blind Period) [ Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to 56 days after the last dose of double-blind period or start of open-label period, whichever occurred earlier. ] [ Designated as safety issue: Yes ]
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.
- Number of Participants With Marked Abnormalities in Serum Chemistry (Double-blind Period)(Continued) [ Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to 56 days after the last dose of double-blind period or start of open-label period, whichever occurred earlier. ] [ Designated as safety issue: Yes ]
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 <LLN.
- Number of Participants With Marked Abnormalities in Serum Chemistry (Double-blind Period) (Continued) [ Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to 56 days after the last dose of double-blind period or start of open-label period, whichever occurred earlier. ] [ Designated as safety issue: Yes ]
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.
- Number of Participants With Marked Abnormalities in Urinalysis (Double-blind Period) [ Time Frame: Events recorded at each participant encounter, from start of study drug therapy up to 56 days after the last dose of double-blind period or start of open-label period, whichever occurred earlier. ] [ Designated as safety issue: Yes ]
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).
- Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)(Double-blind Period) [ Time Frame: Day 1 prior to the first dose of open-label period ] [ Designated as safety issue: Yes ]
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].
- Mean Serum Concentrations of Abatacept (Double-blind Period) [ Time Frame: Blood samples were collected prior to study medication infusion on Days 1, 15, 29, 57, 85, 113, 141 and Day 169. ] [ Designated as safety issue: No ]
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.
- Mean Serum Trough Concentrations (Cmin) of Abatacept (Double-blind Period) [ Time Frame: Blood samples were collected prior to study medication infusion on Day 1, 15, 29, 57, 85, 113, 141 and Day 169. ] [ Designated as safety issue: No ]
Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.
- Population PK (POPPK) Analysis of the PK Parameters (Double-blind Period) [ Time Frame: Blood samples were collected just prior to the administration of the intravenous infusion on Days 1, 15, 29, 57, 85, 113, 141, and 169. ] [ Designated as safety issue: No ]
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.
- Number of Participants With ACR 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729 (Open-label Period) [ Time Frame: From Day 169, Day 365 and Day 729 during the open-label period ] [ Designated as safety issue: No ]
A participant was an ACR 20 responder if: the counts for both tender and swollen joints had reduced by 20% or more from baseline; and 3 out of the following 5 assessments showed reduction of 20% or more from baseline: participant's assessment of disease activity (VAS), participant's global assessment of disease activity, IGA, participant's assessment of physical function by HAQ-DI, and DAS28-CRP. Responders with ACR 50, 70 and 90 showed 50%, 70% and 90% reduction in ACR score respectively from baseline on above mentioned criterion.
- Number of Participants With an Investigators Global Assessment Score of Clear or Almost Clear at Days 365 and 729 (Open-label Period) [ Time Frame: From Days 169, 365, and 729 during the open-label period. ] [ Designated as safety issue: No ]
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).
- Mean Percentage Change From Baseline in Target Lesion Score at Day 365 and Day 729(Open-label Period) [ Time Frame: From baseline to Days 365 and 729 during the open-label period. ] [ Designated as safety issue: No ]
TL score was a measurement of the degree of erythema, induration, and scale of at least 2 cm in diameter of psoriatic lesion selected as a target for response throughout of 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. Results are presented as adjusted mean percentage difference, based on the ANCOVA model, with treatment as factor and baseline value as covariate.
- Mean Change From Baseline in Physical Component Summary Score as Measured by the Short Form 36 at Days 365 and 729 (Open-label Period) [ Time Frame: From Baseline to Days 365 and 729 during the open-label period. ] [ Designated as safety issue: No ]
The Short Form 36 is a 36-item instrument that covers 8 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--which are 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 = post-baseline - baseline value; a higher value signifies improvement.
- Mean Change From Baseline in Mental Component Summary Score as Measured by the Short Form 36 at Days 365 and 729 (Open-label Period) [ Time Frame: From baseline to Days 365 and 729 during the open-label period. ] [ Designated as safety issue: No ]
The Short Form 36 is a 36-item instrument that covers 8 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--which are 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 = post-baseline - baseline value; a higher value signifies improvement.Mean change from baseline = postbaseline - baseline value; a higher value signifies improvement.
- Number of Participants Achieving a Reduction of at Least 0.3 Unit From Baseline in Health Assessment Questionnaire - Disability Index Score at Days 365 and 729 (Open-label Period) [ Time Frame: From baseline to Days 365 and 729 during the open-label period. ] [ Designated as safety issue: No ]
Participants assessed their own ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity over a period by marking their response on a questionnaire. Possible responses/scores of HAQ-DI included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a >= 0.3 unit decrease (improvement) in index scores from baseline to weeks 48 and 96 (days 365 and 729).
Purpose
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