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Trial record 6 of 137 for:    "Connective Tissue Disease" | "Abatacept"

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00430677
Recruitment Status : Terminated (Terminated due to failure to meet the primary efficacy endpoint in the Short-term Period)
First Posted : February 2, 2007
Results First Posted : May 11, 2012
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: Corticosteroids (prednisone or prednisolone)
Drug: Abatacept
Drug: Mycophenolate mofetil (MMF)
Enrollment 423
Recruitment Details  
Pre-assignment Details 423 participants were enrolled and screened; 300 were randomized. Of the 228 participants who completed the short-term period, 211 received treatment in the long-term extension period. A total of 166 participants (78.7%) remained in the study at the time of study termination by the sponsor.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent. Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent. Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Period Title: Short-term Period
Started 99 [1] 99 [2] 100
Completed 76 [3] 74 [3] 78 [3]
Not Completed 23 25 22
Reason Not Completed
Death             1             1             5
Adverse Event             15             13             9
Lack of Efficacy             5             6             4
Withdrawal by Subject             1             1             2
Participant no longer met study criteria             1             1             2
Poor compliance/ noncompliance             0             1             0
Pregnancy             0             2             0
[1]
1 participant died before receiving the first dose of study medication
[2]
1 participant took infliximab on day 1 and was discontinued before receiving study medication.
[3]
Completed the short-term period
Period Title: Long-term Extension Period
Started 70 67 74
Completed 10 [1] 9 [1] 11 [1]
Not Completed 60 58 63
Reason Not Completed
Death             1             0             0
Adverse Event             3             2             5
Lack of Efficacy             5             3             8
Lost to Follow-up             1             1             1
Withdrawal by Subject             5             1             2
Pregnancy             1             1             0
Administrative reason by sponsor             41             49             46
Not specified             2             1             1
Poor compliance/noncompliance             1             0             0
[1]
Completed the long-term extension period
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo Total
Hide Arm/Group Description Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Total of all reporting groups
Overall Number of Baseline Participants 99 99 100 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 99 participants 100 participants 298 participants
16 - 29 years 55 52 46 153
30 - 39 years 28 30 33 91
40 - 49 years 10 10 18 38
50 - 59 years 5 6 2 13
>= 60 years 1 1 1 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 99 participants 100 participants 298 participants
Female
84
  84.8%
86
  86.9%
81
  81.0%
251
  84.2%
Male
15
  15.2%
13
  13.1%
19
  19.0%
47
  15.8%
Race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 99 participants 100 participants 298 participants
White 28 45 38 111
Black/African American 6 3 5 14
American Indian/Alaska Native 0 1 0 1
Native Hawaiian/Other Pacific Islander 1 0 0 1
Other Asian 60 49 55 164
Other 4 1 2 7
Weight, Group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 99 participants 99 participants 100 participants 298 participants
<60 kg 54 55 45 154
60 - 100 kg 42 43 51 136
>100 kg 3 1 4 8
1.Primary Outcome
Title Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period
Hide Description Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.
Time Frame Day 1 (randomization) to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: days
NA [1]  NA [1]  NA [1] 
[1]
The Kaplan-Meier median time to confirmed CRR was not reached due to a small number of events (such as, fewer than 50% of participants achieved confirmed CRR).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept 30/10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.746
Comments The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.60 to 2.03
Estimation Comments Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept 10/10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
0.89 to 2.83
Estimation Comments Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.
2.Secondary Outcome
Title Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period
Hide Description Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.
Time Frame Day 1 to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment. Participants who discontinued early without meeting the confirmed CRR criteria were imputed as nonresponders.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycofenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
Placebo (dextrose 5% in water) or normal saline by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: Participants
22 27 20
3.Secondary Outcome
Title Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period
Hide Description Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.
Time Frame At Month 12 from Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: Participants
9 11 8
4.Secondary Outcome
Title Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)
Hide Description RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts.
Time Frame Day 1 (randomization) to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Median (95% Confidence Interval)
Unit of Measure: Days
141
(88 to 169)
136
(92 to 171)
144
(113 to 198)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept 30/10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.91 to 1.78
Estimation Comments Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept 10/10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.91 to 1.77
Estimation Comments Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.
5.Secondary Outcome
Title Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period
Hide Description CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate [GFR] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported.
Time Frame At Month 12 from Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Participants
38
(28.8 to 48.0)
37
(27.8 to 46.9)
31
(21.9 to 40.1)
6.Secondary Outcome
Title Number of Months CRR Was Maintained During Short-term Period
Hide Description Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR.
Time Frame Day 1 (randomization) to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received participants.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Median (Full Range)
Unit of Measure: Months
0
(0 to 11)
0
(0 to 8)
0
(0 to 11)
7.Secondary Outcome
Title Baseline Renal Function Over Time During Short-term Period
Hide Description Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A negative value indicates worsening.
Time Frame Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
Hide Outcome Measure Data
Hide Analysis Population Description
n= Number of participants with measurements for that time point. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: milliliters per minute (mL/min)/1.73 m^2
Baseline (Day 1) for Day 15 (n=98,94,98) 92.57  (36.57) 99.09  (35.41) 91.01  (29.60)
Baseline (Day 1) for Day 29 (n=98,95,98) 93.08  (36.14) 98.56  (36.26) 91.23  (29.33)
Baseline (Day 1) for Day 57 (n=94, 89, 96) 91.54  (35.99) 98.76  (35.96) 91.58  (28.93)
Baseline (Day 1) for Day 85 (n=90, 91, 93) 94.53  (35.53) 100.22  (35.50) 92.76  (29.01)
Baseline (Day 1) for Day 113 (n=91, 83, 91) 94.43  (35.80) 101.23  (35.38) 92.41  (28.15)
Baseline (Day 1) for Day 141 (n=89, 83, 90) 93.62  (35.74) 101.05  (35.73) 92.83  (29.10)
Baseline (Day 1) for Day 169 (n=83, 82, 85) 94.83  (36.10) 101.95  (35.82) 92.56  (29.85)
Baseline (Day 1) for Day 197 (n=84, 81, 87) 94.55  (35.98) 101.85  (36.26) 92.69  (29.51)
Baseline (Day 1) for Day 225 (n=84, 81, 84) 94.87  (35.82) 101.64  (36.26) 93.25  (29.75)
Baseline (Day 1) for Day 253 (n=81, 76, 81) 94.89  (36.24) 101.25  (36.67) 93.38  (30.07)
Baseline (Day 1) for Day 281 (n=78, 77, 80) 94.17  (36.55) 102.64  (36.76) 93.13  (30.13)
Baseline (Day 1) for Day 309 (n=77, 76, 78) 94.74  (36.81) 100.64  (33.80) 92.71  (30.23)
Baseline (Day 1) for Day 337 (n=74, 75, 79) 95.51  (37.30) 101.00  (33.89) 92.90  (30.13)
Baseline (Day 1) for Day 365 (n=75, 73, 78) 95.04  (37.24) 101.30  (34.21) 93.03  (30.53)
8.Secondary Outcome
Title Change in Renal Function From Baseline Over Time During Short-term Period
Hide Description Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value.
Time Frame Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized and treated subjects). n= Number of participants with both baseline and post-baseline measurements for that time point.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Error)
Unit of Measure: milliliters per minute (mL/min)/1.73 m^2
Day 15; (n=98,94,98) -0.24  (2.08) 1.15  (2.11) 0.62  (1.41)
Day 29 (n=98, 95, 98) 2.26  (1.87) 4.51  (2.60) 1.70  (1.88)
Day 57 (n=94 89 96) 5.96  (2.13) 7.28  (3.38) 2.38  (2.27)
Day 85 (n=90, 91, 93) 8.56  (2.88) 6.20  (3.30) 2.89  (2.30)
Day 113 (n=91, 83, 91) 5.31  (2.73) 10.23  (4.11) 4.12  (2.70)
Day 141 (n=89, 83, 90) 8.33  (2.74) 7.90  (3.00) 3.62  (2.28)
Day 169 (n=83, 82, 85) 8.12  (2.70) 10.55  (3.46) 7.34  (2.31)
Day 197 (n=84, 81, 87) 7.71  (2.73) 10.67  (2.78) 6.79  (2.25)
Day 225 (n=84, 81, 84) 7.32  (2.78) 7.72  (2.77) 7.19  (2.23)
Day 253 (n=81, 76, 81) 4.70  (3.02) 7.22  (3.50) 5.86  (2.39)
Day 281 (n=78, 77, 80) 5.68  (2.83) 6.81  (3.37) 5.38  (2.30)
Day 309 (n=77, 76, 78) 6.34  (2.89) 9.53  (2.95) 6.00  (2.57)
Day 337 (n=74, 75, 79) 5.34  (2.60) 10.15  (2.74) 4.39  (2.86)
Day 365 (n=75, 73, 78) 5.17  (2.75) 11.03  (2.85) 5.68  (2.49)
9.Secondary Outcome
Title Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period
Hide Description SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.
Time Frame Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
n=Participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e., Change from Baseline greater than or equal to 0).
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=68, 67, 70) 0.34  (0.68) 0.27  (0.62) 0.29  (0.73)
Post Baseline Mean (n=68, 67, 70) 0.53  (1.04) 0.40  (0.80) 0.44  (0.81)
10.Secondary Outcome
Title Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period
Hide Description RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) <113 mg/mmol,, if the baseline ratio was <=339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio > 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n>=5.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Participants
45
(35.6 to 55.3)
39
(29.8 to 49.0)
33
(23.8 to 42.2)
11.Secondary Outcome
Title Change in SLICC/ACR Damage Index From Baseline During Short-term Period
Hide Description SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. Change from baseline=Postbaseline - baseline value.
Time Frame Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment and who had postbaseline and baseline measurements showing nonreversible changes (change from baseline >=0) in the SLICC-ACR Damage Index
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 68 67 70
Mean (Standard Error)
Unit of Measure: Units on a scale
0.17  (0.06) 0.11  (0.06) 0.13  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept 30/10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.13 to 0.19
Estimation Comments Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept 10/10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.18 to 0.14
Estimation Comments Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.
12.Secondary Outcome
Title Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period
Hide Description The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time Frame Baseline (Day 1), Days 85, 169, 253, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 1) for Day 85 (n=89, 91, 93) 42.18  (9.07) 43.80  (8.42) 42.68  (8.93)
Baseline (Day 1) for Day 169 (n=92, 94, 96) 42.04  (9.08) 44.17  (8.55) 42.48  (8.90)
Baseline (Day 1) for Day 253 (n=92, 94, 96) 42.04  (9.08) 44.17  (8.55) 42.48  (8.90)
Baseline (Day 1) for Day 365 (n=92, 94, 96) 42.04  (9.08) 44.17  (8.55) 42.48  (8.90)
13.Secondary Outcome
Title Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period
Hide Description The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time Frame Baseline (Day 1), Days 85, 169, 253, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Error)
Unit of Measure: Units on a scale
Day 85 (n=89, 91, 93) 4.17  (0.82) 2.61  (0.81) 2.86  (0.80)
Day 169 (n=92, 94, 96) 4.18  (0.85) 4.07  (0.84) 3.39  (0.83)
Day 253 (n=92, 94, 96) 4.23  (0.92) 4.80  (0.91) 3.45  (0.90)
Day 365 (n=92, 94, 96) 4.24  (0.91) 5.00  (0.91) 3.77  (0.90)
14.Secondary Outcome
Title Baseline Mental Component Summary of the Short SF-36 During Short-term Period
Hide Description The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time Frame Baseline (Day 1), Days 85, 169, 253, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 1) for Day 85 ( n=89, 91, 93) 42.18  (9.07) 43.80  (8.42) 42.68  (8.93)
Baseline (Day 1) for Day 169 (n=92,94,96) 44.08  (10.93) 41.84  (11.50) 42.59  (12.22)
Baseline (Day 1) for Day 253 ( n=92,94,96) 44.08  (10.93) 41.84  (11.50) 42.59  (12.22)
Baseline (Day 1) for Day 365 ( n=92,94,96) 44.08  (10.93) 41.84  (11.50) 42.59  (12.22)
15.Secondary Outcome
Title Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period
Hide Description The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
Time Frame Baseline (Day 1), Days 85, 169, 253, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward (LOCF), participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Error)
Unit of Measure: Units on a scale
Day 85 (n=89, 91, 93) 1.07  (1.11) 3.10  (1.08) 1.87  (1.08)
Day 169 (n=92, 94, 96) 2.90  (1.01) 5.08  (1.00) 3.69  (0.99)
Day 253 (n=92, 94, 96) 2.45  (1.00) 4.83  (0.99) 2.99  (0.98)
Day 365 (n=92, 94, 96) 2.62  (0.96) 4.23  (0.95) 2.84  (0.94)
16.Secondary Outcome
Title Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period
Hide Description A visual analogue scale (VAS) is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured. The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Time Frame Baseline (Day 1), Days 85, 169, 253, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 1) for Day 85 (n=90, 94, 95) 48.86  (25.97) 41.95  (22.81) 48.93  (25.47)
Baseline (Day 1) for Day 169 (n=92, 94, 97) 48.80  (25.96) 41.95  (22.81) 48.25  (25.68)
Baseline (Day 1) for Day 253 (n=92, 94, 97) 48.80  (25.96) 41.95  (22.81) 48.25  (25.68)
Baseline (Day 1) for Day 365 (n=92, 94, 97) 48.80  (25.96) 41.95  (22.81) 48.25  (25.68)
17.Secondary Outcome
Title Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period
Hide Description

A visual analogue scale is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured.

The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.

Time Frame Baseline (Day 1), Days 85, 169, 253, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; all randomized and treated subjects. To be included in analysis of change from baseline to time point with last observation carried forward, participants must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Error)
Unit of Measure: Units on a scale
Day 85 (n=90, 94, 95) -9.18  (2.37) -4.94  (2.33) -6.20  (2.33)
Day 169 (n=92, 94, 97) -7.18  (2.49) -9.52  (2.48) -4.71  (2.44)
Day 253 (n=92, 94, 97) -8.78  (2.59) -11.90  (2.57) -7.35  (2.53)
Day 365 (n=92, 94, 97) -12.21  (2.70) -12.32  (2.69) -11.07  (2.65)
18.Secondary Outcome
Title Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period
Hide Description The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.
Time Frame Baseline (Day 1), Days 85, 169, 253, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
n= Number of participants with both post-baseline and baseline measurements. Time-matched baseline (Day 1) values and post-baseline values are presented for each post-baseline visit and represent only that cohort of participants with measurement available at that post-baseline assessment.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Day 1) for Day 85 (n=90, 94, 95) 40.60  (13.75) 39.14  (13.54) 39.64  (13.00)
Baseline (Day 1) for Day 169 (n=92, 94, 97) 40.41  (13.67) 39.14  (13.54) 39.59  (12.87)
Baseline (Day 1) for Day 253 ( n=92, 94, 97) 40.41  (13.67) 39.14  (13.54) 39.59  (12.87)
Baseline (Day 1) for Day 365 ( n=92, 94, 97) 40.41  (13.67) 39.14  (13.54) 39.59  (12.87)
19.Secondary Outcome
Title Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period
Hide Description The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue.
Time Frame Baseline (Day 1), Days 85, 169, 253, and 365
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized and treated subjects). To be included in analysis of change from baseline to time point with last observation carried forward, subjects must have had a baseline measurement and at least 1 post baseline measurement. n= Number of participants with both post-baseline and baseline measurements.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Day 85 (n=90, 94, 95) -1.54  (1.20) -1.40  (1.18) -0.67  (1.18)
Day 169 (n=92, 94, 97) -2.68  (1.15) -1.69  (1.14) -1.08  (1.13)
Day 253 ( n=92, 94, 97) -3.54  (1.12) -2.95  (1.11) -3.06  (1.09)
Day 365 ( n=92, 94, 97) -4.20  (1.21) -3.21  (1.20) -4.79  (1.19)
20.Secondary Outcome
Title Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.
Time Frame From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: Participants
Deaths 5 2 7
SAEs 33 28 31
Related SAEs 20 19 15
AEs 93 89 94
Related AEs 61 53 55
Discontinued due to AEs 14 13 9
21.Secondary Outcome
Title Participants With AEs of Special Interest During the Short-term Period
Hide Description AEs of special interest were prospectively identified to be those that may be associated with the use of immunomodulatory agents. They are a subset of all AEs and may be either serious or non-serious.
Time Frame From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: Participants
Infections and Infestations 75 70 75
Malignancies 0 1 1
Autoimmune Disorders 4 5 3
Acute Infusional AEs 23 18 17
Peri-infusional AEs 23 18 17
22.Secondary Outcome
Title Participants With Marked Hematology Abnormalities During the Short-term Period
Hide Description LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. Low(↓)Hemoglobin:>3g/dL decrease from PTV; ↓Hematocrit:<0.75xPTV;↓Erythrocyte count:<0.75xPTV; high(↑)Platelet count:>1.5xULN;↓Platelet count:<0.67xLLN;↓Leukocyte count:<0.75X LLN;↑Leukocyte count:>1.25xULN;↓Absolute(AB)Neutrophils+Bands:<1.00x10^3c/uL;↑AB Lymphocyte count:>7.50x10^3 c/uL; ↓AB lymphocyte count:<0.750x10^3 c/uL;↑AB monocyte count:>2000/mm^3;↑AB basophil count:>400/mm^3;↑AB eosinophil count:>0.750x10^3 c/uL.
Time Frame From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: Participants
Low Hemoglobin (n=98, 98, 99) 6 3 9
Low Hematocrit (n=97, 98, 99) 5 1 7
Low Erythrocyte Count (n=98, 98, 99) 4 1 7
High Platelet Count (n=98, 98, 98) 1 0 1
Low Platelet Count (n=98, 98, 98) 1 3 1
High Leukocyte Count (n=98, 98, 99) 15 10 11
Low Leukocyte Count (n=98,98,99) 13 18 16
Low Absolute Neutrophils + Bands (n=98,98,99) 1 2 7
High Absolute Lymphocyte Count (n=98,98,99) 0 2 0
Low Absolute Lymphocyte Count (n=98, 98, 99) 47 32 53
High Absolute Monocyte Count (n=98, 98, 99) 1 1 1
High Absolute Basophil Count (n=98, 98, 99) 0 0 0
High Absolute Eosinophil Count (n=98, 98, 99) 0 3 0
23.Secondary Outcome
Title Participants With Marked Laboratory Abnormalities During the Short-term Period
Hide Description LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. ↑Serum Sodium:>1.05x ULN;↓Serum Potassium:<0.9x LLN;↑Serum Potassium:>1.1x ULN;↓Total Calcium:<0.8X LLN;↑Total Calcium:>1.2x ULN; ↓Serum Glucose(SG):<65 mg/dL;↑SG:>220 mg/dL;↓Fasting SG:<0.8x LLN;↑Fasting SG:>1.5x ULN;↓Total Protein:<0.9x LLN;↓Albumin:<0.9x LLN;↑Total Cholesterol:>2x PTV;↑Triglycerides:>=2.5x ULN;↑Fasting Triglycerides:>=2x ULN
Time Frame From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: Participants
High Serum Sodium (n=98, 98, 99) 1 2 0
Low Serum Potassium (n=98, 98, 99) 12 14 15
High Serum Potassium (n=98, 98, 99) 4 0 2
Low Total Calcium (n=98, 98, 99) 0 1 1
High Total Calcium (n=98, 98, 99) 1 2 1
Low Serum Glucose (n=98, 98, 99) 12 16 18
High Serum Glucose (n=98, 98, 99) 2 2 2
Low Fasting Serum Glucose (n=72, 73, 68) 3 2 0
High Fasting Serum Glucose (n=72, 73, 68) 1 1 0
Low Total Protein (n=98, 98, 99) 18 18 25
Low Albumin (n=98, 98, 99) 10 6 4
High Total Cholesterol (n=93,93,96) 2 0 1
High Triglycerides (n=71, 79, 75) 2 0 0
High Fasting Triglycerides (n=65, 64, 63) 3 0 0
24.Secondary Outcome
Title Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period
Hide Description

ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age.

Alkaline Phosphatase:>2x ULN; ↑Aspartate Aminotransferase: >3x ULN; ↑Alanine Aminotransferase : >3x ULN; G-Glutamyl Transferase : >2x ULN; ↑Total Bilirubin : >2x ULN or if PTV > ULN then > 4x PTV; ↑Blood Urea Nitrogen >2x PTV; ↑Creatinine >1.5x PTV.

Time Frame From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: Participants
High Alkaline Phosphatase 1 1 1
High Aspartate Aminotransferase 2 0 0
High Alanine Aminotransferase 7 4 1
High G-Glutamyl Transferase 7 7 5
High Total Bilirubin 0 0 0
High Blood Urea Nitrogen 5 1 6
High Creatinine 16 6 12
25.Secondary Outcome
Title Participants With Marked Abnormalities Urinalysis During the Short-term Period
Hide Description PTV=pretreatment value. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase , if missing PTV then use >=2+ (or, if value >=4, or if PTV=0 or 0.5, >=2 or if PTV=1, >=3, or if PTV=2 or 3, >=4).
Time Frame From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with both post-baseline and baseline measurements
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 98 99
Measure Type: Number
Unit of Measure: Participants
Urine Protein (n=99,98,99) 6 3 8
Urine Glucose (n=99,98,99) 1 3 0
Urine Blood (n=99,98,99) 16 19 17
Urine Leukocyte esterase (n=85,91,90) 10 8 8
26.Secondary Outcome
Title Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)
Hide Description [Not Specified]
Time Frame 0 - 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: mmHg
Day 1: SBP-before infusion; n=76,81,73 128.2  (16.34) 127.8  (15.86) 126.2  (16.88)
Day 1: SBP-1hour after infusion; n=69,78,70 127.7  (17.60) 126.7  (15.53) 126.0  (18.20)
Day 1: SBP-2.5 hours after infusion; n=79,81,76 127.1  (16.92) 127.8  (12.55) 126.2  (15.82)
Day 15: SBP-before infusion; n=78,78,74 127.6  (18.71) 125.5  (16.42) 129.2  (17.80)
Day 15: SBP- 1hour after infusion; n=72,75,71 126.9  (14.79) 125.9  (16.35) 128.2  (14.65)
Day 15: SBP-2.5 hours after infusion; n=80,78,78 130.1  (14.99) 124.9  (15.08) 131.2  (15.58)
Day 29: SBP-before infusion; n=77,79,75 125.6  (13.52) 126.2  (15.31) 126.9  (14.79)
Day 29: SBP-1hour after infusion; n=72,75,74 126.2  (12.92) 125.9  (15.85) 128.6  (15.34)
Day 29: SBP-2.5 hours after infusion; n=80,79,82 126.3  (13.77) 126.4  (14.86) 127.6  (14.54)
Day 57: SBP-before infusion; n=74,76,70 126.4  (15.47) 124.8  (16.21) 123.0  (13.21)
Day 57: SBP-1hour after infusion; n=74,69,68 124.6  (13.40) 122.1  (16.73) 124.4  (11.22)
Day 57: SBP-2.5 hours after infusion; n=81,73,73 127.0  (13.04) 123.6  (14.43) 126.1  (14.29)
Day 85: SBP- before infusion; n=73,71,67 122.0  (13.52) 118.7  (12.85) 122.2  (13.67)
Day 85: SBP-1hour after infusion; n=73,69,72 121.8  (13.28) 119.6  (13.59) 122.0  (14.23)
Day 113: SBP-before infusion; n=72,70,70 122.6  (18.07) 121.7  (14.26) 119.9  (14.16)
Day 113: SBP-1hour after infusion; n=75,70,75 121.5  (16.81) 121.0  (13.13) 120.1  (14.69)
Day 141: SBP-before infusion; n=66,70,66 121.4  (15.94) 119.2  (15.67) 118.8  (14.26)
Day 141: SBP-1hour after infusion; n=72,71,70 120.9  (18.11) 117.9  (15.32) 120.4  (13.26)
Day 169: SBP-before infusion; n=70,70,66 118.5  (16.30) 117.6  (12.13) 118.6  (14.65)
Day 169: SBP-1hour after infusion; n=75,71,71 120.3  (18.74) 118.2  (11.83) 118.9  (14.15)
Day 197: SBP-before infusion; n=68,70,64 119.0  (15.58) 118.9  (14.72) 118.7  (12.34)
Day 197: SBP-1hour after infusion; n=72,73,70 117.7  (14.76) 117.4  (13.10) 120.4  (15.29)
Day 225: SBP-before infusion; n=70,64,63 118.2  (14.53) 118.8  (13.51) 119.5  (13.20)
Day 225: SBP-1hour after infusion; n=72,65,68 116.6  (15.82) 119.5  (14.60) 118.8  (12.83)
Day 253: SBP-before infusion; n=63,66,63 120.6  (15.13) 120.2  (17.21) 120.9  (14.17)
Day 253: SBP-1hour after infusion; n=69,67,67 118.1  (14.81) 117.1  (15.02) 119.7  (14.16)
Day 281: SBP-before infusion; n=63,66,58 120.7  (14.02) 116.5  (14.30) 120.3  (12.78)
Day 281: SBP-1hour after infusion; n=66,65,64 119.5  (15.28) 119.4  (13.70) 121.0  (12.48)
Day 309: SBP-before infusion; n=63,63,59 119.4  (14.18) 116.3  (14.33) 120.5  (15.32)
Day 309: SBP-1hour after infusion; n=67,66,64 119.6  (13.47) 114.1  (14.97) 119.2  (15.73)
Day 337: SBP-before infusion; n=63,64,61 119.9  (12.52) 117.3  (14.71) 119.3  (14.49)
Day 337: SBP-1hour after infusion; n=68,65,67 120.4  (12.97) 117.7  (16.48) 119.3  (13.67)
27.Secondary Outcome
Title Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)
Hide Description [Not Specified]
Time Frame 0 - 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 98 99
Mean (Standard Deviation)
Unit of Measure: mm Hg
Day 1: DBP-before infusion; n=76,81,73 80.8  (11.69) 80.6  (12.57) 80.4  (12.40)
Day 1: DBP-1hour after infusion; n=69,78,70 79.6  (13.57) 79.6  (12.59) 80.1  (13.34)
Day 1: DBP-2.5 hours after infusion; n=79,81,76 79.3  (12.73) 79.0  (10.93) 80.9  (11.24)
Day 15: DBP-before infusion; n=78,78,74 81.1  (12.56) 80.0  (12.89) 82.6  (12.89)
Day 15: DBP- 1hour after infusion; n=72,75,71 79.6  (10.87) 78.7  (11.58) 80.4  (10.96)
Day 15: DBP-2.5 hours after infusion; n=80,78,78 81.4  (11.79) 78.0  (11.27) 82.8  (11.38)
Day 29: DBP-before infusion; n=77,79,75 79.6  (11.08) 78.8  (12.14) 81.3  (9.95)
Day 29: DBP-1hour after infusion; n=72,75,74 79.9  (10.06) 78.0  (12.84) 80.8  (10.36)
Day 29: DBP-2.5 hours after infusion; n=80,79,82 78.5  (9.75) 78.2  (11.62) 79.5  (11.08)
Day 57: DBP-before infusion; n=74,76,70 80.0  (10.98) 78.7  (10.69) 78.7  (10.59)
Day 57: DBP-1hour after infusion; n=74,69,68 78.9  (11.23) 75.3  (11.87) 78.7  (9.25)
Day 57: DBP-2.5 hours after infusion; n=81,73,73 79.5  (10.06) 76.1  (10.49) 80.2  (9.60)
Day 85: DBP- before infusion; n=73,71,67 79.7  (11.01) 75.2  (9.39) 78.7  (9.94)
Day 85: DBP-1hour after infusion; n=73,69,72 78.1  (11.72) 75.6  (9.29) 78.1  (10.58)
Day 113: DBP-before infusion; n=72,70,70 78.5  (13.75) 77.0  (10.58) 76.7  (11.62)
Day 113: DBP-1hour after infusion; n=75,70,75 76.1  (12.13) 76.3  (10.74) 76.9  (11.61)
Day 141: DBP-before infusion; n=66,70,66 78.8  (11.32) 74.0  (12.08) 76.5  (11.48)
Day 141: DBP-1hour after infusion; n=72,71,70 77.8  (11.24) 74.7  (11.54) 76.1  (11.69)
Day 169: DBP-before infusion; n=70,70,66 75.5  (12.96) 74.1  (10.18) 77.0  (13.16)
Day 169: DBP-1hour after infusion; n=75,71,71 76.5  (13.24) 74.4  (9.41) 76.4  (12.81)
Day 197: DBP-before infusion; n=68,70,64 76.8  (11.29) 75.8  (10.79) 75.8  (11.16)
Day 197: DBP-1hour after infusion; n=72,73,70 76.1  (11.63) 74.5  (10.55) 75.4  (12.21)
Day 225: DBP-before infusion; n=70,64,63 74.5  (12.39) 73.6  (9.68) 75.7  (10.77)
Day 225: DBP-1hour after infusion; n=72,65,68 75.0  (11.67) 74.5  (10.95) 76.0  (10.28)
Day 253: DBP-before infusion; n=63,66,63 76.1  (11.54) 75.9  (11.27) 77.1  (10.26)
Day 253: DBP-1hour after infusion; n=69,67,67 74.5  (11.51) 74.9  (10.25) 75.7  (10.20)
Day 281: DBP-before infusion; n=63,66,58 77.6  (10.89) 73.3  (9.50) 76.6  (9.31)
Day 281: DBP-1hour after infusion; n=66,65,64 75.9  (10.49) 74.5  (9.73) 76.6  (10.15)
Day 309: DBP-before infusion; n=63,63,59 78.1  (9.73) 72.9  (8.90) 77.4  (11.83)
Day 309: DBP-1hour after infusion; n=67,66,64 76.4  (10.81) 72.9  (9.86) 76.6  (10.75)
Day 337: DBP-before infusion; n=63,64,61 78.0  (10.54) 73.4  (9.52) 76.2  (10.65)
Day 337: DBP-1hour after infusion; n=68,65,67 78.1  (9.72) 73.3  (9.82) 76.1  (11.19)
28.Secondary Outcome
Title Vital Signs Summary During the Short-term Period: Heart Rate
Hide Description [Not Specified]
Time Frame 0 - 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: beats per minute
Day 1: before infusion; n=99,98,100 82.4  (11.17) 79.2  (10.84) 82.6  (12.11)
Day 1: 1hour after infusion; n=98,98,98 81.3  (11.08) 79.6  (9.71) 81.9  (10.64)
Day 1: 2.5 hours after infusion; n=97,96,96 81.8  (11.38) 82.2  (11.25) 83.8  (11.51)
Day 15: before infusion; n=97,93,99 83.1  (12.08) 81.0  (11.31) 83.7  (12.84)
Day 15: 1hour after infusion; n=96,94,98 81.3  (12.21) 80.1  (11.31) 82.6  (11.70)
Day 15: 2.5 hours after infusion; n=93,92,95 81.5  (11.18) 81.7  (9.88) 84.7  (12.65)
Day 29: before infusion; n=94,93,99 83.7  (12.13) 80.8  (11.85) 83.0  (12.91)
Day 29: 1hour after infusion; n=93,92,99 81.7  (12.23) 79.9  (9.60) 81.7  (11.00)
Day 29: 2.5 hours after infusion; n=92,90,97 81.3  (10.26) 82.1  (9.56) 84.7  (11.41)
Day 57: before infusion; n=93,88,84 83.4  (11.04) 82.2  (12.09) 82.8  (13.00)
Day 57: 1hour after infusion; n=93,84,94 81.0  (10.02) 81.6  (10.52) 81.8  (10.80)
Day 57: 2.5 hours after infusion; n=91,84,91 82.5  (10.13) 83.4  (12.20) 83.8  (11.09)
Day 85: before infusion; n=89,86,91 84.8  (12.35) 82.3  (11.00) 82.5  (10.99)
Day 85: 1hour after infusion; n=88,84,89 83.3  (11.02) 80.4  (10.67) 83.5  (9.50)
Day 113: before infusion; n=88,82,92 82.1  (11.46) 80.4  (11.88) 83.0  (11.78)
Day 113: 1hour after infusion; n=87,80,91 81.8  (10.64) 80.2  (9.98) 82.6  (10.62)
Day 141: before infusion; n=84,82,89 82.8  (11.75) 79.3  (11.20) 82.6  (12.74)
Day 141: 1hour after infusion; n=84,81,86 81.4  (10.92) 79.1  (10.59) 81.3  (11.30)
Day 169: before infusion; n=85,82,86 80.1  (10.01) 78.0  (11.35) 79.1  (10.95)
Day 169: 1hour after infusion; n=84,82,85 79.5  (10.43) 78.8  (10.97) 81.4  (12.30)
Day 197: before infusion; n=83,82,84 81.7  (10.54) 78.1  (10.72) 79.3  (11.58)
Day 197: 1hour after infusion; n=82,82,85 79.8  (9.84) 78.7  (10.25) 79.6  (11.77)
Day 225: before infusion; n=83,76,81 80.1  (10.04) 77.6  (10.59) 78.9  (10.00)
Day 225: 1hour after infusion; n=83,76,81 79.1  (9.86) 78.0  (9.83) 80.2  (10.03)
Day 253: before infusion; n=78,77,81 81.4  (11.32) 79.1  (11.30) 81.5  (12.17)
Day 253: 1hour after infusion; n=78,77,81 78.8  (9.01) 79.3  (10.64) 79.5  (10.91)
Day 281: before infusion; n=75,76,77 80.1  (10.56) 78.3  (11.16) 79.3  (10.24)
Day 281: 1hour after infusion; n=74,76,76 78.0  (9.93) 77.6  (9.46) 78.7  (9.95)
Day 309: before infusion; n=76,75,77 79.8  (10.89) 76.5  (10.07) 78.2  (10.66)
Day 309: 1hour after infusion; n=76,74,77 77.9  (10.40) 77.4  (9.81) 78.4  (11.49)
Day 337: before infusion; n=73,75,80 78.5  (11.77) 76.4  (9.95) 78.9  (11.50)
Day 337: 1hour after infusion; n=73,73,79 77.6  (9.85) 77.4  (9.73) 78.3  (11.11)
29.Secondary Outcome
Title Vital Signs Summary During the Short-term Period: Temperature
Hide Description [Not Specified]
Time Frame 0 - 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of double-blind study medication were included in the safety population. n= number of participants with a measurement at the select time point.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: degree celcius
Day 1: before infusion; n=99,98,99 36.6  (0.48) 36.5  (0.42) 36.5  (0.47)
Day 1: 1hour after infusion; n=98,96,97 36.6  (0.50) 36.5  (0.46) 36.6  (0.51)
Day 1: 2.5 hours after infusion; n=97,93,97 36.6  (0.45) 36.5  (0.43) 36.6  (0.49)
Day 15: before infusion; n=97,94,99 36.5  (0.50) 36.5  (0.45) 36.5  (0.47)
Day 15: 1hour after infusion; n=96,91,98 36.6  (0.47) 36.5  (0.45) 36.5  (0.53)
Day 15: 2.5 hours after infusion; n=93,91,95 36.6  (0.47) 36.5  (0.44) 36.6  (0.53)
Day 29: before infusion; n=94,93,99 36.5  (0.51) 36.4  (0.489) 36.5  (0.48)
Day 29: 1hour after infusion; n=93,91,98 36.5  (0.50) 36.5  (0.44) 36.5  (0.49)
Day 29: 2.5 hours after infusion; n=92,90,97 36.5  (0.46) 36.5  (0.47) 36.5  (0.49)
Day 57: before infusion; n=93,88,93 36.5  (0.46) 36.4  (0.50) 36.5  (0.49)
Day 57: 1hour after infusion; n=93,83,94 36.1  (3.58) 36.4  (0.46) 36.6  (0.49)
Day 57: 2.5 hours after infusion; n=90,84,90 36.5  (0.41) 36.5  (0.48) 36.5  (0.53)
Day 85: before infusion; n=89,86,91 36.4  (0.52) 36.4  (0.45) 36.5  (0.45)
Day 85: 1hour after infusion; n=87,84,89 36.4  (0.51) 36.4  (0.50) 36.5  (0.49)
Day 113: before infusion; n=88,82,92 36.5  (0.60) 36.4  (0.50) 36.5  (0.54)
Day 113: 1hour after infusion; n=87,79,91 36.4  (0.49) 36.4  (0.44) 36.5  (0.51)
Day 141: before infusion; n=84,81,89 36.5  (0.50) 36.4  (0.45) 36.5  (0.47)
Day 141: 1hour after infusion; n=84,80,86 36.5  (0.45) 36.4  (0.41) 36.5  (0.49)
Day 169: before infusion; n=85,81,86 36.5  (0.52) 36.4  (0.48) 36.5  (0.46)
Day 169: 1hour after infusion; n=84,80,84 36.4  (0.47) 36.4  (0.44) 36.5  (0.46)
Day 197: before infusion; n=83,82,85 36.5  (0.58) 36.3  (0.45) 36.5  (0.45)
Day 197: 1hour after infusion; n=82,81,84 36.4  (0.61) 36.3  (0.49) 36.5  (0.48)
Day 225: before infusion; n=83,76,81 36.5  (0.56) 36.4  (0.48) 36.4  (0.55)
Day 225: 1hour after infusion; n=83,75,81 36.5  (0.56) 36.4  (0.45) 36.5  (0.54)
Day 253: before infusion; n=78,77,80 36.5  (0.52) 36.4  (0.44) 36.5  (0.46)
Day 253: 1hour after infusion; n=78,77,81 36.5  (0.54) 36.4  (0.42) 36.5  (0.49)
Day 281: before infusion; n=75,76,77 36.5  (0.49) 36.4  (0.43) 36.5  (0.49)
Day 281: 1hour after infusion; n=74,76,76 36.5  (0.51) 36.4  (0.46) 36.5  (0.47)
Day 309: before infusion; n=76,75,77 36.5  (0.49) 36.3  (0.51) 36.5  (0.54)
Day 309: 1hour after infusion; n=75,73,77 36.5  (0.51) 36.4  (0.43) 36.5  (0.54)
Day 337: before infusion; n=73,75,79 36.5  (0.47) 36.4  (0.46) 36.5  (0.50)
Day 337: 1hour after infusion; n=73,72,79 36.5  (0.59) 36.4  (0.49) 36.5  (0.52)
30.Secondary Outcome
Title Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period
Hide Description A validated, sensitive electrochemiluminescence (ECL) immunoassay based on Meso-Scale Discovery instrumentation was used to evaluate immunogenicity. The ECL assay differentiated between two antibody specificities: (1) the ‘Ig and/or Junction (Jn) Region’ and (2) ‘CLTA4 and possibly Ig’. A sample was considered positive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept with or without CTLA4-T.
Time Frame Day 169, Day 365
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Hide Analysis Population Description
Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available. n= number of participants who are evaluated
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 95 96 0
Measure Type: Number
Unit of Measure: Participants
CTLA4 and possibly Ig; Day 169 (n=90) 2 1
CTLA4 and possibly Ig; Day 365 (n=74) 1 0
CTLA4 and possibly Ig;Overall on TRT visits (n=90) 3 1
CTLA4 and possibly Ig; Overall Post visits (n=20) 7 5
CTLA4 and possibly Ig; Overall (n=96) 9 6
Ig/Jn region; Day 169 (n=90) 0 0
Ig/Jn region; Day 365 (n=78) 1 0
Ig/Jn region; Overall on TRT visits (n=90) 1 0
Ig/Jn region; Overall on Post visits (n=20) 0 1
Ig/Jn region; Overall (n=95) 1 1
31.Secondary Outcome
Title Baseline Quantitative Immunoglobulins During the Short-term Period
Hide Description A quantitative immunoglobulins (Igs) test is used to detect abnormal levels of the three major classes of Igs (IgG, IgA, and IgM). Abnormal test results typically indicate that there is something affecting the immune system which requires further testing.
Time Frame Baseline (Day 1)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Error)
Unit of Measure: mg/dL
Immunoglobulin IgA 246.28  (99.55) 218.04  (88.23) 230.23  (107.34)
Immunoglobulin IgG 939.80  (423.66) 864.12  (459.44) 1013.17  (516.24)
Immunoglobulin IgM 100.96  (79.70) 97.10  (55.18) 98.49  (57.71)
32.Secondary Outcome
Title Change in Quantitative Immunoglobulin From Baseline During Short-term Period
Hide Description

A quantitative immunoglobulin (Ig) test is used to detect abnormal levels of the 3 major classes of Ig (IgG, IgA, and IgM). Abnormal test results typically indicate that something is affecting the immune system and further testing is required.

Please refer to Outcome 31 for the respective baseline values

Time Frame Day 365
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Hide Analysis Population Description
All randomized participants who received treatment. n=Participants with both postbaseline and baseline measurements
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Mean (Standard Deviation)
Unit of Measure: mg/dL
Ig A (n=76, 73, 78) -32.83  (8.47) -34.48  (6.87) -26.51  (8.20)
IgG (n=76, 73, 78) 41.41  (47.17) 27.21  (43.84) 23.42  (49.07)
IgM (n=76, 73, 78) -17.76  (5.28) -19.38  (4.76) -20.62  (4.89)
33.Secondary Outcome
Title Number of Participants Achieving Complete Response by ACCESS Definition
Hide Description The Abatacept and Cyclophosphamide Combination Efficacy and Safety Study (ACCESS) defines complete response as a response meeting all of the following criteria: serum creatinine ≤upper limit of normal as defined by the central laboratory or ≤125% of the higher value at either screening or baseline; urine protein/creatinine ratio <50 mg/mmoL; and prednisone or prednisone-equivalent dose tapered to 10 mg per day.
Time Frame End of short-term period (Day 365) to termination of the long-term extension period
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Hide Analysis Population Description
All participants who entered and received at least 1 dose of study medication during the long-term extension period
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 69 66 74
Measure Type: Number
Unit of Measure: participants
Day 365 29 30 25
Day 645 (n=55, 56, 61) 27 28 25
34.Secondary Outcome
Title Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis
Hide Description Patient response=complete, partial, or no response. Complete response=serum creatinine (SCr) normal, inactive urinary sediment, no cellular casts, urinary protein/creatinine (UPCR) ratio<56.5 mg/mmol. Partial response=SCr normal or ≤25% above baseline value, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the baseline ratio. No response=Not achieving complete or partial response criteria.
Time Frame At Day 365 (end of Short-term Period) and Day 645
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Hide Analysis Population Description
All participants who entered and received at least 1 dose of study medication during the long-term extension period
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) Short-term period: by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 69 66 74
Measure Type: Number
Unit of Measure: Participants
Day 365 43 39 42
Day 645 (n=59, 59, and 62) 45 29 36
35.Secondary Outcome
Title Mean Change From Baseline in SLICC/ACR Damage Index
Hide Description SLICC=Systemic Lupus International Collaborating Clinics; ACR=American College of Rheumatology. The SLICC/ACR Damage Index measures organ damage (nonreversible change, unrelated to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months unless otherwise stated. The index assesses 47 items in 12 systems: Ocular, Neuropsychiatric, Renal, Pulmonary, Cardiovascular, Gastrointestinal, Peripheral Vascular, Musculoskeletal, Skin, Premature Gonadal Failure, Diabetes, Malignancy. Scores range from 0 to 2, and the same lesion cannot be scored twice. If damage is noted for a particular item, it is scored 1. No damage is scored 0. Some items may score 2 points if they occur more than once, so that the maximum possible score is 47. Scores can only increase with time, but scores rarely reach over 12. It is usually completed (or updated) yearly.
Time Frame Day 365 to termination of the long-term extension phase
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All randomized participants who received treatment. Treated participants with both post-baseline and baseline measurements showing non-reversible changes in the SLICC/ACR Damage Index (i.e, Change from baseline greater than or equal to 0). 99, 99 and 100 participants were treated respectively. Refer to outcome measure 11 for baseline values
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Short-term period: Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 70 67 74
Mean (Standard Error)
Unit of Measure: Units on a scale
Day 365 (n=69, 65, 74) -0.12  (0.06) -0.17  (0.09) -0.08  (0.07)
Day 729 (n=66, 65, 69) -0.21  (0.10) -0.28  (0.09) -0.10  (0.08)
Day 1093 (n=41, 38, 44) -.27  (0.13) -0.16  (0.10) 0.02  (0.08)
36.Secondary Outcome
Title Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period
Hide Description AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug.
Time Frame From start of study drug in long-term period (Day 365) to up to 56 days after the last dose of the long-term extension (LTE). Deaths in LTE reported to >56 days post last dose.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered and received at least 1 dose of study medication during the long-term extension period
Arm/Group Title Abatacept 10 mg/kg
Hide Arm/Group Description:
Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: Participants
Deaths 5
SAEs 32
Treatment-related SAEs 14
Discontinuations due to SAEs 5
AEs 183
Treatment-related AEs 100
Discontinuations due to AEs 10
37.Secondary Outcome
Title Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period
Hide Description Collected in at least 1 sample. Assessment includes immunogenicity (detection of serum antibodies which bind to CTLA4-Ig in the in vitro assays) and exposure to corticosteroids
Time Frame Day 365 to end of long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available.
Arm/Group Title Abatacept 10 mg/kg
Hide Arm/Group Description:
Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 209
Measure Type: Number
Unit of Measure: Participants
17
38.Secondary Outcome
Title Number of Participants Achieving Renal Response
Hide Description Renal response=serum creatinine level ≤25% above baseline value and greater than or equal to 50% improvement in the urine protein/creatinine ratio with 1 of the following: urine protein/creatinine ratio (UPCR) <113 mg/mmol, if the baseline ratio was <= 339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio >339 mg/mmol.
Time Frame At Day 365 (end of short-term period) and Day 645
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 9 66 74
Measure Type: Number
Unit of Measure: participants
Day 365 46 66 74
Day 645 (n=59, 59, 62) 47 59 62
39.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period
Hide Description preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Hemoglobin (g/dL): >3g/dL decrease from preRX value. Hematocrit(%): <0.75*preRX. Erythrocytes (*10^6 c/uL): <0.75*preRX. Platelet count (*10^9 c/L): <0.67*LLN, or >1.5*ULN, or if preRX <LLN, use <0.5*preRX and <100,000/mm^3. Leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8* preRX or >ULN; if preRX>ULN, use >1.2*preRX or <LLN. Neutrophils + Bands (absolute) (*10^3 c/uL): If value <1.0*10^3 or if value >7.50*10^3 c/uL. Monocytes (absolute) (*10^3 c/uL): If value >2000/mm^3. Basophils (absolute)(*10^3 c/uL): If value >.750*10^3 c/uL. Eosinophils (absolute) (*10^3 c/uL): If value >.750*10^3 c/uL. ALP (U/L): >2*ULN, or if preRX>ULN, use >3* preRX. AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. GGT (U/L):>2*ULN, or if preRX >ULN, use >3*preRX. Bilirubin, total (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX. BUN (mg/dL): >1.5*preRX.
Time Frame From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered and received at least 1 dose of study medication during the long-term extension period
Arm/Group Title Abatacept 10 mg/kg
Hide Arm/Group Description:
Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: Participants
Hemoglobin (low) 13
Hemoglobin (high) NA [1] 
Hematocrit (n=210) (low) 11
Hematocrit (n=210) (high) NA [1] 
Erythrocytes (low) 10
Erythrocytes (high) NA [1] 
Platelet count (n=210) (low) 1
Platelet count (n=210) (high) 0
Leukocytes (low) 40
Leukocytes (high) 9
Neutrophils + Bands (absolute) (low) 4
Neutrophils + Bands (absolute) (high) NA [1] 
Lymphocytes (absolute) (low) 59
Lymphocytes (absolute) (high) 0
Monocytes (absolute) (low) NA [1] 
Monocytes (absolute) (high) 0
Basophils (absolute) (low) NA [1] 
Basophils (absolute) (high) 0
Eosinophils (absolute) (low) NA [1] 
Eosinophils (absolute) (high) 8
Alkaline phosphatase (ALP) (low) NA [1] 
ALP (high) 3
Aspartate aminotransferase (AST) (low) NA [1] 
AST (high) 3
Alanine aminotransferase (ALT) (low) NA [1] 
ALT (high) 5
G-glutamyl transferase (GGT) (low) NA [1] 
GGT (high) 14
Bilirubin, total (low) NA [1] 
Bilirubin, total (high) 0
Blood urea nitrogen (BUN) (low) NA [1] 
BUN (high) 9
Creatinine (low) NA [1] 
Creatinine (high) 16
[1]
Not evaluated
40.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
Hide Description LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX<LLN, use <0.95*preRX or >ULN if preRX>ULN, use >1.05*preRX or <LLN. Potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN. Chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRX<LLN, use <0.75*preRX or >ULN if preRX>ULN, use >1.25*preRX or <LLN. Glucose, serum (mg/dL): <65 mg/dL, or >220 mg/dL. Glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRX <LLN, use <0.8*preRX or >ULN if preRX>ULN, use >2.0*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX <LLN, use <0.75*preRX. Cholesterol, total (mg/dL): >2*preRX. Triglycerides (mg/dL): >=2.5*ULN, or if preRX>ULN, use >=2.5*preRX. Triglycerides, fasting (mg/dL): >=2*ULN, or if preRX>ULN, use >2.0*preRX.
Time Frame From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered and received at least 1 dose of study medication during the long-term extension period
Arm/Group Title Abatacept 10 mg/kg
Hide Arm/Group Description:
Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: Participants
Sodium, serum (low) 1
Sodium, serum (high) 2
Potassium, serum (n=210) (low) 11
Potassium, serum (n=210) (high) 3
Chloride, serum (low) 0
Chloride, serum (high) 0
Calcium, total (n=210) (low) 1
Calcium, total (n=210) (high) 2
Glucose, serum (low) 23
Glucose, serum (high) 2
Glucose, fasting serum (low) (n=143) 2
Glucose, fasting serum (high) (n=143) 2
Protein, total (low) 19
Protein, total (high) 0
Albumin (low) 12
Albumin (high) NA [1] 
Cholesterol, total (low) (n=32) 32
Cholesterol, total (high) (n=32) NA [1] 
Triglycerides (low) (n=20) 20
Triglycerides (high) (n=20) NA [1] 
Triglycerides, fasting (low) (n=18) 18
Triglycerides, fasting (high) (n=18) NA [1] 
Protein, urine (low) NA [1] 
Protein, urine (high) 9
Glucose, urine (low) NA [1] 
Glucose, urine (high) 1
Blood, urine (low) NA [1] 
Blood, urine (high) 35
Leukocyte esterase, urine (low) (n=185) NA [1] 
Leukocyte esterase, urine (high) (n=185) 27
[1]
Not evaluated
41.Secondary Outcome
Title Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
Hide Description preRX=pretreatment. Protein, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 OR 3 then use >=4. Glucose, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Blood, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Leukocyte esterase, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4.
Time Frame From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered and received at least 1 dose of study medication during the long-term extension period
Arm/Group Title Abatacept 10 mg/kg
Hide Arm/Group Description:
Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: Participants
Protein, urine (low) NA [1] 
Protein, urine (high) 9
Glucose, urine (low) NA [1] 
Glucose, urine (high) 1
Blood, urine (low) NA [1] 
Blood, urine (high) 35
Leukocyte esterase, urine (low) (n=185) NA [1] 
Leukocyte esterase, urine (high) (n=185) 27
[1]
Not evaluable
42.Other Pre-specified Outcome
Title Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period
Hide Description

PR is either CRR, Partial Renal Response(PRR),or no Response(NR).

CRR= Serum creatinine(SC)is normal, Inactive urinary sediment, No cellular casts, Urinary protein/creatinine (UPCR) ratio <56.5 mg/mmoL; PRR= SC is normal OR SC not >25% above BL, RBCs at reference range, UPCR <56.5 mg/mmoL OR ≥50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the BL ratio; NR= Not achieving either a CRR or a PRR. Participants achieved response if criteria at both months 11 and 12 (Days 337 and 365) were met. Participants who Early discontinuations were categorized as NR.

Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received treatment.
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description:
Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
Overall Number of Participants Analyzed 99 99 100
Measure Type: Number
Unit of Measure: Participants
No Renal Response 61 69 66
Partial Renal Response 14 9 14
Complete Renal Response 24 21 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept 30/10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.68 to 21.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Abatacept 10/10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.49 to 1.59
Estimation Comments [Not Specified]
Time Frame Day 1 of Double-blind Period to within 56 days after last infusion of Double-blind Period or first infusion of Open-label Period, whichever occurred first.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Hide Arm/Group Description Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: In the double-blind period, participants received abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57. In the open-label period, participants received abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Abatacept 10/10 mg/kg regimen by IV infusion: Participants received abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent. Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
All-Cause Mortality
Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/99 (33.33%)   28/99 (28.28%)   31/100 (31.00%) 
Blood and lymphatic system disorders       
THROMBOCYTOPENIA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
THROMBOTIC MICROANGIOPATHY  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
PANCYTOPENIA  1  0/99 (0.00%)  1/99 (1.01%)  1/100 (1.00%) 
LYMPHOCYTOSIS  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
ANAEMIA  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
HAEMOLYTIC URAEMIC SYNDROME  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Cardiac disorders       
MYOCARDITIS  1  2/99 (2.02%)  0/99 (0.00%)  0/100 (0.00%) 
ATRIOVENTRICULAR BLOCK SECOND DEGREE  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
CARDIAC FAILURE  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
CARDIAC FAILURE CONGESTIVE  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
CORONARY ARTERY DISEASE  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Ear and labyrinth disorders       
VERTIGO  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
Eye disorders       
DIPLOPIA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
Gastrointestinal disorders       
VASCULITIS GASTROINTESTINAL  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
DIARRHOEA  1  0/99 (0.00%)  1/99 (1.01%)  1/100 (1.00%) 
ABDOMINAL PAIN  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
ASCITES  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
GASTRIC ULCER  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
General disorders       
PYREXIA  1  1/99 (1.01%)  0/99 (0.00%)  2/100 (2.00%) 
INFUSION RELATED REACTION  1  1/99 (1.01%)  0/99 (0.00%)  1/100 (1.00%) 
MULTI-ORGAN FAILURE  1  1/99 (1.01%)  0/99 (0.00%)  1/100 (1.00%) 
GENERALISED OEDEMA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
DRUG INEFFECTIVE  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
Hepatobiliary disorders       
GALLBLADDER POLYP  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Immune system disorders       
HYPERSENSITIVITY  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
Infections and infestations       
GASTROENTERITIS  1  5/99 (5.05%)  1/99 (1.01%)  2/100 (2.00%) 
PNEUMONIA  1  4/99 (4.04%)  4/99 (4.04%)  3/100 (3.00%) 
HERPES ZOSTER  1  3/99 (3.03%)  6/99 (6.06%)  0/100 (0.00%) 
CELLULITIS  1  1/99 (1.01%)  1/99 (1.01%)  0/100 (0.00%) 
SUBCUTANEOUS ABSCESS  1  1/99 (1.01%)  1/99 (1.01%)  0/100 (0.00%) 
CRYPTOCOCCOSIS  1  1/99 (1.01%)  0/99 (0.00%)  1/100 (1.00%) 
JOINT ABSCESS  1  1/99 (1.01%)  0/99 (0.00%)  1/100 (1.00%) 
LUNG INFECTION  1  1/99 (1.01%)  0/99 (0.00%)  1/100 (1.00%) 
DIARRHOEA INFECTIOUS  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
DISSEMINATED TUBERCULOSIS  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
LOCALISED INFECTION  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
PARONYCHIA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
PNEUMOCYSTIS JIROVECI PNEUMONIA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
PNEUMONIA BACTERIAL  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
PYELONEPHRITIS  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
TUBO-OVARIAN ABSCESS  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
UROSEPSIS  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
URINARY TRACT INFECTION  1  0/99 (0.00%)  2/99 (2.02%)  2/100 (2.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/99 (0.00%)  1/99 (1.01%)  2/100 (2.00%) 
LUNG ABSCESS  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
OSTEOMYELITIS  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
RESPIRATORY TRACT INFECTION  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
SEPTIC SHOCK  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
TUBERCULOSIS  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
BRONCHOPNEUMONIA  1  0/99 (0.00%)  0/99 (0.00%)  2/100 (2.00%) 
CANDIDIASIS  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
HISTOPLASMOSIS DISSEMINATED  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
MALARIA  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
MENINGITIS  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
OTITIS MEDIA  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
OTITIS MEDIA CHRONIC  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
PULMONARY TUBERCULOSIS  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
SEPSIS  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
VIRAL INFECTION  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Injury, poisoning and procedural complications       
JOINT DISLOCATION  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Investigations       
HAEMATOCRIT DECREASED  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
HAEMOGLOBIN DECREASED  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
Metabolism and nutrition disorders       
HYPERKALAEMIA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
HYPOALBUMINAEMIA  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Musculoskeletal and connective tissue disorders       
SYSTEMIC LUPUS ERYTHEMATOSUS  1  1/99 (1.01%)  2/99 (2.02%)  4/100 (4.00%) 
JOINT EFFUSION  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
CHONDRITIS  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
POLYARTHRITIS  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
KAPOSI'S SARCOMA  1  0/99 (0.00%)  1/99 (1.01%)  1/100 (1.00%) 
HAEMANGIOMA OF LIVER  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
HISTIOCYTOSIS HAEMATOPHAGIC  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Nervous system disorders       
PRESYNCOPE  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
CONVULSION  1  0/99 (0.00%)  2/99 (2.02%)  0/100 (0.00%) 
HEADACHE  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
EPILEPSY  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Psychiatric disorders       
DEPRESSION  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Renal and urinary disorders       
RENAL FAILURE  1  2/99 (2.02%)  1/99 (1.01%)  0/100 (0.00%) 
RENAL FAILURE ACUTE  1  1/99 (1.01%)  1/99 (1.01%)  2/100 (2.00%) 
LUPUS NEPHRITIS  1  1/99 (1.01%)  1/99 (1.01%)  0/100 (0.00%) 
NEPHRITIS  1  1/99 (1.01%)  0/99 (0.00%)  2/100 (2.00%) 
NEPHROTIC SYNDROME  1  1/99 (1.01%)  0/99 (0.00%)  1/100 (1.00%) 
RENAL IMPAIRMENT  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
GLOMERULONEPHRITIS CHRONIC  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
NEPHROLITHIASIS  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
GLOMERULONEPHRITIS  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
RENAL FAILURE CHRONIC  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Reproductive system and breast disorders       
SCROTAL OEDEMA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
OVARIAN CYST  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
RESPIRATORY FAILURE  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
INTERSTITIAL LUNG DISEASE  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
PNEUMONITIS  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
PULMONARY OEDEMA  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
PLEURAL EFFUSION  1  0/99 (0.00%)  0/99 (0.00%)  2/100 (2.00%) 
ACUTE RESPIRATORY DISTRESS SYNDROME  1  0/99 (0.00%)  0/99 (0.00%)  1/100 (1.00%) 
Skin and subcutaneous tissue disorders       
ANGIOEDEMA  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
Vascular disorders       
DEEP VEIN THROMBOSIS  1  1/99 (1.01%)  0/99 (0.00%)  0/100 (0.00%) 
HYPERTENSION  1  0/99 (0.00%)  1/99 (1.01%)  0/100 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version: 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept 30/10 mg/kg Abatacept 10/10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   83/99 (83.84%)   75/99 (75.76%)   84/99 (84.85%) 
Blood and lymphatic system disorders       
ANAEMIA  1  6/99 (6.06%)  8/99 (8.08%)  9/99 (9.09%) 
LEUKOPENIA  1  6/99 (6.06%)  1/99 (1.01%)  5/99 (5.05%) 
Eye disorders       
CONJUNCTIVITIS  1  0/99 (0.00%)  2/99 (2.02%)  8/99 (8.08%) 
Gastrointestinal disorders       
DIARRHOEA  1  13/99 (13.13%)  11/99 (11.11%)  19/99 (19.19%) 
NAUSEA  1  10/99 (10.10%)  8/99 (8.08%)  7/99 (7.07%) 
ABDOMINAL PAIN  1  5/99 (5.05%)  5/99 (5.05%)  6/99 (6.06%) 
VOMITING  1  5/99 (5.05%)  5/99 (5.05%)  8/99 (8.08%) 
MOUTH ULCERATION  1  4/99 (4.04%)  2/99 (2.02%)  5/99 (5.05%) 
ABDOMINAL PAIN UPPER  1  3/99 (3.03%)  6/99 (6.06%)  4/99 (4.04%) 
DYSPEPSIA  1  3/99 (3.03%)  5/99 (5.05%)  2/99 (2.02%) 
GASTRITIS  1  3/99 (3.03%)  3/99 (3.03%)  6/99 (6.06%) 
General disorders       
PYREXIA  1  13/99 (13.13%)  6/99 (6.06%)  5/99 (5.05%) 
OEDEMA PERIPHERAL  1  12/99 (12.12%)  9/99 (9.09%)  16/99 (16.16%) 
CHEST PAIN  1  6/99 (6.06%)  3/99 (3.03%)  3/99 (3.03%) 
ASTHENIA  1  5/99 (5.05%)  2/99 (2.02%)  4/99 (4.04%) 
FATIGUE  1  5/99 (5.05%)  4/99 (4.04%)  4/99 (4.04%) 
Infections and infestations       
UPPER RESPIRATORY TRACT INFECTION  1  30/99 (30.30%)  29/99 (29.29%)  32/99 (32.32%) 
GASTROENTERITIS  1  9/99 (9.09%)  7/99 (7.07%)  3/99 (3.03%) 
URINARY TRACT INFECTION  1  9/99 (9.09%)  10/99 (10.10%)  17/99 (17.17%) 
BRONCHITIS  1  7/99 (7.07%)  8/99 (8.08%)  11/99 (11.11%) 
NASOPHARYNGITIS  1  6/99 (6.06%)  11/99 (11.11%)  7/99 (7.07%) 
ORAL CANDIDIASIS  1  6/99 (6.06%)  2/99 (2.02%)  7/99 (7.07%) 
HERPES ZOSTER  1  5/99 (5.05%)  6/99 (6.06%)  2/99 (2.02%) 
ORAL HERPES  1  2/99 (2.02%)  6/99 (6.06%)  2/99 (2.02%) 
Metabolism and nutrition disorders       
HYPOKALAEMIA  1  2/99 (2.02%)  4/99 (4.04%)  6/99 (6.06%) 
HYPERCHOLESTEROLAEMIA  1  1/99 (1.01%)  4/99 (4.04%)  6/99 (6.06%) 
Musculoskeletal and connective tissue disorders       
BACK PAIN  1  12/99 (12.12%)  7/99 (7.07%)  8/99 (8.08%) 
ARTHRALGIA  1  9/99 (9.09%)  7/99 (7.07%)  17/99 (17.17%) 
PAIN IN EXTREMITY  1  6/99 (6.06%)  1/99 (1.01%)  3/99 (3.03%) 
MUSCLE SPASMS  1  5/99 (5.05%)  5/99 (5.05%)  8/99 (8.08%) 
MUSCULOSKELETAL PAIN  1  2/99 (2.02%)  2/99 (2.02%)  5/99 (5.05%) 
MYALGIA  1  1/99 (1.01%)  2/99 (2.02%)  6/99 (6.06%) 
Nervous system disorders       
HEADACHE  1  21/99 (21.21%)  11/99 (11.11%)  15/99 (15.15%) 
DIZZINESS  1  7/99 (7.07%)  5/99 (5.05%)  4/99 (4.04%) 
Psychiatric disorders       
INSOMNIA  1  5/99 (5.05%)  6/99 (6.06%)  9/99 (9.09%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  8/99 (8.08%)  6/99 (6.06%)  15/99 (15.15%) 
OROPHARYNGEAL PAIN  1  5/99 (5.05%)  3/99 (3.03%)  3/99 (3.03%) 
Skin and subcutaneous tissue disorders       
ACNE  1  8/99 (8.08%)  7/99 (7.07%)  4/99 (4.04%) 
ALOPECIA  1  4/99 (4.04%)  4/99 (4.04%)  7/99 (7.07%) 
Vascular disorders       
HYPERTENSION  1  9/99 (9.09%)  9/99 (9.09%)  7/99 (7.07%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version: 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
Results Point of Contact
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00430677     History of Changes
Other Study ID Numbers: IM101-075
First Submitted: February 1, 2007
First Posted: February 2, 2007
Results First Submitted: February 13, 2012
Results First Posted: May 11, 2012
Last Update Posted: March 20, 2015