Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone

• ClinicalTrials.gov Identifier: NCT00119678
• Recruitment Status: Completed
• First Posted: July 14, 2005
• Results First Posted: May 9, 2011
• Last Update Posted: September 22, 2014
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Systemic Lupus Erythematosus
• Interventions: Drug: Abatacept; Drug: Placebo; Drug: Prednisone
• Enrollment: 183

Participant Flow

Recruitment Details
Pre-assignment Details	263 participants were enrolled in this study and 80 were excluded from the trial due to screening failure. Of the 183 randomized, 3 were not treated and 5 were treated but excluded due to site closure.

Arm/Group Title	Abatacept	Placebo
Arm/Group Description	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Period Title: Double-blind Treatment Period
Started	122	61
RANDOMIZED AND TREATED	121	59
RANDOMIZED,TREATED, AND ANALYZED	118	57
Completed	81	35
Not Completed	41	26
Reason Not Completed
Death	1	0
Adverse Event	7	1
Lack of Efficacy	21	12
Lost to Follow-up	1	2
Participant withdrew consent	4	4
Participants not meeting study criteria	0	1
Poor/Non-compliance	3	0
Pregnancy	0	2
Not treated	1	2
Site closed due to non-compliance	3	2
Period Title: Open-label Treatment Period
Started	110 [1]	0
Completed	0	0
Not Completed	110	0
Reason Not Completed
Death	1	0
Adverse Event	3	0
Lack of Efficacy	9	0
Lost to Follow-up	3	0
Participant withdrew consent	4	0
Participants not meeting study criteria	2	0
Pregnancy	1	0
Administrative reasons by sponsor	87	0
[1] Number of participants treated

Baseline Characteristics

Arm/Group Title		Abatacept	Placebo	Total
Arm/Group Description		Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Total of all reporting groups
Overall Number of Baseline Participants		118	57	175
Baseline Analysis Population Description		[Not Specified]
Age, Continuous [1]; Median (Full Range); Unit of measure: Years
	Number Analyzed	118 participants	57 participants	175 participants
		38.0; (18.0 to 71.0)	36.0; (19.0 to 65.0)	38.0; (18.0 to 71.0)
		[1] Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	118 participants	57 participants	175 participants
	Female	104 88.1%	55 96.5%	159 90.9%
	Male	14 11.9%	2 3.5%	16 9.1%
		[1] Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
Race/Ethnicity, Customized [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	118 participants	57 participants	175 participants
White		74	39	113
Black/African American		12	4	16
American Indian/Alaska Native		1	0	1
Asian		28	13	41
Other races		3	1	4
		[1] Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
Weight [1]; Mean (Standard Deviation); Unit of measure: Kilograms
	Number Analyzed	118 participants	57 participants	175 participants
		68.630 (18.717)	69.000 (14.790)	68.750 (17.493)
		[1] Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
Systemic Lupus International Collaborative Clinics/American College of Rheumatology(SLICC/ACC) score [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	118 participants	57 participants	175 participants
Overall SLICC/ACR score 0		82	38	120
Overall SLICC/ACR score 1		12	11	23
Overall SLICC/ACR score 2		15	5	20
Overall SLICC/ACR score >2		6	1	7
Overall SLICC/ACR score unavailable		3	2	5
		[1] Measure Description: SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.

Outcome Measures

1. Primary Outcome

Title	Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare
Description	SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved. Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).
Time Frame	From start of corticosteroid taper to Day 365

Outcome Measure Data

Analysis Population Description

All randomized and treated participants, grouped by the treatment randomized to (Intent to Treat [ITT]). Participants who were inception treatment failures were treated as having 1 new flare; participants who discontinued early without any new flares were treated as having 1 new flare.

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	118	57
Measure Type: Number; Unit of Measure: Participants
	94	47

2. Primary Outcome

Title	Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs
Description	AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to an AE were recorded. Drug-related AEs or SAEs: events with a relationship to the study therapy of certain; probable; possible; or missing.
Time Frame	From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: participants
Deaths	1
AEs	97
SAEs	21
All AEs Leading to Discontinuation	3
Drug related AEs	49
Drug related SAEs	11

3. Primary Outcome

Title	OL; Number of Participants With Significant AEs of Special Interest
Description	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, it was decided that AEs of particular importance were associated with the use of immunomodulatory agents. Number of participants with infections, malignant Neoplasms, pre-specified autoimmune disorders, acute-infusional AEs and peri-infusional AEs were recorded.
Time Frame	From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: participants
Infections	82
Malignant neoplasms	1
Pre-specified autoimmune disorders	4
Acute-infusional AEs	3
Peri-infusional AEs	15

4. Primary Outcome

Title	OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* lower limit of normal (LLN) or >1.5* upper limit of normal (ULN) (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).
Time Frame	From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where "not evaluable" was recorded for "high" values (hemoglobin, hematocrit, erythrocytes) and has been presented as "0". n = number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: participants
Hemoglobin (n = 110)	2
Hematocrit (n = 110)	3
Erythrocytes (n = 110)	2
Platelet count (n = 108)	3

5. Primary Outcome

Title	OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
Description	MMAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.
Time Frame	From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where "not evaluable" was recorded for either "low"(monocytes, basophils, eosinophils) or "high"(neutrophils) has been presented as "0".

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: participants
Leukocytes	18
Neutrophils+bands (absolute)	6
Lymphocytes (absolute)	32
Monocytes (absolute)	0
Basophils (absolute)	0
Eosinophils (absolute)	3

6. Primary Outcome

Title	OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.
Time Frame	From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period. Where "not evaluable" was recorded for "low" values (ALP, AST, ALT, GGT, bilirubin, BUN, creatinine) and has been presented as "0".

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: participants
ALP	0
AST	3
ALT	4
GGT	6
Bilirubin (total)	0
BUN	3
Creatinine	7

7. Primary Outcome

Title	OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95x LLN or >1.05x ULN (if pre-Rx<LLN, then <0.95x pre-Rx or >ULN. If pre-Rx >ULN, then >1.05x pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9x LLN or >1.1xULN (if pre-Rx <LLN, then <0.9xpre-Rx or >ULN. If pre-Rx >ULN, then >1.1xpre-Rx or <LLN; Calcium (total): <0.8xLLN or >1.2xULN (if pre-Rx <LLN, then <0.75x pre-Rx or >ULN. If pre-Rx >ULN, then >1.25x pre-Rx or <LLN.
Time Frame	From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: participants
Sodium (serum)	0
Potassium (serum)	7
Chloride (serum)	0
Calcium (total)	1
Protein (total)	4

8. Primary Outcome

Title	OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
Description	MAs are laboratory measurements marked as abnormal, as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dL or >220 mg/dL; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.
Time Frame	From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication. Where "not evaluable" was recorded for either "low" (cholesterol, triglycerides) or "high" (albumin) has been presented as "0". n = number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: participants
Glucose (serum) (n = 110)	21
Glucose (fasting serum) (n = 55)	6
Albumin (n = 110)	6
Cholesterol (total) (n = 15)	0
Triglycerides (n = 10)	0
Triglycerides (fasting) (n = 9)	0

9. Primary Outcome

Title	OL; Number of Participants With MAs in Urinalysis
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, red blood cells (RBC), white blood cells (WBC): >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; Glomerular filtration rate (GFR): <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.
Time Frame	From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period

Outcome Measure Data

Analysis Population Description

As treated analysis population: all treated participants who entered the OL period and received at least 1 dose of study medication. Where "not evaluable" was recorded for "low" (protein, glucose, blood, leukocyte esterase, RBC, WBC) or "high"(GFR) values and presented as "0". n=number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	110
Measure Type: Number; Unit of Measure: participants
Protein (n = 110)	12
Glucose (n= 110)	0
Blood (n = 110)	41
Leukocyte esterase (n = 104)	28
WBC (n = 105)	57
RBC (n = 101)	35
GFR (n = 110)	9
Protein/creatinine ratio (n = 109)	10

10. Secondary Outcome

Title	DB; Number of Participants With a New SLE Flare During the Initial 6 Months
Description	SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).
Time Frame	From start of corticosteroid taper to 6 months.

Outcome Measure Data

Analysis Population Description

All randomized and treated participants, grouped by the treatment randomized to (ITT).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	118	57
Measure Type: Number; Unit of Measure: Participants
	75	36

11. Secondary Outcome

Title	DB; Total Number of New SLE Flares Each Participant Experienced
Description	SLE flares scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of prednisone/prednisone-equivalent taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).
Time Frame	From start of corticosteroid taper to Day 365

Outcome Measure Data

Analysis Population Description

All randomized and treated participants, grouped by the treatment randomized to (ITT).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	118	57
Measure Type: Number; Unit of Measure: Participants
None	24	10
1	47	21
2	21	10
>=3	17	11
Inception treatment failure	9	5

12. Secondary Outcome

Title	DB; Median Number of Days to the First Occurrence of a New SLE Flare
Description	Elapsed days between start of corticosteroid taper & first day of flare.Scored using BILAG:A:presence of =>1 serious;B:more moderate;C:mild symptomatic;D:prior activity,no current symptoms;E:organ that has never been involved.Calculated based on change during previous 4 weeks (1=improving,2=staying same,3=worsening,4=new).New SLE flare:first BILAG 'A' or 'B' event adjudicated to be flare following resolution of entry flare and/or start of corticosteroid taper.Inception treatment failure included (entry flare did not subside by Day 57/participant discontinued double-blind period before Day 29).
Time Frame	From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period

Outcome Measure Data

Analysis Population Description

All randomized and treated participants, grouped by the treatment randomized to (ITT).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	118	57
Median (95% Confidence Interval); Unit of Measure: Days
	107.0; (81.0 to 125.0)	92.0; (58.0 to 150.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.7 to 1.5
	Estimation Comments	Cox proportional-hazards model was used to estimate the hazard ratio of abatacept versus placebo for SLE disease flare. The 95% two-sided confidence interval was provided for the hazard ratio for treatment.

13. Secondary Outcome

Title	DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline
Description	SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.
Time Frame	From start of study drug treatment to Day 365

Outcome Measure Data

Analysis Population Description

All randomized and treated participants who were available for analysis, grouped by the treatment randomized to (ITT).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	107	47
Measure Type: Number; Unit of Measure: participants
No change	101	44
Increased 1	3	2
Increased >1	3	1

14. Secondary Outcome

Title	DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs
Description	AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Drug-related AEs: events with a certain; probable; possible; or missing relationship to the study therapy. Participants who discontinued the study due to an AE were recorded.
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

All participants given study drug during the double-blind period ("As Treated"). The AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	121	59
Measure Type: Number; Unit of Measure: participants
Deaths	0	0
AEs	110	54
SAEs	24	4
All AEs Leading to Discontinuation	10	3
Drug related AEs	59	28

15. Secondary Outcome

Title	DB; Number of Participants With Significant AEs of Special Interest
Description	An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition (even if not caused by the study drug). For this study, AEs of special interest were associated with the use of immunomodulatory agents. Number of participants with infections, malignant neoplasms, pre-specified autoimmune disorders, acute infusional AEs and peri-infusional AEs were recorded.
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

All participants given study drug during the double-blind period ("As Treated").Participants grouped for randomized treatments, except where different treatment taken for entire double-blind period (which will instead be presented by first treatment actually received).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	121	59
Measure Type: Number; Unit of Measure: participants
Infections	71	38
Malignant neoplasms	1	0
Pre-specified autoimmune disorders	4	2
Acute-infusional AEs	5	5
Peri-infusional AEs	27	13

16. Secondary Outcome

Title	DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Hemoglobin: >3 g/dL decrease from pre-treatment (pre-Rx) value; hematocrit: <0.75* pre-Rx value; erythrocyte count: <0.75* pre-Rx value; platelet count: <0.67* LLN or >1.5* ULN (or, if pre-Rx value <LLN, then <0.5* pre-Rx value or <100000/mm^3).
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

All participants given study drug during the double-blind period (As Treated) where "not evaluable" was recorded for "high" values (hemoglobin, hematocrit and erythrocytes)has been presented as "0". n=number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	120	58
Measure Type: Number; Unit of Measure: participants
Hemoglobin (n = 120, 58)	1	1
Hematocrit (n=120, 58)	1	1
Erythrocytes (n=120, 58)	1	1
Platelet count (n= 118, 58)	3	0

17. Secondary Outcome

Title	DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Leukocytes: <0.75* LLN or >1.25* ULN (or, if pre-Rx value <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx value >ULN, then >1.2* pre-Rx or <LLN; Neutrophils+bands (absolute): <1.00* 10^3 cells/microliter (c/uL); Lymphocytes (absolute): <0.75* 10^3 c/uL or >7.50* 10^3 c/uL; Monocytes (absolute): >2000/mm^3; Basophils (absolute): >0.40* 10^3 c/uL; Eosinophils (absolute): >0.75* 10^3 c/uL.
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

All participants given study drug during the double-blind period ("As Treated") where "not evaluable" was recorded for either "low"(monocytes, basophils and eosinophils) or "high" values(neutrophils)has been presented as "0".n=number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	120	59
Measure Type: Number; Unit of Measure: participants
Leukocytes (n = 120, 58)	26	11
Neutrophils+bands (absolute) (n = 120, 59)	8	2
Lymphocytes (absolute) (n = 120, 59)	46	30
Monocytes (absolute) (n = 120, 59)	1	0
Basophils (absolute) (n = 120, 59)	0	0
Eosinophils (absolute) (n = 120, 59)	6	2

18. Secondary Outcome

Title	DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria. ALP, GGT: >2* ULN (if pre-Rx >ULN, then >3* pre-Rx); AST, ALT: >3* ULN (if pre-Rx >ULN, then >4* pre-Rx). Bilirubin (total): >2* ULN (if pre-Rx >ULN, then >4* pre-Rx), BUN:>2* pre-Rx; Creatinine:>1.5* pre-Rx.
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

All participants given study drug during the double-blind period ("As Treated") where "not evaluable" was recorded for "low" values (all parameters) and has been presented as "0". n=number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	120	59
Measure Type: Number; Unit of Measure: participants
ALP (n = 120, 59)	2	0
AST (n = 120, 59)	3	0
ALT (n = 120, 59)	2	0
GGT (n = 120, 59)	3	3
Bilirubin (total) (n = 120, 59)	0	0
BUN (n = 120, 59)	4	3
Creatinine (n = 120, 59)	6	4

19. Secondary Outcome

Title	DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)
Description	MAs are laboratory measurements marked as abnormal as per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Sodium (serum): <0.95* LLN or >1.05* ULN (if pre-Rx <LLN, then <0.95* pre-Rx or >ULN. If pre-Rx >ULN, then >1.05* pre-Rx or <LLN); Potassium (serum), Chloride (serum), protein (total): <0.9* LLN or >1.1* ULN (if pre-Rx <LLN, then <0.9* pre-Rx or >ULN. If pre-Rx >ULN, then >1.1* pre-Rx or <LLN; Calcium (total): <0.8* LLN or >1.2* ULN (if pre-Rx <LLN, then <0.75* pre-Rx or >ULN. If pre-Rx >ULN, then >1.25* pre-Rx or <LLN.
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

All participants given study drug during the double-blind period ("As Treated").n=number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	120	59
Measure Type: Number; Unit of Measure: participants
Sodium (serum) (n = 120, 59)	1	0
Potassium (serum) (n = 120, 59)	1	1
Chloride (serum) (n = 120, 59)	0	0
Calcium (total) (n= 120, 59)	0	0
Protein (total) (n = 120, 59)	1	0

20. Secondary Outcome

Title	DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify MA criteria, Glucose: <65 mg/dl or >220 mg/dl; Glucose (fasting serum): <0.8* LLN or >1.5 ULN (if pre-Rx <LLN, then <0.8* pre-Rx or >ULN. If pre-Rx >ULN, then >2.0* pre-Rx or <LLN; Albumin: <0.9* LLN (if pre-Rx <LLN, then <0.75 * pre-Rx); cholesterol (total): >2* pre-Rx; triglycerides: >=2.5* ULN, or if pre Rx>ULN then use >2.5* pre Rx; fasting triglycerides: >=2.0* ULN, or if pre Rx>ULN then use >2.0* pre Rx.
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

"All participants given study drug during the double-blind period ("As Treated") where "not evaluable" was recorded for either "low" or "high" values (albumin, cholesterol, triglycerides) has been presented as "0".n=number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	120	59
Measure Type: Number; Unit of Measure: participants
Glucose (serum) (n = 120, 59)	27	10
Glucose, fasting (n = 77, 37)	5	1
Albumin (n = 120, 59)	4	1
Cholesterol (total) (n = 118, 58)	0	0
Triglycerides (n = 75, 36)	0	0
Triglycerides (fasting) (n = 64, 34)	0	0

21. Secondary Outcome

Title	DB; Number of Participants With MAs in Urinalysis
Description	MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following definitions specify the criteria for MAs in urinalysis, Protein, glucose, blood, Leukocyte esterase, RBC, WBC: >=2+ (or, if value >=4, or if pre-Rx value = 0 or 0.5, then >= 2* pre-Rx, or if pre-Rx value =1, then >=3, or if pre-Rx = 2 or 3, then >=4); protein (24 hour urine): >1000 mg/24 hrs and >=2* pre-Rx; GFR: <=60 mL/min/1.73m^2 or > 15% change from baseline; Protein/creatinine ratio: > 100 mg/mmol.
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

All participants given study drug during the double-blind period ("As Treated") where "not evaluable" was recorded for "low" (protein, glucose, blood, leukocyte esterase, RBC, WBC) or "high" (GFR) values has been presented as "0". n=number of participants with evaluable results (each arm respectively).

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	120	58
Measure Type: Number; Unit of Measure: participants
Protein (n = 120, 58)	15	9
Glucose (n = 120, 58)	1	2
Blood (n = 120, 58)	39	18
Leukocyte esterase (n = 107, 51)	23	8
RBC (n = 107, 55)	38	16
WBC (n = 115, 54)	61	26
Protein, 24 hours (n = 89, 40)	4	1
GFR (n = 120, 59)	7	4
Protein/creatinine ratio (n = 119, 58)	11	4

22. Secondary Outcome

Title	DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings
Description	Vital signs assessments and physical examination were conducted throughout the study. Vital signs assessments included body temperature, respiratory rate, blood pressure (systolic and diastolic) and heart rate. The investigator used his/her clinical judgment to decide whether or not abnormalities in vital signs or physical examination were clinically meaningful.
Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier

Outcome Measure Data

Analysis Population Description

All participants given study drug during the double-blind period ("As Treated"). Significant vital signs and physical examination findings are reported in the AE tables. Symptoms related to lupus were collected in British Isles Lupus Assessment Group (BILAG) assessments.

Arm/Group Title	Abatacept	Placebo
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

23. Secondary Outcome

Title	DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
Description	Electrochemiluminescence (ECL) immunoassay based on Meso Scale Discovery (MSD) technology was used to detect antibodies specific for CTLA4-T and for abatacept.
Time Frame	From Day 1 to Day 365

Outcome Measure Data

Analysis Population Description

Participants who received abatacept and for whom baseline and at least one additional measurement during double-blind period were available.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed	121
Measure Type: Number; Unit of Measure: participants
	2

24. Secondary Outcome

Title	OL; Number of Participants With a New SLE Flare
Description	SLE flares scored using BILAG:A:presence of =>1 serious lupus features;B:more moderate features;C:mild symptomatic features;D:prior activity with no current symptoms due to active lupus;E:an organ that has never been involved.BILAG scores based on degrees of change in clinical features (1=improving,2=staying the same,3=worsening,4=new).New SLE flare means new BILAG A/B features in any organ system.Based on the recommendation of the Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.
Time Frame	From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

25. Secondary Outcome

Title	OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline
Description	SLICC/ACR damage index:measure of cumulative damage due to SLE.Damage=non-reversible change occurring since onset of lupus,ascertained by clinical assessment & present for =>6 months.Scores of SLICC/ACR index:1:single episode;2:repeated episodes at least 6 months apart.Change in score from baseline to 1 year presented as:no change,increase 1 (an increase in score of 1),increase >1 (an increase in score of >1).Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.
Time Frame	From start of study drug therapy in open-label period (Day 365) and on Day 729.

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

26. Secondary Outcome

Title	OL; Total Number of BILAG A Flares Each Participant Experienced
Description	Total number of BILAG A flares in any organ system after steroid tapering = new BILAG A features in any organ system. Scores defined as follows: None: participants with no BILAG A flare; 1: participants with 1 BILAG A flare or participants who discontinued without a new BILAG A flare were imputed as having one event. 2: participants with 2 BILAG A flares; 3 or >3: participants with 3 or more BILAG A flares.Based on recommendation of Data Monitoring Committee, open-label period terminated, as failed to meet primary outcome measure for double-blind period/increase in SAEs in abatacept group.
Time Frame	From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg). Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. BILAG A: presence of one or more serious features of lupus; BILAG B: more moderate features of the disease; BILAG C: mild symptomatic features; BILAG D: prior activity with no current symptoms due to active lupus; BILAG E: an organ that has never been involved.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

27. Secondary Outcome

Title	OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent
Description	Total exposure to glucocorticosteroid was measured by the total prednisone or prednisone equivalent AUC. Based on the recommendation of the Data Monitoring Committee, the open-label, long-term extension period was terminated by the sponsor, for failure to meet the primary outcome measure for the double-blind period and because of an increase in SAEs in the abatacept treatment group. As such, these data were not analyzed.
Time Frame	From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.

Outcome Measure Data

Analysis Population Description

As treated analysis population: All treated participants who entered the open-label period and received at least one dose of study medication during open-label period.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

28. Secondary Outcome

Title	OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
Description	MSD technology was used to detect antibodies specific for CTLA4-T and for abatacept.
Time Frame	After the first dose of open-label period

Outcome Measure Data

Analysis Population Description

Immunogenicity analysis population: participants who received abatacept and for whom baseline and at least one additional measurement during the open-label period were available.

Arm/Group Title	Abatacept
Arm/Group Description:	Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed	108
Measure Type: Number; Unit of Measure: participants
	30

Adverse Events

Time Frame	Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Abatacept	Placebo
Arm/Group Description	Participants were administered abatacept (10 mg/kg) IV over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.	Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for BILAG "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
All-Cause Mortality
	Abatacept	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Abatacept	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	24/121 (19.83%)	4/59 (6.78%)
Blood and lymphatic system disorders
ANAEMIA † 1	1/121 (0.83%)	0/59 (0.00%)
Cardiac disorders
PERICARDITIS † 1	2/121 (1.65%)	0/59 (0.00%)
Gastrointestinal disorders
HAEMATEMESIS † 1	1/121 (0.83%)	0/59 (0.00%)
GASTRIC ULCER † 1	1/121 (0.83%)	0/59 (0.00%)
ABDOMINAL PAIN † 1	1/121 (0.83%)	0/59 (0.00%)
PERITONITIS LUPUS † 1	0/121 (0.00%)	1/59 (1.69%)
General disorders
PYREXIA † 1	3/121 (2.48%)	0/59 (0.00%)
CHEST PAIN † 1	1/121 (0.83%)	0/59 (0.00%)
FACE OEDEMA † 1	1/121 (0.83%)	0/59 (0.00%)
OEDEMA PERIPHERAL † 1	1/121 (0.83%)	0/59 (0.00%)
Immune system disorders
HYPERSENSITIVITY † 1	1/121 (0.83%)	0/59 (0.00%)
DRUG HYPERSENSITIVITY † 1	1/121 (0.83%)	0/59 (0.00%)
Infections and infestations
BRONCHITIS † 1	1/121 (0.83%)	0/59 (0.00%)
DIVERTICULITIS † 1	1/121 (0.83%)	0/59 (0.00%)
GASTROENTERITIS † 1	1/121 (0.83%)	0/59 (0.00%)
BRONCHOPNEUMONIA † 1	0/121 (0.00%)	1/59 (1.69%)
Injury, poisoning and procedural complications
ANKLE FRACTURE † 1	1/121 (0.83%)	0/59 (0.00%)
GUN SHOT WOUND † 1	1/121 (0.83%)	0/59 (0.00%)
Metabolism and nutrition disorders
DEHYDRATION † 1	1/121 (0.83%)	0/59 (0.00%)
Musculoskeletal and connective tissue disorders
ARTHRITIS † 1	1/121 (0.83%)	0/59 (0.00%)
COSTOCHONDRITIS † 1	1/121 (0.83%)	0/59 (0.00%)
MUSCULOSKELETAL CHEST PAIN † 1	1/121 (0.83%)	0/59 (0.00%)
SYSTEMIC LUPUS ERYTHEMATOSUS † 1	3/121 (2.48%)	1/59 (1.69%)
Nervous system disorders
HEADACHE † 1	0/121 (0.00%)	1/59 (1.69%)
POLYNEUROPATHY † 1	1/121 (0.83%)	0/59 (0.00%)
ACUTE POLYNEUROPATHY † 1	1/121 (0.83%)	0/59 (0.00%)
Psychiatric disorders
DEPRESSION † 1	1/121 (0.83%)	0/59 (0.00%)
PSYCHOTIC DISORDER † 1	1/121 (0.83%)	1/59 (1.69%)
Renal and urinary disorders
LUPUS NEPHRITIS † 1	1/121 (0.83%)	0/59 (0.00%)
GLOMERULONEPHRITIS † 1	1/121 (0.83%)	0/59 (0.00%)
MESANGIOPROLIFERATIVE GLOMERULONEPHRITIS † 1	1/121 (0.83%)	0/59 (0.00%)
Respiratory, thoracic and mediastinal disorders
ALVEOLITIS † 1	1/121 (0.83%)	0/59 (0.00%)
PLEURAL EFFUSION † 1	1/121 (0.83%)	0/59 (0.00%)
Skin and subcutaneous tissue disorders
ANGIOEDEMA † 1	0/121 (0.00%)	1/59 (1.69%)
Vascular disorders
LUPUS VASCULITIS † 1	0/121 (0.00%)	1/59 (1.69%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 11.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Abatacept	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	90/121 (74.38%)	41/59 (69.49%)
Cardiac disorders
PALPITATIONS † 1	2/121 (1.65%)	4/59 (6.78%)
Gastrointestinal disorders
NAUSEA † 1	12/121 (9.92%)	4/59 (6.78%)
DIARRHOEA † 1	14/121 (11.57%)	4/59 (6.78%)
CONSTIPATION † 1	2/121 (1.65%)	3/59 (5.08%)
ABDOMINAL PAIN † 1	11/121 (9.09%)	0/59 (0.00%)
ABDOMINAL PAIN UPPER † 1	7/121 (5.79%)	5/59 (8.47%)
General disorders
CHEST PAIN † 1	7/121 (5.79%)	4/59 (6.78%)
Infections and infestations
INFLUENZA † 1	7/121 (5.79%)	3/59 (5.08%)
SINUSITIS † 1	8/121 (6.61%)	4/59 (6.78%)
BRONCHITIS † 1	7/121 (5.79%)	4/59 (6.78%)
PHARYNGITIS † 1	3/121 (2.48%)	4/59 (6.78%)
GASTROENTERITIS † 1	7/121 (5.79%)	2/59 (3.39%)
NASOPHARYNGITIS † 1	3/121 (2.48%)	7/59 (11.86%)
URINARY TRACT INFECTION † 1	13/121 (10.74%)	5/59 (8.47%)
UPPER RESPIRATORY TRACT INFECTION † 1	25/121 (20.66%)	9/59 (15.25%)
Musculoskeletal and connective tissue disorders
BACK PAIN † 1	15/121 (12.40%)	5/59 (8.47%)
ARTHRALGIA † 1	11/121 (9.09%)	4/59 (6.78%)
MUSCLE SPASMS † 1	1/121 (0.83%)	4/59 (6.78%)
Nervous system disorders
HEADACHE † 1	25/121 (20.66%)	10/59 (16.95%)
DIZZINESS † 1	6/121 (4.96%)	5/59 (8.47%)
Psychiatric disorders
INSOMNIA † 1	10/121 (8.26%)	5/59 (8.47%)
DEPRESSION † 1	7/121 (5.79%)	3/59 (5.08%)
Respiratory, thoracic and mediastinal disorders
COUGH † 1	10/121 (8.26%)	5/59 (8.47%)
NASAL CONGESTION † 1	3/121 (2.48%)	3/59 (5.08%)
PHARYNGOLARYNGEAL PAIN † 1	12/121 (9.92%)	2/59 (3.39%)
Skin and subcutaneous tissue disorders
ACNE † 1	7/121 (5.79%)	0/59 (0.00%)
RASH † 1	4/121 (3.31%)	3/59 (5.08%)
PRURITUS † 1	4/121 (3.31%)	3/59 (5.08%)
Vascular disorders
HYPERTENSION † 1	4/121 (3.31%)	3/59 (5.08%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 11.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Results Point of Contact

• Name/Title: BMS Study Director
• Organization: Bristol-Myers Squibb
• EMail: Clinical.Trials@bms.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.

Bandyopadhyay S, Connolly SE, Jabado O, Ye J, Kelly S, Maldonado MA, Westhovens R, Nash P, Merrill JT, Townsend RM. Identification of biomarkers of response to abatacept in patients with SLE using deconvolution of whole blood transcriptomic data from a phase IIb clinical trial. Lupus Sci Med. 2017 Jul 28;4(1):e000206. doi: 10.1136/lupus-2017-000206. eCollection 2017.

Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, Bae SC, Sigal L, Becker JC, Kelly S, Raghupathi K, Li T, Peng Y, Kinaszczuk M, Nash P. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Oct;62(10):3077-87. doi: 10.1002/art.27601.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00119678
• Other Study ID Numbers: IM101-042
• First Submitted: June 30, 2005
• First Posted: July 14, 2005
• Results First Submitted: January 10, 2011
• Results First Posted: May 9, 2011
• Last Update Posted: September 22, 2014