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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00119678
• Collaborator: (none)
• Enrollment: 183
• Locations: 52
• Arms: 3
• Duration (Months): 38
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus	Drug: Abatacept; Drug: Placebo; Drug: Prednisone; Drug: Abatacept	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Abatacept + Prednisone Double Blind Period	Drug: Abatacept; Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months; Other Names: Orencia ; Drug: Prednisone; Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
Placebo Comparator: Placebo + Prednisone Double Blind Period	Drug: Placebo; Injectable, intravenous, 0 mg, every 28 days, 12 months; Drug: Prednisone; Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
Experimental: Abatacept Open Label	Drug: Abatacept; Injectable, intravenous, 10 mg/kg, every 28 days; Other Names: Orencia

Outcome Measures

Primary Outcome Measures

1. Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare [From start of corticosteroid taper to Day 365]

   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).

2. 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 [From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

   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.

3. OL; Number of Participants With Significant AEs of Special Interest [From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

   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.

4. OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count [From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

   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).

5. OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) [From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

   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.

6. 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 [From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

   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.

7. OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total) [From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

   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.

8. OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides [From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

   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.

9. OL; Number of Participants With MAs in Urinalysis [From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period]

   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.

Secondary Outcome Measures

1. DB; Number of Participants With a New SLE Flare During the Initial 6 Months [From start of corticosteroid taper to 6 months.]

   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).

2. DB; Total Number of New SLE Flares Each Participant Experienced [From start of corticosteroid taper to Day 365]

   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).

3. DB; Median Number of Days to the First Occurrence of a New SLE Flare [From start of corticosteroid taper to confirmation of disease flare or the end of double-blind period]

   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).

4. DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline [From start of study drug treatment to Day 365]

   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.

5. DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs [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]

   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.

6. DB; Number of Participants With Significant AEs of Special Interest [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]

   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.

7. DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count [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]

   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).

8. DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) [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]

   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.

9. DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine [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]

   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.

10. DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total) [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]

    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.

11. DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides [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]

    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.

12. DB; Number of Participants With MAs in Urinalysis [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]

    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.

13. DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings [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]

    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.

14. DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment [From Day 1 to Day 365]

    Electrochemiluminescence (ECL) immunoassay based on Meso Scale Discovery (MSD) technology was used to detect antibodies specific for CTLA4-T and for abatacept.

15. OL; Number of Participants With a New SLE Flare [From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.]

    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.

16. OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline [From start of study drug therapy in open-label period (Day 365) and on Day 729.]

    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.

17. OL; Total Number of BILAG A Flares Each Participant Experienced [From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.]

    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.

18. OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent [From start of study drug therapy in open-label period (Day 365), Day 393, 421, 449 and every 28 days thereafter till Day 729.]

    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.

19. OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment [After the first dose of open-label period]

    MSD technology was used to detect antibodies specific for CTLA4-T and for abatacept.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• participants must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit (arthritis)

• Stable dose of prednisone (<30mg) for at least one month

Exclusion Criteria:

• participants experiencing an active lupus flare in the kidney or central nervous systems

• Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study

• participants with active viral or bacterial infections

• participants with any other autoimmune disease as a main diagnosis

• Prior treatment with rituximab

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Arizona Arthritis Center	Tucson	Arizona	United States	85724
2	Office Of Geoffrey S. Dolan, Md	Long Beach	California	United States	90808
3	8737 Beverly Blvd.	Los Angeles	California	United States	90048
4	Denver Arthritis Clinic	Denver	Colorado	United States	80230
5	Cria Research	Ft. Lauderdale	Florida	United States	33334
6	The University Of Chicago	Chicago	Illinois	United States	60637
7	Kentuckiana Center For Better Bone And Joint Health	Louisville	Kentucky	United States	40202
8	Kelly, Timothy	Las Vegas	Nevada	United States	89128
9	Suny Downstate Medical Center	Brooklyn	New York	United States	11203
10	Columbia University Medical Center	New York	New York	United States	10032
11	Ok Medical Research Foundations	Oklahoma City	Oklahoma	United States	73104
12	Texas Research Center	Sugarland	Texas	United States	77479
13	Local Institution	Cairns	Queensland	Australia	4870
14	Local Institution	Maroochydore	Queensland	Australia	4558
15	Local Institution	Clayton	Victoria	Australia	3168
16	Local Institution	Heidelberg	Victoria	Australia	3084
17	Local Institution	Malvern	Victoria	Australia	3144
18	Local Institution	Graz		Austria	8036
19	Local Institution	Bruxelles		Belgium	1200
20	Local Institution	Leuven		Belgium	3000
21	Local Institution	Goiania	Goias	Brazil	74050
22	Local Institution	Curitiba	Parana	Brazil	80060
23	Local Institution	Rio De Janeiro - Rj	Rio De Janeiro	Brazil	20551
24	Local Institution	Campinas	Sao Paulo	Brazil	13083
25	Local Institution	São Paulo	Sao Paulo	Brazil	04027
26	Local Institution	Sao Paulo		Brazil	01246
27	Local Institution	Sao Paulo		Brazil	04023900
28	Local Institution	Sao Paulo		Brazil	04233
29	Local Institution	Vancouver	British Columbia	Canada	V5Z 1L7
30	Local Institution	Winnipeg	Manitoba	Canada	R3A 1M4
31	Local Institution	Bordeaux Cedex		France	33076
32	Local Institution	Montpellier Cedex 5		France	34295
33	Local Institution	Paris Cedex 14		France	75679
34	Local Institution	Berlin		Germany	13125
35	Local Institution	Duesseldorf		Germany	40225
36	Local Institution	Freiburg		Germany	79106
37	Local Institution	Ferrara		Italy	44100
38	Local Institution	Seoul	Sungdong-Gu	Korea, Republic of	133-792
39	Local Institution	Seoul		Korea, Republic of	110-744
40	Local Institution	Seoul		Korea, Republic of	137-040
41	Local Institution	Seoul		Korea, Republic of	138-736
42	Local Institution	Mexico City	Distrito Federal	Mexico	06726
43	Local Institution	Morelia	Michioacan	Mexico	58070
44	Local Institution	Aguascalientes		Mexico	20000
45	Local Institution	Ponce		Puerto Rico	00716
46	Local Institution	Berea	Kwa Zulu Natal	South Africa	4001
47	Local Institution	Panorama	Western Cape	South Africa	7506
48	Local Institution	Kaohsiung		Taiwan	833
49	Local Institution	Taichung		Taiwan	407
50	Local Institution	Taipei		Taiwan	105
51	Local Institution	Taipei		Taiwan	11217
52	Local Institution	London	Greater London	United Kingdom	SE1 7EX

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT00119678
• Other Study ID Numbers: IM101-042
• First Posted: Jul 14, 2005
• Last Update Posted: Sep 22, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Bristol-Myers Squibb: SLE
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Prednisone; Abatacept

Study Results

Participant Flow

Pre-assignment Detail	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
Period Title: Double-blind Treatment Period
STARTED	110	0
COMPLETED	0	0
NOT COMPLETED	110	0

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 Participants	118	57	175
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	38.0 (12.76)	36.0	38.0
Sex: Female, Male (Count of Participants)
Female	104 88.1%	55 96.5%	159 90.9%
Male	14 11.9%	2 3.5%	16 9.1%
Race/Ethnicity, Customized (participants) [Number]
White	74 62.7%	39 68.4%	113 64.6%
Black/African American	12 10.2%	4 7%	16 9.1%
American Indian/Alaska Native	1 0.8%	0 0%	1 0.6%
Asian	28 23.7%	13 22.8%	41 23.4%
Other races	3 2.5%	1 1.8%	4 2.3%
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	68.630 (18.717)	69.000 (14.790)	68.750 (17.493)
Systemic Lupus International Collaborative Clinics/American College of Rheumatology(SLICC/ACC) score (participants) [Number]
Overall SLICC/ACR score 0	82 69.5%	38 66.7%	120 68.6%
Overall SLICC/ACR score 1	12 10.2%	11 19.3%	23 13.1%
Overall SLICC/ACR score 2	15 12.7%	5 8.8%	20 11.4%
Overall SLICC/ACR score >2	6 5.1%	1 1.8%	7 4%
Overall SLICC/ACR score unavailable	3 2.5%	2 3.5%	5 2.9%

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.
Measure Participants	118	57
Number [Participants]	94 79.7%	47 82.5%

2. 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.
Measure Participants	118	57
Number [Participants]	75 63.6%	36 63.2%

3. 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.
Measure Participants	118	57
None	24 20.3%	10 17.5%
1	47 39.8%	21 36.8%
2	21 17.8%	10 17.5%
>=3	17 14.4%	11 19.3%
Inception treatment failure	9 7.6%	5 8.8%

4. 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.
Measure Participants	118	57
Median (95% Confidence Interval) [Days]	107.0	92.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.7 to 1.5
	Parameter Dispersion	Type: Value:
	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.

5. 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.
Measure Participants	107	47
No change	101 85.6%	44 77.2%
Increased 1	3 2.5%	2 3.5%
Increased >1	3 2.5%	1 1.8%

6. 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.
Measure Participants	121	59
Deaths	0 0%	0 0%
AEs	110 93.2%	54 94.7%
SAEs	24 20.3%	4 7%
All AEs Leading to Discontinuation	10 8.5%	3 5.3%
Drug related AEs	59 50%	28 49.1%

7. 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.
Measure Participants	121	59
Infections	71 60.2%	38 66.7%
Malignant neoplasms	1 0.8%	0 0%
Pre-specified autoimmune disorders	4 3.4%	2 3.5%
Acute-infusional AEs	5 4.2%	5 8.8%
Peri-infusional AEs	27 22.9%	13 22.8%

8. 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.
Measure Participants	120	58
Hemoglobin (n = 120, 58)	1 0.8%	1 1.8%
Hematocrit (n=120, 58)	1 0.8%	1 1.8%
Erythrocytes (n=120, 58)	1 0.8%	1 1.8%
Platelet count (n= 118, 58)	3 2.5%	0 0%

9. 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.
Measure Participants	120	59
Leukocytes (n = 120, 58)	26 22%	11 19.3%
Neutrophils+bands (absolute) (n = 120, 59)	8 6.8%	2 3.5%
Lymphocytes (absolute) (n = 120, 59)	46 39%	30 52.6%
Monocytes (absolute) (n = 120, 59)	1 0.8%	0 0%
Basophils (absolute) (n = 120, 59)	0 0%	0 0%
Eosinophils (absolute) (n = 120, 59)	6 5.1%	2 3.5%

10. 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.
Measure Participants	120	59
ALP (n = 120, 59)	2 1.7%	0 0%
AST (n = 120, 59)	3 2.5%	0 0%
ALT (n = 120, 59)	2 1.7%	0 0%
GGT (n = 120, 59)	3 2.5%	3 5.3%
Bilirubin (total) (n = 120, 59)	0 0%	0 0%
BUN (n = 120, 59)	4 3.4%	3 5.3%
Creatinine (n = 120, 59)	6 5.1%	4 7%

11. 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.
Measure Participants	120	59
Sodium (serum) (n = 120, 59)	1 0.8%	0 0%
Potassium (serum) (n = 120, 59)	1 0.8%	1 1.8%
Chloride (serum) (n = 120, 59)	0 0%	0 0%
Calcium (total) (n= 120, 59)	0 0%	0 0%
Protein (total) (n = 120, 59)	1 0.8%	0 0%

12. 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.
Measure Participants	120	59
Glucose (serum) (n = 120, 59)	27 22.9%	10 17.5%
Glucose, fasting (n = 77, 37)	5 4.2%	1 1.8%
Albumin (n = 120, 59)	4 3.4%	1 1.8%
Cholesterol (total) (n = 118, 58)	0 0%	0 0%
Triglycerides (n = 75, 36)	0 0%	0 0%
Triglycerides (fasting) (n = 64, 34)	0 0%	0 0%

13. 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.
Measure Participants	120	58
Protein (n = 120, 58)	15 12.7%	9 15.8%
Glucose (n = 120, 58)	1 0.8%	2 3.5%
Blood (n = 120, 58)	39 33.1%	18 31.6%
Leukocyte esterase (n = 107, 51)	23 19.5%	8 14%
RBC (n = 107, 55)	38 32.2%	16 28.1%
WBC (n = 115, 54)	61 51.7%	26 45.6%
Protein, 24 hours (n = 89, 40)	4 3.4%	1 1.8%
GFR (n = 120, 59)	7 5.9%	4 7%
Protein/creatinine ratio (n = 119, 58)	11 9.3%	4 7%

14. 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.
Measure Participants	0	0

15. 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).
Measure Participants	110
Deaths	1 0.8%
AEs	97 82.2%
SAEs	21 17.8%
All AEs Leading to Discontinuation	3 2.5%
Drug related AEs	49 41.5%
Drug related SAEs	11 9.3%

16. 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).
Measure Participants	110
Infections	82 69.5%
Malignant neoplasms	1 0.8%
Pre-specified autoimmune disorders	4 3.4%
Acute-infusional AEs	3 2.5%
Peri-infusional AEs	15 12.7%

17. 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).
Measure Participants	110
Hemoglobin (n = 110)	2 1.7%
Hematocrit (n = 110)	3 2.5%
Erythrocytes (n = 110)	2 1.7%
Platelet count (n = 108)	3 2.5%

18. 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).
Measure Participants	110
Leukocytes	18 15.3%
Neutrophils+bands (absolute)	6 5.1%
Lymphocytes (absolute)	32 27.1%
Monocytes (absolute)	0 0%
Basophils (absolute)	0 0%
Eosinophils (absolute)	3 2.5%

19. 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).
Measure Participants	110
ALP	0 0%
AST	3 2.5%
ALT	4 3.4%
GGT	6 5.1%
Bilirubin (total)	0 0%
BUN	3 2.5%
Creatinine	7 5.9%

20. 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).
Measure Participants	110
Sodium (serum)	0 0%
Potassium (serum)	7 5.9%
Chloride (serum)	0 0%
Calcium (total)	1 0.8%
Protein (total)	4 3.4%

21. 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).
Measure Participants	110
Glucose (serum) (n = 110)	21 17.8%
Glucose (fasting serum) (n = 55)	6 5.1%
Albumin (n = 110)	6 5.1%
Cholesterol (total) (n = 15)	0 0%
Triglycerides (n = 10)	0 0%
Triglycerides (fasting) (n = 9)	0 0%

22. 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).
Measure Participants	110
Protein (n = 110)	12 10.2%
Glucose (n= 110)	0 0%
Blood (n = 110)	41 34.7%
Leukocyte esterase (n = 104)	28 23.7%
WBC (n = 105)	57 48.3%
RBC (n = 101)	35 29.7%
GFR (n = 110)	9 7.6%
Protein/creatinine ratio (n = 109)	10 8.5%

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.
Measure Participants	121
Number [participants]	2 1.7%

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).
Measure Participants	0

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).
Measure Participants	0

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.
Measure Participants	0

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).
Measure Participants	0

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).
Measure Participants	108
Number [participants]	30 25.4%

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.
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Abatacept		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/121 (19.8%)		4/59 (6.8%)
Blood and lymphatic system disorders
ANAEMIA	1/121 (0.8%)		0/59 (0%)
Cardiac disorders
PERICARDITIS	2/121 (1.7%)		0/59 (0%)
Gastrointestinal disorders
HAEMATEMESIS	1/121 (0.8%)		0/59 (0%)
GASTRIC ULCER	1/121 (0.8%)		0/59 (0%)
ABDOMINAL PAIN	1/121 (0.8%)		0/59 (0%)
PERITONITIS LUPUS	0/121 (0%)		1/59 (1.7%)
General disorders
PYREXIA	3/121 (2.5%)		0/59 (0%)
CHEST PAIN	1/121 (0.8%)		0/59 (0%)
FACE OEDEMA	1/121 (0.8%)		0/59 (0%)
OEDEMA PERIPHERAL	1/121 (0.8%)		0/59 (0%)
Immune system disorders
HYPERSENSITIVITY	1/121 (0.8%)		0/59 (0%)
DRUG HYPERSENSITIVITY	1/121 (0.8%)		0/59 (0%)
Infections and infestations
BRONCHITIS	1/121 (0.8%)		0/59 (0%)
DIVERTICULITIS	1/121 (0.8%)		0/59 (0%)
GASTROENTERITIS	1/121 (0.8%)		0/59 (0%)
BRONCHOPNEUMONIA	0/121 (0%)		1/59 (1.7%)
Injury, poisoning and procedural complications
ANKLE FRACTURE	1/121 (0.8%)		0/59 (0%)
GUN SHOT WOUND	1/121 (0.8%)		0/59 (0%)
Metabolism and nutrition disorders
DEHYDRATION	1/121 (0.8%)		0/59 (0%)
Musculoskeletal and connective tissue disorders
ARTHRITIS	1/121 (0.8%)		0/59 (0%)
COSTOCHONDRITIS	1/121 (0.8%)		0/59 (0%)
MUSCULOSKELETAL CHEST PAIN	1/121 (0.8%)		0/59 (0%)
SYSTEMIC LUPUS ERYTHEMATOSUS	3/121 (2.5%)		1/59 (1.7%)
Nervous system disorders
HEADACHE	0/121 (0%)		1/59 (1.7%)
POLYNEUROPATHY	1/121 (0.8%)		0/59 (0%)
ACUTE POLYNEUROPATHY	1/121 (0.8%)		0/59 (0%)
Psychiatric disorders
DEPRESSION	1/121 (0.8%)		0/59 (0%)
PSYCHOTIC DISORDER	1/121 (0.8%)		1/59 (1.7%)
Renal and urinary disorders
LUPUS NEPHRITIS	1/121 (0.8%)		0/59 (0%)
GLOMERULONEPHRITIS	1/121 (0.8%)		0/59 (0%)
MESANGIOPROLIFERATIVE GLOMERULONEPHRITIS	1/121 (0.8%)		0/59 (0%)
Respiratory, thoracic and mediastinal disorders
ALVEOLITIS	1/121 (0.8%)		0/59 (0%)
PLEURAL EFFUSION	1/121 (0.8%)		0/59 (0%)
Skin and subcutaneous tissue disorders
ANGIOEDEMA	0/121 (0%)		1/59 (1.7%)
Vascular disorders
LUPUS VASCULITIS	0/121 (0%)		1/59 (1.7%)
Other (Not Including Serious) Adverse Events
	Abatacept		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	90/121 (74.4%)		41/59 (69.5%)
Cardiac disorders
PALPITATIONS	2/121 (1.7%)		4/59 (6.8%)
Gastrointestinal disorders
NAUSEA	12/121 (9.9%)		4/59 (6.8%)
DIARRHOEA	14/121 (11.6%)		4/59 (6.8%)
CONSTIPATION	2/121 (1.7%)		3/59 (5.1%)
ABDOMINAL PAIN	11/121 (9.1%)		0/59 (0%)
ABDOMINAL PAIN UPPER	7/121 (5.8%)		5/59 (8.5%)
General disorders
CHEST PAIN	7/121 (5.8%)		4/59 (6.8%)
Infections and infestations
INFLUENZA	7/121 (5.8%)		3/59 (5.1%)
SINUSITIS	8/121 (6.6%)		4/59 (6.8%)
BRONCHITIS	7/121 (5.8%)		4/59 (6.8%)
PHARYNGITIS	3/121 (2.5%)		4/59 (6.8%)
GASTROENTERITIS	7/121 (5.8%)		2/59 (3.4%)
NASOPHARYNGITIS	3/121 (2.5%)		7/59 (11.9%)
URINARY TRACT INFECTION	13/121 (10.7%)		5/59 (8.5%)
UPPER RESPIRATORY TRACT INFECTION	25/121 (20.7%)		9/59 (15.3%)
Musculoskeletal and connective tissue disorders
BACK PAIN	15/121 (12.4%)		5/59 (8.5%)
ARTHRALGIA	11/121 (9.1%)		4/59 (6.8%)
MUSCLE SPASMS	1/121 (0.8%)		4/59 (6.8%)
Nervous system disorders
HEADACHE	25/121 (20.7%)		10/59 (16.9%)
DIZZINESS	6/121 (5%)		5/59 (8.5%)
Psychiatric disorders
INSOMNIA	10/121 (8.3%)		5/59 (8.5%)
DEPRESSION	7/121 (5.8%)		3/59 (5.1%)
Respiratory, thoracic and mediastinal disorders
COUGH	10/121 (8.3%)		5/59 (8.5%)
NASAL CONGESTION	3/121 (2.5%)		3/59 (5.1%)
PHARYNGOLARYNGEAL PAIN	12/121 (9.9%)		2/59 (3.4%)
Skin and subcutaneous tissue disorders
ACNE	7/121 (5.8%)		0/59 (0%)
RASH	4/121 (3.3%)		3/59 (5.1%)
PRURITUS	4/121 (3.3%)		3/59 (5.1%)
Vascular disorders
HYPERTENSION	4/121 (3.3%)		3/59 (5.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.