Trial Outcomes & Findings for Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis (NCT NCT00430677)

NCT ID: NCT00430677

Last Updated: 2015-03-20

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 423 participants
• Primary outcome timeframe: Day 1 (randomization) to 12 months.
• Results posted on: 2015-03-20

Participant Flow

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.

Participant milestones

Measure	Abatacept 30/10 mg/kg 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.	Abatacept 10/10 mg/kg 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.	Placebo 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.
Short-term Period STARTED	99	99	100
Short-term Period COMPLETED	76	74	78
Short-term Period NOT COMPLETED	23	25	22
Long-term Extension Period STARTED	70	67	74
Long-term Extension Period COMPLETED	10	9	11
Long-term Extension Period NOT COMPLETED	60	58	63

Reasons for withdrawal

Measure	Abatacept 30/10 mg/kg 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.	Abatacept 10/10 mg/kg 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.	Placebo 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.
Short-term Period Death	1	1	5
Short-term Period Adverse Event	15	13	9
Short-term Period Lack of Efficacy	5	6	4
Short-term Period Withdrawal by Subject	1	1	2
Short-term Period Participant no longer met study criteria	1	1	2
Short-term Period Poor compliance/ noncompliance	0	1	0
Short-term Period Pregnancy	0	2	0
Long-term Extension Period Death	1	0	0
Long-term Extension Period Adverse Event	3	2	5
Long-term Extension Period Lack of Efficacy	5	3	8
Long-term Extension Period Lost to Follow-up	1	1	1
Long-term Extension Period Withdrawal by Subject	5	1	2
Long-term Extension Period Pregnancy	1	1	0
Long-term Extension Period Administrative reason by sponsor	41	49	46
Long-term Extension Period Other	2	1	1
Long-term Extension Period Poor compliance/noncompliance	1	0	0

Baseline Characteristics

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Baseline characteristics by cohort

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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 n=298 Participants Total of all reporting groups
Age, Customized 16 - 29 years	55 Participants n=5 Participants	52 Participants n=7 Participants	46 Participants n=5 Participants	153 Participants n=4 Participants
Age, Customized 30 - 39 years	28 Participants n=5 Participants	30 Participants n=7 Participants	33 Participants n=5 Participants	91 Participants n=4 Participants
Age, Customized 40 - 49 years	10 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants	38 Participants n=4 Participants
Age, Customized 50 - 59 years	5 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Age, Customized >= 60 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	86 Participants n=7 Participants	81 Participants n=5 Participants	251 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	19 Participants n=5 Participants	47 Participants n=4 Participants
Race White	28 Participants n=5 Participants	45 Participants n=7 Participants	38 Participants n=5 Participants	111 Participants n=4 Participants
Race Black/African American	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race American Indian/Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race Native Hawaiian/Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race Other Asian	60 Participants n=5 Participants	49 Participants n=7 Participants	55 Participants n=5 Participants	164 Participants n=4 Participants
Race Other	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Weight, Group <60 kg	54 participants 0.68 • n=5 Participants	55 participants 0.62 • n=7 Participants	45 participants 0.73 • n=5 Participants	154 participants n=4 Participants
Weight, Group 60 - 100 kg	42 participants n=5 Participants	43 participants n=7 Participants	51 participants n=5 Participants	136 participants n=4 Participants
Weight, Group >100 kg	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	8 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 (randomization) to 12 months.

Population: All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period	NA days 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).	NA days 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).	NA days 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).

SECONDARY outcome

Timeframe: Day 1 to 12 months

Population: All randomized participants who received treatment. Participants who discontinued early without meeting the confirmed CRR criteria were imputed as nonresponders.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period	22 Participants	27 Participants	20 Participants

SECONDARY outcome

Timeframe: At Month 12 from Day 1

Population: All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period	9 Participants	11 Participants	8 Participants

SECONDARY outcome

Timeframe: Day 1 (randomization) to 12 months.

Population: All randomized participants who received treatment. Includes participants who died and who were censored at the time of discontinuation

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)	141 Days Interval 88.0 to 169.0	136 Days Interval 92.0 to 171.0	144 Days Interval 113.0 to 198.0

SECONDARY outcome

Timeframe: At Month 12 from Day 1

Population: All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period	38 Participants Interval 28.8 to 48.0	37 Participants Interval 27.8 to 46.9	31 Participants Interval 21.9 to 40.1

SECONDARY outcome

Timeframe: Day 1 (randomization) to 12 Months

Population: All randomized participants who received participants.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Number of Months CRR Was Maintained During Short-term Period	0 Months Full Range 1.5 • Interval 0.0 to 11.0	0 Months Full Range 1 • Interval 0.0 to 8.0	0 Months Full Range 1.1 • Interval 0.0 to 11.0

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 15 (n=98,94,98)	92.57 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.57	99.09 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.41	91.01 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 29.60
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 29 (n=98,95,98)	93.08 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.14	98.56 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.26	91.23 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 29.33
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 57 (n=94, 89, 96)	91.54 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.99	98.76 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.96	91.58 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 28.93
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 85 (n=90, 91, 93)	94.53 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.53	100.22 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.50	92.76 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 29.01
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 113 (n=91, 83, 91)	94.43 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.80	101.23 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.38	92.41 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 28.15
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 141 (n=89, 83, 90)	93.62 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.74	101.05 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.73	92.83 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 29.10
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 169 (n=83, 82, 85)	94.83 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.10	101.95 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.82	92.56 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 29.85
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 197 (n=84, 81, 87)	94.55 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.98	101.85 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.26	92.69 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 29.51
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 225 (n=84, 81, 84)	94.87 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 35.82	101.64 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.26	93.25 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 29.75
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 253 (n=81, 76, 81)	94.89 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.24	101.25 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.67	93.38 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 30.07
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 281 (n=78, 77, 80)	94.17 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.55	102.64 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.76	93.13 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 30.13
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 309 (n=77, 76, 78)	94.74 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 36.81	100.64 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 33.80	92.71 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 30.23
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 337 (n=74, 75, 79)	95.51 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 37.30	101.00 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 33.89	92.90 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 30.13
Baseline Renal Function Over Time During Short-term Period Baseline (Day 1) for Day 365 (n=75, 73, 78)	95.04 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 37.24	101.30 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 34.21	93.03 milliliters per minute (mL/min)/1.73 m^2 Standard Deviation 30.53

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365

Population: ITT population (all randomized and treated subjects). n= Number of participants with both baseline and post-baseline measurements for that time point.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Change in Renal Function From Baseline Over Time During Short-term Period Day 337 (n=74, 75, 79)	5.34 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.60	10.15 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.74	4.39 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.86
Change in Renal Function From Baseline Over Time During Short-term Period Day 253 (n=81, 76, 81)	4.70 milliliters per minute (mL/min)/1.73 m^2 Standard Error 3.02	7.22 milliliters per minute (mL/min)/1.73 m^2 Standard Error 3.50	5.86 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.39
Change in Renal Function From Baseline Over Time During Short-term Period Day 15; (n=98,94,98)	-0.24 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.08	1.15 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.11	0.62 milliliters per minute (mL/min)/1.73 m^2 Standard Error 1.41
Change in Renal Function From Baseline Over Time During Short-term Period Day 29 (n=98, 95, 98)	2.26 milliliters per minute (mL/min)/1.73 m^2 Standard Error 1.87	4.51 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.60	1.70 milliliters per minute (mL/min)/1.73 m^2 Standard Error 1.88
Change in Renal Function From Baseline Over Time During Short-term Period Day 57 (n=94 89 96)	5.96 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.13	7.28 milliliters per minute (mL/min)/1.73 m^2 Standard Error 3.38	2.38 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.27
Change in Renal Function From Baseline Over Time During Short-term Period Day 85 (n=90, 91, 93)	8.56 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.88	6.20 milliliters per minute (mL/min)/1.73 m^2 Standard Error 3.30	2.89 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.30
Change in Renal Function From Baseline Over Time During Short-term Period Day 113 (n=91, 83, 91)	5.31 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.73	10.23 milliliters per minute (mL/min)/1.73 m^2 Standard Error 4.11	4.12 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.70
Change in Renal Function From Baseline Over Time During Short-term Period Day 141 (n=89, 83, 90)	8.33 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.74	7.90 milliliters per minute (mL/min)/1.73 m^2 Standard Error 3.00	3.62 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.28
Change in Renal Function From Baseline Over Time During Short-term Period Day 169 (n=83, 82, 85)	8.12 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.70	10.55 milliliters per minute (mL/min)/1.73 m^2 Standard Error 3.46	7.34 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.31
Change in Renal Function From Baseline Over Time During Short-term Period Day 197 (n=84, 81, 87)	7.71 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.73	10.67 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.78	6.79 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.25
Change in Renal Function From Baseline Over Time During Short-term Period Day 225 (n=84, 81, 84)	7.32 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.78	7.72 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.77	7.19 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.23
Change in Renal Function From Baseline Over Time During Short-term Period Day 281 (n=78, 77, 80)	5.68 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.83	6.81 milliliters per minute (mL/min)/1.73 m^2 Standard Error 3.37	5.38 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.30
Change in Renal Function From Baseline Over Time During Short-term Period Day 309 (n=77, 76, 78)	6.34 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.89	9.53 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.95	6.00 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.57
Change in Renal Function From Baseline Over Time During Short-term Period Day 365 (n=75, 73, 78)	5.17 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.75	11.03 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.85	5.68 milliliters per minute (mL/min)/1.73 m^2 Standard Error 2.49

SECONDARY outcome

Timeframe: Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)

Population: 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).

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period Baseline (n=68, 67, 70)	0.34 Units on a scale Standard Deviation 0.68	0.27 Units on a scale Standard Deviation 0.62	0.29 Units on a scale Standard Deviation 0.73
Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period Post Baseline Mean (n=68, 67, 70)	0.53 Units on a scale Standard Deviation 1.04	0.40 Units on a scale Standard Deviation 0.80	0.44 Units on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Month 12

Population: All randomized participants who received treatment. Missing response values were imputed as nonresponders for participants who discontinued early after receiving study medication.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period	45 Participants Interval 35.6 to 55.3	39 Participants Interval 29.8 to 49.0	33 Participants Interval 23.8 to 42.2

SECONDARY outcome

Timeframe: Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)

Population: 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

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=68 Participants 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 n=67 Participants 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 n=70 Participants 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
Change in SLICC/ACR Damage Index From Baseline During Short-term Period	0.17 Units on a scale Standard Error 0.06	0.11 Units on a scale Standard Error 0.06	0.13 Units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period Baseline (Day 1) for Day 85 (n=89, 91, 93)	42.18 Units on a scale Standard Deviation 9.07	43.80 Units on a scale Standard Deviation 8.42	42.68 Units on a scale Standard Deviation 8.93
Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period Baseline (Day 1) for Day 169 (n=92, 94, 96)	42.04 Units on a scale Standard Deviation 9.08	44.17 Units on a scale Standard Deviation 8.55	42.48 Units on a scale Standard Deviation 8.90
Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period Baseline (Day 1) for Day 253 (n=92, 94, 96)	42.04 Units on a scale Standard Deviation 9.08	44.17 Units on a scale Standard Deviation 8.55	42.48 Units on a scale Standard Deviation 8.90
Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period Baseline (Day 1) for Day 365 (n=92, 94, 96)	42.04 Units on a scale Standard Deviation 9.08	44.17 Units on a scale Standard Deviation 8.55	42.48 Units on a scale Standard Deviation 8.90

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period Day 85 (n=89, 91, 93)	4.17 Units on a scale Standard Error 0.82	2.61 Units on a scale Standard Error 0.81	2.86 Units on a scale Standard Error 0.80
Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period Day 169 (n=92, 94, 96)	4.18 Units on a scale Standard Error 0.85	4.07 Units on a scale Standard Error 0.84	3.39 Units on a scale Standard Error 0.83
Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period Day 253 (n=92, 94, 96)	4.23 Units on a scale Standard Error 0.92	4.80 Units on a scale Standard Error 0.91	3.45 Units on a scale Standard Error 0.90
Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period Day 365 (n=92, 94, 96)	4.24 Units on a scale Standard Error 0.91	5.00 Units on a scale Standard Error 0.91	3.77 Units on a scale Standard Error 0.90

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Baseline Mental Component Summary of the Short SF-36 During Short-term Period Baseline (Day 1) for Day 85 ( n=89, 91, 93)	42.18 Units on a scale Standard Deviation 9.07	43.80 Units on a scale Standard Deviation 8.42	42.68 Units on a scale Standard Deviation 8.93
Baseline Mental Component Summary of the Short SF-36 During Short-term Period Baseline (Day 1) for Day 169 (n=92,94,96)	44.08 Units on a scale Standard Deviation 10.93	41.84 Units on a scale Standard Deviation 11.50	42.59 Units on a scale Standard Deviation 12.22
Baseline Mental Component Summary of the Short SF-36 During Short-term Period Baseline (Day 1) for Day 253 ( n=92,94,96)	44.08 Units on a scale Standard Deviation 10.93	41.84 Units on a scale Standard Deviation 11.50	42.59 Units on a scale Standard Deviation 12.22
Baseline Mental Component Summary of the Short SF-36 During Short-term Period Baseline (Day 1) for Day 365 ( n=92,94,96)	44.08 Units on a scale Standard Deviation 10.93	41.84 Units on a scale Standard Deviation 11.50	42.59 Units on a scale Standard Deviation 12.22

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period Day 85 (n=89, 91, 93)	1.07 Units on a scale Standard Error 1.11	3.10 Units on a scale Standard Error 1.08	1.87 Units on a scale Standard Error 1.08
Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period Day 169 (n=92, 94, 96)	2.90 Units on a scale Standard Error 1.01	5.08 Units on a scale Standard Error 1.00	3.69 Units on a scale Standard Error 0.99
Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period Day 253 (n=92, 94, 96)	2.45 Units on a scale Standard Error 1.00	4.83 Units on a scale Standard Error 0.99	2.99 Units on a scale Standard Error 0.98
Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period Day 365 (n=92, 94, 96)	2.62 Units on a scale Standard Error 0.96	4.23 Units on a scale Standard Error 0.95	2.84 Units on a scale Standard Error 0.94

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period Baseline (Day 1) for Day 85 (n=90, 94, 95)	48.86 Units on a scale Standard Deviation 25.97	41.95 Units on a scale Standard Deviation 22.81	48.93 Units on a scale Standard Deviation 25.47
Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period Baseline (Day 1) for Day 169 (n=92, 94, 97)	48.80 Units on a scale Standard Deviation 25.96	41.95 Units on a scale Standard Deviation 22.81	48.25 Units on a scale Standard Deviation 25.68
Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period Baseline (Day 1) for Day 253 (n=92, 94, 97)	48.80 Units on a scale Standard Deviation 25.96	41.95 Units on a scale Standard Deviation 22.81	48.25 Units on a scale Standard Deviation 25.68
Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period Baseline (Day 1) for Day 365 (n=92, 94, 97)	48.80 Units on a scale Standard Deviation 25.96	41.95 Units on a scale Standard Deviation 22.81	48.25 Units on a scale Standard Deviation 25.68

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period Day 85 (n=90, 94, 95)	-9.18 Units on a scale Standard Error 2.37	-4.94 Units on a scale Standard Error 2.33	-6.20 Units on a scale Standard Error 2.33
Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period Day 169 (n=92, 94, 97)	-7.18 Units on a scale Standard Error 2.49	-9.52 Units on a scale Standard Error 2.48	-4.71 Units on a scale Standard Error 2.44
Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period Day 253 (n=92, 94, 97)	-8.78 Units on a scale Standard Error 2.59	-11.90 Units on a scale Standard Error 2.57	-7.35 Units on a scale Standard Error 2.53
Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period Day 365 (n=92, 94, 97)	-12.21 Units on a scale Standard Error 2.70	-12.32 Units on a scale Standard Error 2.69	-11.07 Units on a scale Standard Error 2.65

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period Baseline (Day 1) for Day 85 (n=90, 94, 95)	40.60 Units on a scale Standard Deviation 13.75	39.14 Units on a scale Standard Deviation 13.54	39.64 Units on a scale Standard Deviation 13.00
Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period Baseline (Day 1) for Day 169 (n=92, 94, 97)	40.41 Units on a scale Standard Deviation 13.67	39.14 Units on a scale Standard Deviation 13.54	39.59 Units on a scale Standard Deviation 12.87
Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period Baseline (Day 1) for Day 253 ( n=92, 94, 97)	40.41 Units on a scale Standard Deviation 13.67	39.14 Units on a scale Standard Deviation 13.54	39.59 Units on a scale Standard Deviation 12.87
Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period Baseline (Day 1) for Day 365 ( n=92, 94, 97)	40.41 Units on a scale Standard Deviation 13.67	39.14 Units on a scale Standard Deviation 13.54	39.59 Units on a scale Standard Deviation 12.87

SECONDARY outcome

Timeframe: Baseline (Day 1), Days 85, 169, 253, and 365

Population: 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.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period Day 169 (n=92, 94, 97)	-2.68 Units on a scale Standard Error 1.15	-1.69 Units on a scale Standard Error 1.14	-1.08 Units on a scale Standard Error 1.13
Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period Day 253 ( n=92, 94, 97)	-3.54 Units on a scale Standard Error 1.12	-2.95 Units on a scale Standard Error 1.11	-3.06 Units on a scale Standard Error 1.09
Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period Day 85 (n=90, 94, 95)	-1.54 Units on a scale Standard Error 1.20	-1.40 Units on a scale Standard Error 1.18	-0.67 Units on a scale Standard Error 1.18
Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period Day 365 ( n=92, 94, 97)	-4.20 Units on a scale Standard Error 1.21	-3.21 Units on a scale Standard Error 1.20	-4.79 Units on a scale Standard Error 1.19

SECONDARY outcome

Timeframe: 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.

Population: All participants who received at least one dose of double-blind study medication were included in the safety population.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period Deaths	5 Participants	2 Participants	7 Participants
Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period SAEs	33 Participants	28 Participants	31 Participants
Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period Related SAEs	20 Participants	19 Participants	15 Participants
Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period AEs	93 Participants	89 Participants	94 Participants
Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period Related AEs	61 Participants	53 Participants	55 Participants
Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period Discontinued due to AEs	14 Participants	13 Participants	9 Participants

SECONDARY outcome

Timeframe: 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.

Population: All participants who received at least one dose of double-blind study medication were included in the safety population.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Participants With AEs of Special Interest During the Short-term Period Infections and Infestations	75 Participants	70 Participants	75 Participants
Participants With AEs of Special Interest During the Short-term Period Malignancies	0 Participants	1 Participants	1 Participants
Participants With AEs of Special Interest During the Short-term Period Autoimmune Disorders	4 Participants	5 Participants	3 Participants
Participants With AEs of Special Interest During the Short-term Period Acute Infusional AEs	23 Participants	18 Participants	17 Participants
Participants With AEs of Special Interest During the Short-term Period Peri-infusional AEs	23 Participants	18 Participants	17 Participants

SECONDARY outcome

Timeframe: 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.

Population: 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

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Participants With Marked Hematology Abnormalities During the Short-term Period High Absolute Basophil Count (n=98, 98, 99)	0 Participants	0 Participants	0 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period High Absolute Eosinophil Count (n=98, 98, 99)	0 Participants	3 Participants	0 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period Low Erythrocyte Count (n=98, 98, 99)	4 Participants	1 Participants	7 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period High Platelet Count (n=98, 98, 98)	1 Participants	0 Participants	1 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period Low Platelet Count (n=98, 98, 98)	1 Participants	3 Participants	1 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period High Leukocyte Count (n=98, 98, 99)	15 Participants	10 Participants	11 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period Low Leukocyte Count (n=98,98,99)	13 Participants	18 Participants	16 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period Low Absolute Neutrophils + Bands (n=98,98,99)	1 Participants	2 Participants	7 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period High Absolute Lymphocyte Count (n=98,98,99)	0 Participants	2 Participants	0 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period Low Absolute Lymphocyte Count (n=98, 98, 99)	47 Participants	32 Participants	53 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period High Absolute Monocyte Count (n=98, 98, 99)	1 Participants	1 Participants	1 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period Low Hemoglobin (n=98, 98, 99)	6 Participants	3 Participants	9 Participants
Participants With Marked Hematology Abnormalities During the Short-term Period Low Hematocrit (n=97, 98, 99)	5 Participants	1 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Population: 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

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

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Participants With Marked Laboratory Abnormalities During the Short-term Period High Serum Sodium (n=98, 98, 99)	1 Participants	2 Participants	0 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period Low Serum Potassium (n=98, 98, 99)	12 Participants	14 Participants	15 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period High Serum Potassium (n=98, 98, 99)	4 Participants	0 Participants	2 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period Low Total Calcium (n=98, 98, 99)	0 Participants	1 Participants	1 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period Low Serum Glucose (n=98, 98, 99)	12 Participants	16 Participants	18 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period Low Fasting Serum Glucose (n=72, 73, 68)	3 Participants	2 Participants	0 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period High Fasting Serum Glucose (n=72, 73, 68)	1 Participants	1 Participants	0 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period High Triglycerides (n=71, 79, 75)	2 Participants	0 Participants	0 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period Low Albumin (n=98, 98, 99)	10 Participants	6 Participants	4 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period High Total Cholesterol (n=93,93,96)	2 Participants	0 Participants	1 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period High Total Calcium (n=98, 98, 99)	1 Participants	2 Participants	1 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period High Serum Glucose (n=98, 98, 99)	2 Participants	2 Participants	2 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period Low Total Protein (n=98, 98, 99)	18 Participants	18 Participants	25 Participants
Participants With Marked Laboratory Abnormalities During the Short-term Period High Fasting Triglycerides (n=65, 64, 63)	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Population: 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

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period High G-Glutamyl Transferase	7 Participants	7 Participants	5 Participants
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period High Alkaline Phosphatase	1 Participants	1 Participants	1 Participants
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period High Aspartate Aminotransferase	2 Participants	0 Participants	0 Participants
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period High Alanine Aminotransferase	7 Participants	4 Participants	1 Participants
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period High Total Bilirubin	0 Participants	0 Participants	0 Participants
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period High Blood Urea Nitrogen	5 Participants	1 Participants	6 Participants
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period High Creatinine	16 Participants	6 Participants	12 Participants

SECONDARY outcome

Timeframe: 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.

Population: 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

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).

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=98 Participants 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 n=99 Participants 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
Participants With Marked Abnormalities Urinalysis During the Short-term Period Urine Protein (n=99,98,99)	6 Participants	3 Participants	8 Participants
Participants With Marked Abnormalities Urinalysis During the Short-term Period Urine Glucose (n=99,98,99)	1 Participants	3 Participants	0 Participants
Participants With Marked Abnormalities Urinalysis During the Short-term Period Urine Blood (n=99,98,99)	16 Participants	19 Participants	17 Participants
Participants With Marked Abnormalities Urinalysis During the Short-term Period Urine Leukocyte esterase (n=85,91,90)	10 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 0 - 12 Months

Population: 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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 1: SBP-before infusion; n=76,81,73	128.2 mmHg Standard Deviation 16.34	127.8 mmHg Standard Deviation 15.86	126.2 mmHg Standard Deviation 16.88
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 15: SBP-before infusion; n=78,78,74	127.6 mmHg Standard Deviation 18.71	125.5 mmHg Standard Deviation 16.42	129.2 mmHg Standard Deviation 17.80
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 15: SBP- 1hour after infusion; n=72,75,71	126.9 mmHg Standard Deviation 14.79	125.9 mmHg Standard Deviation 16.35	128.2 mmHg Standard Deviation 14.65
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 15: SBP-2.5 hours after infusion; n=80,78,78	130.1 mmHg Standard Deviation 14.99	124.9 mmHg Standard Deviation 15.08	131.2 mmHg Standard Deviation 15.58
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 29: SBP-before infusion; n=77,79,75	125.6 mmHg Standard Deviation 13.52	126.2 mmHg Standard Deviation 15.31	126.9 mmHg Standard Deviation 14.79
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 57: SBP-before infusion; n=74,76,70	126.4 mmHg Standard Deviation 15.47	124.8 mmHg Standard Deviation 16.21	123.0 mmHg Standard Deviation 13.21
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 57: SBP-1hour after infusion; n=74,69,68	124.6 mmHg Standard Deviation 13.40	122.1 mmHg Standard Deviation 16.73	124.4 mmHg Standard Deviation 11.22
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 57: SBP-2.5 hours after infusion; n=81,73,73	127.0 mmHg Standard Deviation 13.04	123.6 mmHg Standard Deviation 14.43	126.1 mmHg Standard Deviation 14.29
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 85: SBP- before infusion; n=73,71,67	122.0 mmHg Standard Deviation 13.52	118.7 mmHg Standard Deviation 12.85	122.2 mmHg Standard Deviation 13.67
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 113: SBP-before infusion; n=72,70,70	122.6 mmHg Standard Deviation 18.07	121.7 mmHg Standard Deviation 14.26	119.9 mmHg Standard Deviation 14.16
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 113: SBP-1hour after infusion; n=75,70,75	121.5 mmHg Standard Deviation 16.81	121.0 mmHg Standard Deviation 13.13	120.1 mmHg Standard Deviation 14.69
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 141: SBP-before infusion; n=66,70,66	121.4 mmHg Standard Deviation 15.94	119.2 mmHg Standard Deviation 15.67	118.8 mmHg Standard Deviation 14.26
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 141: SBP-1hour after infusion; n=72,71,70	120.9 mmHg Standard Deviation 18.11	117.9 mmHg Standard Deviation 15.32	120.4 mmHg Standard Deviation 13.26
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 169: SBP-before infusion; n=70,70,66	118.5 mmHg Standard Deviation 16.30	117.6 mmHg Standard Deviation 12.13	118.6 mmHg Standard Deviation 14.65
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 169: SBP-1hour after infusion; n=75,71,71	120.3 mmHg Standard Deviation 18.74	118.2 mmHg Standard Deviation 11.83	118.9 mmHg Standard Deviation 14.15
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 197: SBP-before infusion; n=68,70,64	119.0 mmHg Standard Deviation 15.58	118.9 mmHg Standard Deviation 14.72	118.7 mmHg Standard Deviation 12.34
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 197: SBP-1hour after infusion; n=72,73,70	117.7 mmHg Standard Deviation 14.76	117.4 mmHg Standard Deviation 13.10	120.4 mmHg Standard Deviation 15.29
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 225: SBP-before infusion; n=70,64,63	118.2 mmHg Standard Deviation 14.53	118.8 mmHg Standard Deviation 13.51	119.5 mmHg Standard Deviation 13.20
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 281: SBP-before infusion; n=63,66,58	120.7 mmHg Standard Deviation 14.02	116.5 mmHg Standard Deviation 14.30	120.3 mmHg Standard Deviation 12.78
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 281: SBP-1hour after infusion; n=66,65,64	119.5 mmHg Standard Deviation 15.28	119.4 mmHg Standard Deviation 13.70	121.0 mmHg Standard Deviation 12.48
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 309: SBP-before infusion; n=63,63,59	119.4 mmHg Standard Deviation 14.18	116.3 mmHg Standard Deviation 14.33	120.5 mmHg Standard Deviation 15.32
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 309: SBP-1hour after infusion; n=67,66,64	119.6 mmHg Standard Deviation 13.47	114.1 mmHg Standard Deviation 14.97	119.2 mmHg Standard Deviation 15.73
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 1: SBP-1hour after infusion; n=69,78,70	127.7 mmHg Standard Deviation 17.60	126.7 mmHg Standard Deviation 15.53	126.0 mmHg Standard Deviation 18.20
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 1: SBP-2.5 hours after infusion; n=79,81,76	127.1 mmHg Standard Deviation 16.92	127.8 mmHg Standard Deviation 12.55	126.2 mmHg Standard Deviation 15.82
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 29: SBP-1hour after infusion; n=72,75,74	126.2 mmHg Standard Deviation 12.92	125.9 mmHg Standard Deviation 15.85	128.6 mmHg Standard Deviation 15.34
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 29: SBP-2.5 hours after infusion; n=80,79,82	126.3 mmHg Standard Deviation 13.77	126.4 mmHg Standard Deviation 14.86	127.6 mmHg Standard Deviation 14.54
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 85: SBP-1hour after infusion; n=73,69,72	121.8 mmHg Standard Deviation 13.28	119.6 mmHg Standard Deviation 13.59	122.0 mmHg Standard Deviation 14.23
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 225: SBP-1hour after infusion; n=72,65,68	116.6 mmHg Standard Deviation 15.82	119.5 mmHg Standard Deviation 14.60	118.8 mmHg Standard Deviation 12.83
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 253: SBP-before infusion; n=63,66,63	120.6 mmHg Standard Deviation 15.13	120.2 mmHg Standard Deviation 17.21	120.9 mmHg Standard Deviation 14.17
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 253: SBP-1hour after infusion; n=69,67,67	118.1 mmHg Standard Deviation 14.81	117.1 mmHg Standard Deviation 15.02	119.7 mmHg Standard Deviation 14.16
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 337: SBP-before infusion; n=63,64,61	119.9 mmHg Standard Deviation 12.52	117.3 mmHg Standard Deviation 14.71	119.3 mmHg Standard Deviation 14.49
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) Day 337: SBP-1hour after infusion; n=68,65,67	120.4 mmHg Standard Deviation 12.97	117.7 mmHg Standard Deviation 16.48	119.3 mmHg Standard Deviation 13.67

SECONDARY outcome

Timeframe: 0 - 12 Months

Population: 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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=98 Participants 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 n=99 Participants 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
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 57: DBP-before infusion; n=74,76,70	80.0 mm Hg Standard Deviation 10.98	78.7 mm Hg Standard Deviation 10.69	78.7 mm Hg Standard Deviation 10.59
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 57: DBP-1hour after infusion; n=74,69,68	78.9 mm Hg Standard Deviation 11.23	75.3 mm Hg Standard Deviation 11.87	78.7 mm Hg Standard Deviation 9.25
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 169: DBP-before infusion; n=70,70,66	75.5 mm Hg Standard Deviation 12.96	74.1 mm Hg Standard Deviation 10.18	77.0 mm Hg Standard Deviation 13.16
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 169: DBP-1hour after infusion; n=75,71,71	76.5 mm Hg Standard Deviation 13.24	74.4 mm Hg Standard Deviation 9.41	76.4 mm Hg Standard Deviation 12.81
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 197: DBP-before infusion; n=68,70,64	76.8 mm Hg Standard Deviation 11.29	75.8 mm Hg Standard Deviation 10.79	75.8 mm Hg Standard Deviation 11.16
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 197: DBP-1hour after infusion; n=72,73,70	76.1 mm Hg Standard Deviation 11.63	74.5 mm Hg Standard Deviation 10.55	75.4 mm Hg Standard Deviation 12.21
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 225: DBP-before infusion; n=70,64,63	74.5 mm Hg Standard Deviation 12.39	73.6 mm Hg Standard Deviation 9.68	75.7 mm Hg Standard Deviation 10.77
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 225: DBP-1hour after infusion; n=72,65,68	75.0 mm Hg Standard Deviation 11.67	74.5 mm Hg Standard Deviation 10.95	76.0 mm Hg Standard Deviation 10.28
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 253: DBP-before infusion; n=63,66,63	76.1 mm Hg Standard Deviation 11.54	75.9 mm Hg Standard Deviation 11.27	77.1 mm Hg Standard Deviation 10.26
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 253: DBP-1hour after infusion; n=69,67,67	74.5 mm Hg Standard Deviation 11.51	74.9 mm Hg Standard Deviation 10.25	75.7 mm Hg Standard Deviation 10.20
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 309: DBP-before infusion; n=63,63,59	78.1 mm Hg Standard Deviation 9.73	72.9 mm Hg Standard Deviation 8.90	77.4 mm Hg Standard Deviation 11.83
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 309: DBP-1hour after infusion; n=67,66,64	76.4 mm Hg Standard Deviation 10.81	72.9 mm Hg Standard Deviation 9.86	76.6 mm Hg Standard Deviation 10.75
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 337: DBP-before infusion; n=63,64,61	78.0 mm Hg Standard Deviation 10.54	73.4 mm Hg Standard Deviation 9.52	76.2 mm Hg Standard Deviation 10.65
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 337: DBP-1hour after infusion; n=68,65,67	78.1 mm Hg Standard Deviation 9.72	73.3 mm Hg Standard Deviation 9.82	76.1 mm Hg Standard Deviation 11.19
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 1: DBP-before infusion; n=76,81,73	80.8 mm Hg Standard Deviation 11.69	80.6 mm Hg Standard Deviation 12.57	80.4 mm Hg Standard Deviation 12.40
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 1: DBP-1hour after infusion; n=69,78,70	79.6 mm Hg Standard Deviation 13.57	79.6 mm Hg Standard Deviation 12.59	80.1 mm Hg Standard Deviation 13.34
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 1: DBP-2.5 hours after infusion; n=79,81,76	79.3 mm Hg Standard Deviation 12.73	79.0 mm Hg Standard Deviation 10.93	80.9 mm Hg Standard Deviation 11.24
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 15: DBP-before infusion; n=78,78,74	81.1 mm Hg Standard Deviation 12.56	80.0 mm Hg Standard Deviation 12.89	82.6 mm Hg Standard Deviation 12.89
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 15: DBP- 1hour after infusion; n=72,75,71	79.6 mm Hg Standard Deviation 10.87	78.7 mm Hg Standard Deviation 11.58	80.4 mm Hg Standard Deviation 10.96
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 15: DBP-2.5 hours after infusion; n=80,78,78	81.4 mm Hg Standard Deviation 11.79	78.0 mm Hg Standard Deviation 11.27	82.8 mm Hg Standard Deviation 11.38
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 29: DBP-before infusion; n=77,79,75	79.6 mm Hg Standard Deviation 11.08	78.8 mm Hg Standard Deviation 12.14	81.3 mm Hg Standard Deviation 9.95
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 29: DBP-1hour after infusion; n=72,75,74	79.9 mm Hg Standard Deviation 10.06	78.0 mm Hg Standard Deviation 12.84	80.8 mm Hg Standard Deviation 10.36
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 29: DBP-2.5 hours after infusion; n=80,79,82	78.5 mm Hg Standard Deviation 9.75	78.2 mm Hg Standard Deviation 11.62	79.5 mm Hg Standard Deviation 11.08
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 57: DBP-2.5 hours after infusion; n=81,73,73	79.5 mm Hg Standard Deviation 10.06	76.1 mm Hg Standard Deviation 10.49	80.2 mm Hg Standard Deviation 9.60
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 85: DBP- before infusion; n=73,71,67	79.7 mm Hg Standard Deviation 11.01	75.2 mm Hg Standard Deviation 9.39	78.7 mm Hg Standard Deviation 9.94
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 85: DBP-1hour after infusion; n=73,69,72	78.1 mm Hg Standard Deviation 11.72	75.6 mm Hg Standard Deviation 9.29	78.1 mm Hg Standard Deviation 10.58
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 113: DBP-before infusion; n=72,70,70	78.5 mm Hg Standard Deviation 13.75	77.0 mm Hg Standard Deviation 10.58	76.7 mm Hg Standard Deviation 11.62
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 113: DBP-1hour after infusion; n=75,70,75	76.1 mm Hg Standard Deviation 12.13	76.3 mm Hg Standard Deviation 10.74	76.9 mm Hg Standard Deviation 11.61
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 141: DBP-before infusion; n=66,70,66	78.8 mm Hg Standard Deviation 11.32	74.0 mm Hg Standard Deviation 12.08	76.5 mm Hg Standard Deviation 11.48
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 141: DBP-1hour after infusion; n=72,71,70	77.8 mm Hg Standard Deviation 11.24	74.7 mm Hg Standard Deviation 11.54	76.1 mm Hg Standard Deviation 11.69
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 281: DBP-before infusion; n=63,66,58	77.6 mm Hg Standard Deviation 10.89	73.3 mm Hg Standard Deviation 9.50	76.6 mm Hg Standard Deviation 9.31
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) Day 281: DBP-1hour after infusion; n=66,65,64	75.9 mm Hg Standard Deviation 10.49	74.5 mm Hg Standard Deviation 9.73	76.6 mm Hg Standard Deviation 10.15

SECONDARY outcome

Timeframe: 0 - 12 Months

Population: 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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Vital Signs Summary During the Short-term Period: Heart Rate Day 15: 1hour after infusion; n=96,94,98	81.3 beats per minute Standard Deviation 12.21	80.1 beats per minute Standard Deviation 11.31	82.6 beats per minute Standard Deviation 11.70
Vital Signs Summary During the Short-term Period: Heart Rate Day 15: 2.5 hours after infusion; n=93,92,95	81.5 beats per minute Standard Deviation 11.18	81.7 beats per minute Standard Deviation 9.88	84.7 beats per minute Standard Deviation 12.65
Vital Signs Summary During the Short-term Period: Heart Rate Day 29: before infusion; n=94,93,99	83.7 beats per minute Standard Deviation 12.13	80.8 beats per minute Standard Deviation 11.85	83.0 beats per minute Standard Deviation 12.91
Vital Signs Summary During the Short-term Period: Heart Rate Day 29: 1hour after infusion; n=93,92,99	81.7 beats per minute Standard Deviation 12.23	79.9 beats per minute Standard Deviation 9.60	81.7 beats per minute Standard Deviation 11.00
Vital Signs Summary During the Short-term Period: Heart Rate Day 29: 2.5 hours after infusion; n=92,90,97	81.3 beats per minute Standard Deviation 10.26	82.1 beats per minute Standard Deviation 9.56	84.7 beats per minute Standard Deviation 11.41
Vital Signs Summary During the Short-term Period: Heart Rate Day 57: before infusion; n=93,88,84	83.4 beats per minute Standard Deviation 11.04	82.2 beats per minute Standard Deviation 12.09	82.8 beats per minute Standard Deviation 13.00
Vital Signs Summary During the Short-term Period: Heart Rate Day 57: 1hour after infusion; n=93,84,94	81.0 beats per minute Standard Deviation 10.02	81.6 beats per minute Standard Deviation 10.52	81.8 beats per minute Standard Deviation 10.80
Vital Signs Summary During the Short-term Period: Heart Rate Day 57: 2.5 hours after infusion; n=91,84,91	82.5 beats per minute Standard Deviation 10.13	83.4 beats per minute Standard Deviation 12.20	83.8 beats per minute Standard Deviation 11.09
Vital Signs Summary During the Short-term Period: Heart Rate Day 85: before infusion; n=89,86,91	84.8 beats per minute Standard Deviation 12.35	82.3 beats per minute Standard Deviation 11.00	82.5 beats per minute Standard Deviation 10.99
Vital Signs Summary During the Short-term Period: Heart Rate Day 85: 1hour after infusion; n=88,84,89	83.3 beats per minute Standard Deviation 11.02	80.4 beats per minute Standard Deviation 10.67	83.5 beats per minute Standard Deviation 9.50
Vital Signs Summary During the Short-term Period: Heart Rate Day 113: 1hour after infusion; n=87,80,91	81.8 beats per minute Standard Deviation 10.64	80.2 beats per minute Standard Deviation 9.98	82.6 beats per minute Standard Deviation 10.62
Vital Signs Summary During the Short-term Period: Heart Rate Day 141: before infusion; n=84,82,89	82.8 beats per minute Standard Deviation 11.75	79.3 beats per minute Standard Deviation 11.20	82.6 beats per minute Standard Deviation 12.74
Vital Signs Summary During the Short-term Period: Heart Rate Day 141: 1hour after infusion; n=84,81,86	81.4 beats per minute Standard Deviation 10.92	79.1 beats per minute Standard Deviation 10.59	81.3 beats per minute Standard Deviation 11.30
Vital Signs Summary During the Short-term Period: Heart Rate Day 169: before infusion; n=85,82,86	80.1 beats per minute Standard Deviation 10.01	78.0 beats per minute Standard Deviation 11.35	79.1 beats per minute Standard Deviation 10.95
Vital Signs Summary During the Short-term Period: Heart Rate Day 169: 1hour after infusion; n=84,82,85	79.5 beats per minute Standard Deviation 10.43	78.8 beats per minute Standard Deviation 10.97	81.4 beats per minute Standard Deviation 12.30
Vital Signs Summary During the Short-term Period: Heart Rate Day 197: before infusion; n=83,82,84	81.7 beats per minute Standard Deviation 10.54	78.1 beats per minute Standard Deviation 10.72	79.3 beats per minute Standard Deviation 11.58
Vital Signs Summary During the Short-term Period: Heart Rate Day 197: 1hour after infusion; n=82,82,85	79.8 beats per minute Standard Deviation 9.84	78.7 beats per minute Standard Deviation 10.25	79.6 beats per minute Standard Deviation 11.77
Vital Signs Summary During the Short-term Period: Heart Rate Day 225: before infusion; n=83,76,81	80.1 beats per minute Standard Deviation 10.04	77.6 beats per minute Standard Deviation 10.59	78.9 beats per minute Standard Deviation 10.00
Vital Signs Summary During the Short-term Period: Heart Rate Day 253: 1hour after infusion; n=78,77,81	78.8 beats per minute Standard Deviation 9.01	79.3 beats per minute Standard Deviation 10.64	79.5 beats per minute Standard Deviation 10.91
Vital Signs Summary During the Short-term Period: Heart Rate Day 281: before infusion; n=75,76,77	80.1 beats per minute Standard Deviation 10.56	78.3 beats per minute Standard Deviation 11.16	79.3 beats per minute Standard Deviation 10.24
Vital Signs Summary During the Short-term Period: Heart Rate Day 281: 1hour after infusion; n=74,76,76	78.0 beats per minute Standard Deviation 9.93	77.6 beats per minute Standard Deviation 9.46	78.7 beats per minute Standard Deviation 9.95
Vital Signs Summary During the Short-term Period: Heart Rate Day 309: before infusion; n=76,75,77	79.8 beats per minute Standard Deviation 10.89	76.5 beats per minute Standard Deviation 10.07	78.2 beats per minute Standard Deviation 10.66
Vital Signs Summary During the Short-term Period: Heart Rate Day 309: 1hour after infusion; n=76,74,77	77.9 beats per minute Standard Deviation 10.40	77.4 beats per minute Standard Deviation 9.81	78.4 beats per minute Standard Deviation 11.49
Vital Signs Summary During the Short-term Period: Heart Rate Day 337: before infusion; n=73,75,80	78.5 beats per minute Standard Deviation 11.77	76.4 beats per minute Standard Deviation 9.95	78.9 beats per minute Standard Deviation 11.50
Vital Signs Summary During the Short-term Period: Heart Rate Day 337: 1hour after infusion; n=73,73,79	77.6 beats per minute Standard Deviation 9.85	77.4 beats per minute Standard Deviation 9.73	78.3 beats per minute Standard Deviation 11.11
Vital Signs Summary During the Short-term Period: Heart Rate Day 1: before infusion; n=99,98,100	82.4 beats per minute Standard Deviation 11.17	79.2 beats per minute Standard Deviation 10.84	82.6 beats per minute Standard Deviation 12.11
Vital Signs Summary During the Short-term Period: Heart Rate Day 1: 1hour after infusion; n=98,98,98	81.3 beats per minute Standard Deviation 11.08	79.6 beats per minute Standard Deviation 9.71	81.9 beats per minute Standard Deviation 10.64
Vital Signs Summary During the Short-term Period: Heart Rate Day 1: 2.5 hours after infusion; n=97,96,96	81.8 beats per minute Standard Deviation 11.38	82.2 beats per minute Standard Deviation 11.25	83.8 beats per minute Standard Deviation 11.51
Vital Signs Summary During the Short-term Period: Heart Rate Day 15: before infusion; n=97,93,99	83.1 beats per minute Standard Deviation 12.08	81.0 beats per minute Standard Deviation 11.31	83.7 beats per minute Standard Deviation 12.84
Vital Signs Summary During the Short-term Period: Heart Rate Day 113: before infusion; n=88,82,92	82.1 beats per minute Standard Deviation 11.46	80.4 beats per minute Standard Deviation 11.88	83.0 beats per minute Standard Deviation 11.78
Vital Signs Summary During the Short-term Period: Heart Rate Day 225: 1hour after infusion; n=83,76,81	79.1 beats per minute Standard Deviation 9.86	78.0 beats per minute Standard Deviation 9.83	80.2 beats per minute Standard Deviation 10.03
Vital Signs Summary During the Short-term Period: Heart Rate Day 253: before infusion; n=78,77,81	81.4 beats per minute Standard Deviation 11.32	79.1 beats per minute Standard Deviation 11.30	81.5 beats per minute Standard Deviation 12.17

SECONDARY outcome

Timeframe: 0 - 12 Months

Population: 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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Vital Signs Summary During the Short-term Period: Temperature Day 1: before infusion; n=99,98,99	36.6 degree celcius Standard Deviation 0.48	36.5 degree celcius Standard Deviation 0.42	36.5 degree celcius Standard Deviation 0.47
Vital Signs Summary During the Short-term Period: Temperature Day 1: 1hour after infusion; n=98,96,97	36.6 degree celcius Standard Deviation 0.50	36.5 degree celcius Standard Deviation 0.46	36.6 degree celcius Standard Deviation 0.51
Vital Signs Summary During the Short-term Period: Temperature Day 1: 2.5 hours after infusion; n=97,93,97	36.6 degree celcius Standard Deviation 0.45	36.5 degree celcius Standard Deviation 0.43	36.6 degree celcius Standard Deviation 0.49
Vital Signs Summary During the Short-term Period: Temperature Day 15: before infusion; n=97,94,99	36.5 degree celcius Standard Deviation 0.50	36.5 degree celcius Standard Deviation 0.45	36.5 degree celcius Standard Deviation 0.47
Vital Signs Summary During the Short-term Period: Temperature Day 15: 1hour after infusion; n=96,91,98	36.6 degree celcius Standard Deviation 0.47	36.5 degree celcius Standard Deviation 0.45	36.5 degree celcius Standard Deviation 0.53
Vital Signs Summary During the Short-term Period: Temperature Day 29: 1hour after infusion; n=93,91,98	36.5 degree celcius Standard Deviation 0.50	36.5 degree celcius Standard Deviation 0.44	36.5 degree celcius Standard Deviation 0.49
Vital Signs Summary During the Short-term Period: Temperature Day 29: 2.5 hours after infusion; n=92,90,97	36.5 degree celcius Standard Deviation 0.46	36.5 degree celcius Standard Deviation 0.47	36.5 degree celcius Standard Deviation 0.49
Vital Signs Summary During the Short-term Period: Temperature Day 57: before infusion; n=93,88,93	36.5 degree celcius Standard Deviation 0.46	36.4 degree celcius Standard Deviation 0.50	36.5 degree celcius Standard Deviation 0.49
Vital Signs Summary During the Short-term Period: Temperature Day 57: 1hour after infusion; n=93,83,94	36.1 degree celcius Standard Deviation 3.58	36.4 degree celcius Standard Deviation 0.46	36.6 degree celcius Standard Deviation 0.49
Vital Signs Summary During the Short-term Period: Temperature Day 57: 2.5 hours after infusion; n=90,84,90	36.5 degree celcius Standard Deviation 0.41	36.5 degree celcius Standard Deviation 0.48	36.5 degree celcius Standard Deviation 0.53
Vital Signs Summary During the Short-term Period: Temperature Day 85: before infusion; n=89,86,91	36.4 degree celcius Standard Deviation 0.52	36.4 degree celcius Standard Deviation 0.45	36.5 degree celcius Standard Deviation 0.45
Vital Signs Summary During the Short-term Period: Temperature Day 85: 1hour after infusion; n=87,84,89	36.4 degree celcius Standard Deviation 0.51	36.4 degree celcius Standard Deviation 0.50	36.5 degree celcius Standard Deviation 0.49
Vital Signs Summary During the Short-term Period: Temperature Day 141: 1hour after infusion; n=84,80,86	36.5 degree celcius Standard Deviation 0.45	36.4 degree celcius Standard Deviation 0.41	36.5 degree celcius Standard Deviation 0.49
Vital Signs Summary During the Short-term Period: Temperature Day 169: before infusion; n=85,81,86	36.5 degree celcius Standard Deviation 0.52	36.4 degree celcius Standard Deviation 0.48	36.5 degree celcius Standard Deviation 0.46
Vital Signs Summary During the Short-term Period: Temperature Day 169: 1hour after infusion; n=84,80,84	36.4 degree celcius Standard Deviation 0.47	36.4 degree celcius Standard Deviation 0.44	36.5 degree celcius Standard Deviation 0.46
Vital Signs Summary During the Short-term Period: Temperature Day 197: before infusion; n=83,82,85	36.5 degree celcius Standard Deviation 0.58	36.3 degree celcius Standard Deviation 0.45	36.5 degree celcius Standard Deviation 0.45
Vital Signs Summary During the Short-term Period: Temperature Day 197: 1hour after infusion; n=82,81,84	36.4 degree celcius Standard Deviation 0.61	36.3 degree celcius Standard Deviation 0.49	36.5 degree celcius Standard Deviation 0.48
Vital Signs Summary During the Short-term Period: Temperature Day 225: before infusion; n=83,76,81	36.5 degree celcius Standard Deviation 0.56	36.4 degree celcius Standard Deviation 0.48	36.4 degree celcius Standard Deviation 0.55
Vital Signs Summary During the Short-term Period: Temperature Day 225: 1hour after infusion; n=83,75,81	36.5 degree celcius Standard Deviation 0.56	36.4 degree celcius Standard Deviation 0.45	36.5 degree celcius Standard Deviation 0.54
Vital Signs Summary During the Short-term Period: Temperature Day 253: before infusion; n=78,77,80	36.5 degree celcius Standard Deviation 0.52	36.4 degree celcius Standard Deviation 0.44	36.5 degree celcius Standard Deviation 0.46
Vital Signs Summary During the Short-term Period: Temperature Day 281: before infusion; n=75,76,77	36.5 degree celcius Standard Deviation 0.49	36.4 degree celcius Standard Deviation 0.43	36.5 degree celcius Standard Deviation 0.49
Vital Signs Summary During the Short-term Period: Temperature Day 281: 1hour after infusion; n=74,76,76	36.5 degree celcius Standard Deviation 0.51	36.4 degree celcius Standard Deviation 0.46	36.5 degree celcius Standard Deviation 0.47
Vital Signs Summary During the Short-term Period: Temperature Day 309: before infusion; n=76,75,77	36.5 degree celcius Standard Deviation 0.49	36.3 degree celcius Standard Deviation 0.51	36.5 degree celcius Standard Deviation 0.54
Vital Signs Summary During the Short-term Period: Temperature Day 309: 1hour after infusion; n=75,73,77	36.5 degree celcius Standard Deviation 0.51	36.4 degree celcius Standard Deviation 0.43	36.5 degree celcius Standard Deviation 0.54
Vital Signs Summary During the Short-term Period: Temperature Day 337: before infusion; n=73,75,79	36.5 degree celcius Standard Deviation 0.47	36.4 degree celcius Standard Deviation 0.46	36.5 degree celcius Standard Deviation 0.50
Vital Signs Summary During the Short-term Period: Temperature Day 337: 1hour after infusion; n=73,72,79	36.5 degree celcius Standard Deviation 0.59	36.4 degree celcius Standard Deviation 0.49	36.5 degree celcius Standard Deviation 0.52
Vital Signs Summary During the Short-term Period: Temperature Day 15: 2.5 hours after infusion; n=93,91,95	36.6 degree celcius Standard Deviation 0.47	36.5 degree celcius Standard Deviation 0.44	36.6 degree celcius Standard Deviation 0.53
Vital Signs Summary During the Short-term Period: Temperature Day 29: before infusion; n=94,93,99	36.5 degree celcius Standard Deviation 0.51	36.4 degree celcius Standard Deviation 0.489	36.5 degree celcius Standard Deviation 0.48
Vital Signs Summary During the Short-term Period: Temperature Day 113: before infusion; n=88,82,92	36.5 degree celcius Standard Deviation 0.60	36.4 degree celcius Standard Deviation 0.50	36.5 degree celcius Standard Deviation 0.54
Vital Signs Summary During the Short-term Period: Temperature Day 113: 1hour after infusion; n=87,79,91	36.4 degree celcius Standard Deviation 0.49	36.4 degree celcius Standard Deviation 0.44	36.5 degree celcius Standard Deviation 0.51
Vital Signs Summary During the Short-term Period: Temperature Day 141: before infusion; n=84,81,89	36.5 degree celcius Standard Deviation 0.50	36.4 degree celcius Standard Deviation 0.45	36.5 degree celcius Standard Deviation 0.47
Vital Signs Summary During the Short-term Period: Temperature Day 253: 1hour after infusion; n=78,77,81	36.5 degree celcius Standard Deviation 0.54	36.4 degree celcius Standard Deviation 0.42	36.5 degree celcius Standard Deviation 0.49

SECONDARY outcome

Timeframe: Day 169, Day 365

Population: 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

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=95 Participants 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 n=96 Participants 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 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
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period CTLA4 and possibly Ig; Day 169 (n=90)	2 Participants	1 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period CTLA4 and possibly Ig; Day 365 (n=74)	1 Participants	0 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period CTLA4 and possibly Ig; Overall Post visits (n=20)	7 Participants	5 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period CTLA4 and possibly Ig; Overall (n=96)	9 Participants	6 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period Ig/Jn region; Day 169 (n=90)	0 Participants	0 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period Ig/Jn region; Overall on Post visits (n=20)	0 Participants	1 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period Ig/Jn region; Overall (n=95)	1 Participants	1 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period CTLA4 and possibly Ig;Overall on TRT visits (n=90)	3 Participants	1 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period Ig/Jn region; Day 365 (n=78)	1 Participants	0 Participants	—
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period Ig/Jn region; Overall on TRT visits (n=90)	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1)

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Baseline Quantitative Immunoglobulins During the Short-term Period Immunoglobulin IgA	246.28 mg/dL Standard Error 99.55	218.04 mg/dL Standard Error 88.23	230.23 mg/dL Standard Error 107.34
Baseline Quantitative Immunoglobulins During the Short-term Period Immunoglobulin IgG	939.80 mg/dL Standard Error 423.66	864.12 mg/dL Standard Error 459.44	1013.17 mg/dL Standard Error 516.24
Baseline Quantitative Immunoglobulins During the Short-term Period Immunoglobulin IgM	100.96 mg/dL Standard Error 79.70	97.10 mg/dL Standard Error 55.18	98.49 mg/dL Standard Error 57.71

SECONDARY outcome

Timeframe: Day 365

Population: All randomized participants who received treatment. n=Participants with both postbaseline and baseline measurements

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

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Change in Quantitative Immunoglobulin From Baseline During Short-term Period Ig A (n=76, 73, 78)	-32.83 mg/dL Standard Deviation 8.47	-34.48 mg/dL Standard Deviation 6.87	-26.51 mg/dL Standard Deviation 8.20
Change in Quantitative Immunoglobulin From Baseline During Short-term Period IgG (n=76, 73, 78)	41.41 mg/dL Standard Deviation 47.17	27.21 mg/dL Standard Deviation 43.84	23.42 mg/dL Standard Deviation 49.07
Change in Quantitative Immunoglobulin From Baseline During Short-term Period IgM (n=76, 73, 78)	-17.76 mg/dL Standard Deviation 5.28	-19.38 mg/dL Standard Deviation 4.76	-20.62 mg/dL Standard Deviation 4.89

SECONDARY outcome

Timeframe: End of short-term period (Day 365) to termination of the long-term extension period

Population: All participants who entered and received at least 1 dose of study medication during the long-term extension period

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=69 Participants 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 n=66 Participants 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 n=74 Participants 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
Number of Participants Achieving Complete Response by ACCESS Definition Day 365	29 participants	30 participants	25 participants
Number of Participants Achieving Complete Response by ACCESS Definition Day 645 (n=55, 56, 61)	27 participants	28 participants	25 participants

SECONDARY outcome

Timeframe: At Day 365 (end of Short-term Period) and Day 645

Population: All participants who entered and received at least 1 dose of study medication during the long-term extension period

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=69 Participants 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 n=66 Participants 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 n=74 Participants 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
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 Day 365	43 Participants	39 Participants	42 Participants
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 Day 645 (n=59, 59, and 62)	45 Participants	29 Participants	36 Participants

SECONDARY outcome

Timeframe: Day 365 to termination of the long-term extension phase

Population: 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

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=70 Participants 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 n=67 Participants 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 n=74 Participants 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
Mean Change From Baseline in SLICC/ACR Damage Index Day 365 (n=69, 65, 74)	-0.12 Units on a scale Standard Error 0.06	-0.17 Units on a scale Standard Error 0.09	-0.08 Units on a scale Standard Error 0.07
Mean Change From Baseline in SLICC/ACR Damage Index Day 729 (n=66, 65, 69)	-0.21 Units on a scale Standard Error 0.10	-0.28 Units on a scale Standard Error 0.09	-0.10 Units on a scale Standard Error 0.08
Mean Change From Baseline in SLICC/ACR Damage Index Day 1093 (n=41, 38, 44)	-.27 Units on a scale Standard Error 0.13	-0.16 Units on a scale Standard Error 0.10	0.02 Units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 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.

Population: All participants who entered and received at least 1 dose of study medication during the long-term extension period

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=211 Participants 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 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 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
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 Deaths	5 Participants	—	—
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 Treatment-related AEs	100 Participants	—	—
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 Discontinuations due to AEs	10 Participants	—	—
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 SAEs	32 Participants	—	—
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 Treatment-related SAEs	14 Participants	—	—
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 Discontinuations due to SAEs	5 Participants	—	—
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 AEs	183 Participants	—	—

SECONDARY outcome

Timeframe: Day 365 to end of long-term extension period

Population: Immunogenicity analysis population consisted of participants who received at least 1 dose of abatacept and had at least 1 immunogenicity result available.

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

Outcome measures

Measure	Abatacept 30/10 mg/kg n=209 Participants 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 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 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
Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period	17 Participants	—	—

SECONDARY outcome

Timeframe: At Day 365 (end of short-term period) and Day 645

Population: All randomized participants who received treatment.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=9 Participants 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 n=66 Participants 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 n=74 Participants 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
Number of Participants Achieving Renal Response Day 365	46 participants	66 participants	74 participants
Number of Participants Achieving Renal Response Day 645 (n=59, 59, 62)	47 participants	59 participants	62 participants

SECONDARY outcome

Timeframe: From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period

Population: All participants who entered and received at least 1 dose of study medication during the long-term extension period

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=211 Participants 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 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 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
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Hemoglobin (low)	13 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Hemoglobin (high)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Hematocrit (n=210) (low)	11 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Erythrocytes (low)	10 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Erythrocytes (high)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Platelet count (n=210) (high)	0 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Leukocytes (low)	40 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Leukocytes (high)	9 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Neutrophils + Bands (absolute) (low)	4 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Neutrophils + Bands (absolute) (high)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Lymphocytes (absolute) (low)	59 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Monocytes (absolute) (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Monocytes (absolute) (high)	0 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Basophils (absolute) (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Basophils (absolute) (high)	0 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Eosinophils (absolute) (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Eosinophils (absolute) (high)	8 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Alkaline phosphatase (ALP) (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period ALP (high)	3 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Aspartate aminotransferase (AST) (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period AST (high)	3 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Alanine aminotransferase (ALT) (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period ALT (high)	5 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period G-glutamyl transferase (GGT) (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period GGT (high)	14 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Blood urea nitrogen (BUN) (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Hematocrit (n=210) (high)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Platelet count (n=210) (low)	1 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Lymphocytes (absolute) (high)	0 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Bilirubin, total (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Bilirubin, total (high)	0 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period BUN (high)	9 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Creatinine (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period Creatinine (high)	16 Participants	—	—

SECONDARY outcome

Timeframe: From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period

Population: All participants who entered and received at least 1 dose of study medication during the long-term extension period

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=211 Participants 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 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 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
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Sodium, serum (low)	1 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Sodium, serum (high)	2 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Potassium, serum (n=210) (low)	11 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Potassium, serum (n=210) (high)	3 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Chloride, serum (low)	0 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Chloride, serum (high)	0 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Calcium, total (n=210) (low)	1 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Calcium, total (n=210) (high)	2 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Glucose, serum (low)	23 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Glucose, serum (high)	2 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Albumin (low)	12 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Albumin (high)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Leukocyte esterase, urine (low) (n=185)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Leukocyte esterase, urine (high) (n=185)	27 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Glucose, fasting serum (low) (n=143)	2 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Glucose, fasting serum (high) (n=143)	2 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Protein, total (low)	19 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Protein, total (high)	0 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Cholesterol, total (low) (n=32)	32 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Cholesterol, total (high) (n=32)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Triglycerides (low) (n=20)	20 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Triglycerides (high) (n=20)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Triglycerides, fasting (low) (n=18)	18 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Triglycerides, fasting (high) (n=18)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Protein, urine (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Protein, urine (high)	9 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Glucose, urine (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Glucose, urine (high)	1 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Blood, urine (low)	NA Participants Not evaluated	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Blood, urine (high)	35 Participants	—	—

SECONDARY outcome

Timeframe: From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period

Population: All participants who entered and received at least 1 dose of study medication during the long-term extension period

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=211 Participants 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 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 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
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Protein, urine (low)	NA Participants Not evaluable	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Protein, urine (high)	9 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Glucose, urine (low)	NA Participants Not evaluable	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Glucose, urine (high)	1 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Blood, urine (low)	NA Participants Not evaluable	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Blood, urine (high)	35 Participants	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Leukocyte esterase, urine (low) (n=185)	NA Participants Not evaluable	—	—
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) Leukocyte esterase, urine (high) (n=185)	27 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12

Population: All randomized participants who received treatment.

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.

Outcome measures

Measure	Abatacept 30/10 mg/kg n=99 Participants 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 n=99 Participants 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 n=100 Participants 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
Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period Complete Renal Response	24 Participants	21 Participants	20 Participants
Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period No Renal Response	61 Participants	69 Participants	66 Participants
Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period Partial Renal Response	14 Participants	9 Participants	14 Participants

Adverse Events

Abatacept 30/10 mg/kg

Serious events: 33 serious events

Other events: 83 other events

Deaths: 0 deaths

Abatacept 10/10 mg/kg

Serious events: 28 serious events

Other events: 75 other events

Deaths: 0 deaths

Placebo

Serious events: 31 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Measure	Abatacept 30/10 mg/kg n=99 participants at risk 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 n=99 participants at risk 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 n=99 participants at risk；n=100 participants at risk 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
Infections and infestations GASTROENTERITIS	5.1% 5/99 • 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.	1.0% 1/99 • 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.	2.0% 2/100 • 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.
Infections and infestations PNEUMONIA	4.0% 4/99 • 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.	4.0% 4/99 • 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.	3.0% 3/100 • 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.
Infections and infestations HERPES ZOSTER	3.0% 3/99 • 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.	6.1% 6/99 • 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.	0.00% 0/100 • 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.
Infections and infestations CELLULITIS	1.0% 1/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Infections and infestations SUBCUTANEOUS ABSCESS	1.0% 1/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Infections and infestations CRYPTOCOCCOSIS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations JOINT ABSCESS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations LUNG INFECTION	1.0% 1/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations DIARRHOEA INFECTIOUS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations DISSEMINATED TUBERCULOSIS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations LOCALISED INFECTION	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations PARONYCHIA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations PNEUMOCYSTIS JIROVECI PNEUMONIA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations PNEUMONIA BACTERIAL	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations PYELONEPHRITIS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations TUBO-OVARIAN ABSCESS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations UROSEPSIS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/99 • 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.	2.0% 2/99 • 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.	2.0% 2/100 • 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.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/99 • 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.	1.0% 1/99 • 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.	2.0% 2/100 • 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.
Infections and infestations LUNG ABSCESS	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Infections and infestations OSTEOMYELITIS	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Infections and infestations SEPTIC SHOCK	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Infections and infestations TUBERCULOSIS	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Infections and infestations BRONCHOPNEUMONIA	0.00% 0/99 • 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.	0.00% 0/99 • 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.	2.0% 2/100 • 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.
Infections and infestations CANDIDIASIS	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations HISTOPLASMOSIS DISSEMINATED	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations MALARIA	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations MENINGITIS	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations OTITIS MEDIA	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations OTITIS MEDIA CHRONIC	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations PULMONARY TUBERCULOSIS	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations SEPSIS	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Infections and infestations VIRAL INFECTION	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Renal and urinary disorders RENAL FAILURE	2.0% 2/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Renal and urinary disorders RENAL FAILURE ACUTE	1.0% 1/99 • 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.	1.0% 1/99 • 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.	2.0% 2/100 • 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.
Renal and urinary disorders LUPUS NEPHRITIS	1.0% 1/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Renal and urinary disorders NEPHRITIS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	2.0% 2/100 • 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.
Renal and urinary disorders NEPHROTIC SYNDROME	1.0% 1/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Renal and urinary disorders RENAL IMPAIRMENT	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Renal and urinary disorders GLOMERULONEPHRITIS CHRONIC	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Renal and urinary disorders GLOMERULONEPHRITIS	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Renal and urinary disorders RENAL FAILURE CHRONIC	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Cardiac disorders MYOCARDITIS	2.0% 2/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Cardiac disorders CARDIAC FAILURE	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
General disorders PYREXIA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	2.0% 2/100 • 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.
General disorders INFUSION RELATED REACTION	1.0% 1/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
General disorders MULTI-ORGAN FAILURE	1.0% 1/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
General disorders GENERALISED OEDEMA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
General disorders DRUG INEFFECTIVE	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/99 • 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.	0.00% 0/99 • 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.	2.0% 2/100 • 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.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Musculoskeletal and connective tissue disorders SYSTEMIC LUPUS ERYTHEMATOSUS	1.0% 1/99 • 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.	2.0% 2/99 • 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.	4.0% 4/100 • 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.
Musculoskeletal and connective tissue disorders JOINT EFFUSION	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Musculoskeletal and connective tissue disorders CHONDRITIS	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Musculoskeletal and connective tissue disorders POLYARTHRITIS	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Blood and lymphatic system disorders THROMBOCYTOPENIA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Blood and lymphatic system disorders THROMBOTIC MICROANGIOPATHY	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/99 • 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.	1.0% 1/99 • 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.	1.0% 1/100 • 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.
Blood and lymphatic system disorders LYMPHOCYTOSIS	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Blood and lymphatic system disorders HAEMOLYTIC URAEMIC SYNDROME	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Nervous system disorders PRESYNCOPE	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Nervous system disorders CONVULSION	0.00% 0/99 • 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.	2.0% 2/99 • 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.	0.00% 0/100 • 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.
Nervous system disorders HEADACHE	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Nervous system disorders EPILEPSY	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Gastrointestinal disorders VASCULITIS GASTROINTESTINAL	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Gastrointestinal disorders DIARRHOEA	0.00% 0/99 • 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.	1.0% 1/99 • 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.	1.0% 1/100 • 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.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Gastrointestinal disorders ASCITES	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Reproductive system and breast disorders SCROTAL OEDEMA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Vascular disorders DEEP VEIN THROMBOSIS	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Vascular disorders HYPERTENSION	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Metabolism and nutrition disorders HYPERKALAEMIA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Ear and labyrinth disorders VERTIGO	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Eye disorders DIPLOPIA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Immune system disorders HYPERSENSITIVITY	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Skin and subcutaneous tissue disorders ANGIOEDEMA	1.0% 1/99 • 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.	0.00% 0/99 • 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.	0.00% 0/100 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) KAPOSI'S SARCOMA	0.00% 0/99 • 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.	1.0% 1/99 • 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.	1.0% 1/100 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HAEMANGIOMA OF LIVER	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HISTIOCYTOSIS HAEMATOPHAGIC	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Investigations HAEMATOCRIT DECREASED	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/99 • 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.	1.0% 1/99 • 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.	0.00% 0/100 • 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.
Hepatobiliary disorders GALLBLADDER POLYP	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.
Psychiatric disorders DEPRESSION	0.00% 0/99 • 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.	0.00% 0/99 • 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.	1.0% 1/100 • 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.

Other adverse events

Measure	Abatacept 30/10 mg/kg n=99 participants at risk 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 n=99 participants at risk 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 n=99 participants at risk；n=100 participants at risk 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
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	30.3% 30/99 • 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.	29.3% 29/99 • 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.	32.3% 32/99 • 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.
Infections and infestations GASTROENTERITIS	9.1% 9/99 • 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.	7.1% 7/99 • 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.	3.0% 3/99 • 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.
Infections and infestations URINARY TRACT INFECTION	9.1% 9/99 • 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.	10.1% 10/99 • 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.	17.2% 17/99 • 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.
Infections and infestations BRONCHITIS	7.1% 7/99 • 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.	8.1% 8/99 • 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.	11.1% 11/99 • 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.
Infections and infestations NASOPHARYNGITIS	6.1% 6/99 • 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.	11.1% 11/99 • 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.	7.1% 7/99 • 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.
Infections and infestations ORAL CANDIDIASIS	6.1% 6/99 • 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.	2.0% 2/99 • 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.	7.1% 7/99 • 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.
Infections and infestations HERPES ZOSTER	5.1% 5/99 • 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.	6.1% 6/99 • 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.	2.0% 2/99 • 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.
Infections and infestations ORAL HERPES	2.0% 2/99 • 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.	6.1% 6/99 • 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.	2.0% 2/99 • 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.
General disorders PYREXIA	13.1% 13/99 • 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.	6.1% 6/99 • 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.	5.1% 5/99 • 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.
General disorders OEDEMA PERIPHERAL	12.1% 12/99 • 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.	9.1% 9/99 • 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.	16.2% 16/99 • 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.
General disorders CHEST PAIN	6.1% 6/99 • 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.	3.0% 3/99 • 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.	3.0% 3/99 • 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.
General disorders ASTHENIA	5.1% 5/99 • 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.	2.0% 2/99 • 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.	4.0% 4/99 • 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.
General disorders FATIGUE	5.1% 5/99 • 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.	4.0% 4/99 • 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.	4.0% 4/99 • 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.
Gastrointestinal disorders DIARRHOEA	13.1% 13/99 • 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.	11.1% 11/99 • 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.	19.2% 19/99 • 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.
Gastrointestinal disorders NAUSEA	10.1% 10/99 • 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.	8.1% 8/99 • 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.	7.1% 7/99 • 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.
Gastrointestinal disorders ABDOMINAL PAIN	5.1% 5/99 • 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.	5.1% 5/99 • 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.	6.1% 6/99 • 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.
Gastrointestinal disorders VOMITING	5.1% 5/99 • 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.	5.1% 5/99 • 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.	8.1% 8/99 • 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.
Gastrointestinal disorders MOUTH ULCERATION	4.0% 4/99 • 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.	2.0% 2/99 • 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.	5.1% 5/99 • 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.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	3.0% 3/99 • 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.	6.1% 6/99 • 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.	4.0% 4/99 • 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.
Gastrointestinal disorders DYSPEPSIA	3.0% 3/99 • 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.	5.1% 5/99 • 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.	2.0% 2/99 • 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.
Gastrointestinal disorders GASTRITIS	3.0% 3/99 • 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.	3.0% 3/99 • 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.	6.1% 6/99 • 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.
Musculoskeletal and connective tissue disorders BACK PAIN	12.1% 12/99 • 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.	7.1% 7/99 • 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.	8.1% 8/99 • 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.
Musculoskeletal and connective tissue disorders ARTHRALGIA	9.1% 9/99 • 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.	7.1% 7/99 • 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.	17.2% 17/99 • 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.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	6.1% 6/99 • 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.	1.0% 1/99 • 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.	3.0% 3/99 • 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.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	5.1% 5/99 • 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.	5.1% 5/99 • 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.	8.1% 8/99 • 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.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	2.0% 2/99 • 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.	2.0% 2/99 • 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.	5.1% 5/99 • 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.
Musculoskeletal and connective tissue disorders MYALGIA	1.0% 1/99 • 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.	2.0% 2/99 • 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.	6.1% 6/99 • 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.
Nervous system disorders HEADACHE	21.2% 21/99 • 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.	11.1% 11/99 • 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.	15.2% 15/99 • 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.
Nervous system disorders DIZZINESS	7.1% 7/99 • 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.	5.1% 5/99 • 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.	4.0% 4/99 • 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.
Respiratory, thoracic and mediastinal disorders COUGH	8.1% 8/99 • 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.	6.1% 6/99 • 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.	15.2% 15/99 • 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.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	5.1% 5/99 • 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.	3.0% 3/99 • 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.	3.0% 3/99 • 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.
Skin and subcutaneous tissue disorders ACNE	8.1% 8/99 • 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.	7.1% 7/99 • 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.	4.0% 4/99 • 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.
Skin and subcutaneous tissue disorders ALOPECIA	4.0% 4/99 • 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.	4.0% 4/99 • 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.	7.1% 7/99 • 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.
Blood and lymphatic system disorders ANAEMIA	6.1% 6/99 • 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.	8.1% 8/99 • 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.	9.1% 9/99 • 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.
Blood and lymphatic system disorders LEUKOPENIA	6.1% 6/99 • 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.	1.0% 1/99 • 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.	5.1% 5/99 • 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.
Vascular disorders HYPERTENSION	9.1% 9/99 • 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.	9.1% 9/99 • 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.	7.1% 7/99 • 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.
Psychiatric disorders INSOMNIA	5.1% 5/99 • 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.	6.1% 6/99 • 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.	9.1% 9/99 • 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.
Metabolism and nutrition disorders HYPOKALAEMIA	2.0% 2/99 • 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.	4.0% 4/99 • 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.	6.1% 6/99 • 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.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	1.0% 1/99 • 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.	4.0% 4/99 • 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.	6.1% 6/99 • 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.
Eye disorders CONJUNCTIVITIS	0.00% 0/99 • 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.	2.0% 2/99 • 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.	8.1% 8/99 • 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.

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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
• Publication restrictions are in place

Restriction type: OTHER