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

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Systemic Lupus Erythematosus
Interventions Drug: Abatacept
Drug: Placebo
Drug: Prednisone
Enrollment 183
Recruitment Details  
Pre-assignment Details 263 participants were enrolled in this study and 80 were excluded from the trial due to screening failure. Of the 183 randomized, 3 were not treated and 5 were treated but excluded due to site closure.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued. Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Period Title: Double-blind Treatment Period
Started 122 61
RANDOMIZED AND TREATED 121 59
RANDOMIZED,TREATED, AND ANALYZED 118 57
Completed 81 35
Not Completed 41 26
Reason Not Completed
Death             1             0
Adverse Event             7             1
Lack of Efficacy             21             12
Lost to Follow-up             1             2
Participant withdrew consent             4             4
Participants not meeting study criteria             0             1
Poor/Non-compliance             3             0
Pregnancy             0             2
Not treated             1             2
Site closed due to non-compliance             3             2
Period Title: Open-label Treatment Period
Started 110 [1] 0
Completed 0 0
Not Completed 110 0
Reason Not Completed
Death             1             0
Adverse Event             3             0
Lack of Efficacy             9             0
Lost to Follow-up             3             0
Participant withdrew consent             4             0
Participants not meeting study criteria             2             0
Pregnancy             1             0
Administrative reasons by sponsor             87             0
[1]
Number of participants treated
Arm/Group Title Abatacept Placebo Total
Hide Arm/Group Description Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued. Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued. Total of all reporting groups
Overall Number of Baseline Participants 118 57 175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 118 participants 57 participants 175 participants
38.0
(18.0 to 71.0)
36.0
(19.0 to 65.0)
38.0
(18.0 to 71.0)
[1]
Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 57 participants 175 participants
Female
104
  88.1%
55
  96.5%
159
  90.9%
Male
14
  11.9%
2
   3.5%
16
   9.1%
[1]
Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 118 participants 57 participants 175 participants
White 74 39 113
Black/African American 12 4 16
American Indian/Alaska Native 1 0 1
Asian 28 13 41
Other races 3 1 4
[1]
Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 118 participants 57 participants 175 participants
68.630  (18.717) 69.000  (14.790) 68.750  (17.493)
[1]
Measure Description: 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
Systemic Lupus International Collaborative Clinics/American College of Rheumatology(SLICC/ACC) score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 118 participants 57 participants 175 participants
Overall SLICC/ACR score 0 82 38 120
Overall SLICC/ACR score 1 12 11 23
Overall SLICC/ACR score 2 15 5 20
Overall SLICC/ACR score >2 6 1 7
Overall SLICC/ACR score unavailable 3 2 5
[1]
Measure Description: SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity. 183 participants were randomized, 3 were not treated and 5 were treated but excluded due to site closure. Thus, Abatacept group n=118 and Placebo group n=57.
1.Primary Outcome
Title Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 118 57
Measure Type: Number
Unit of Measure: Participants
94 47
2.Primary Outcome
Title Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
Deaths 1
AEs 97
SAEs 21
All AEs Leading to Discontinuation 3
Drug related AEs 49
Drug related SAEs 11
3.Primary Outcome
Title OL; Number of Participants With Significant AEs of Special Interest
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
Infections 82
Malignant neoplasms 1
Pre-specified autoimmune disorders 4
Acute-infusional AEs 3
Peri-infusional AEs 15
4.Primary Outcome
Title OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
Hemoglobin (n = 110) 2
Hematocrit (n = 110) 3
Erythrocytes (n = 110) 2
Platelet count (n = 108) 3
5.Primary Outcome
Title OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
Leukocytes 18
Neutrophils+bands (absolute) 6
Lymphocytes (absolute) 32
Monocytes (absolute) 0
Basophils (absolute) 0
Eosinophils (absolute) 3
6.Primary Outcome
Title OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
ALP 0
AST 3
ALT 4
GGT 6
Bilirubin (total) 0
BUN 3
Creatinine 7
7.Primary Outcome
Title OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
Sodium (serum) 0
Potassium (serum) 7
Chloride (serum) 0
Calcium (total) 1
Protein (total) 4
8.Primary Outcome
Title OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
Glucose (serum) (n = 110) 21
Glucose (fasting serum) (n = 55) 6
Albumin (n = 110) 6
Cholesterol (total) (n = 15) 0
Triglycerides (n = 10) 0
Triglycerides (fasting) (n = 9) 0
9.Primary Outcome
Title OL; Number of Participants With MAs in Urinalysis
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: participants
Protein (n = 110) 12
Glucose (n= 110) 0
Blood (n = 110) 41
Leukocyte esterase (n = 104) 28
WBC (n = 105) 57
RBC (n = 101) 35
GFR (n = 110) 9
Protein/creatinine ratio (n = 109) 10
10.Secondary Outcome
Title DB; Number of Participants With a New SLE Flare During the Initial 6 Months
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants, grouped by the treatment randomized to (ITT).
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 118 57
Measure Type: Number
Unit of Measure: Participants
75 36
11.Secondary Outcome
Title DB; Total Number of New SLE Flares Each Participant Experienced
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants, grouped by the treatment randomized to (ITT).
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 118 57
Measure Type: Number
Unit of Measure: Participants
None 24 10
1 47 21
2 21 10
>=3 17 11
Inception treatment failure 9 5
12.Secondary Outcome
Title DB; Median Number of Days to the First Occurrence of a New SLE Flare
Hide 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
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Hide Analysis Population Description
All randomized and treated participants, grouped by the treatment randomized to (ITT).
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 118 57
Median (95% Confidence Interval)
Unit of Measure: Days
107.0
(81.0 to 125.0)
92.0
(58.0 to 150.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.7 to 1.5
Estimation Comments Cox proportional-hazards model was used to estimate the hazard ratio of abatacept versus placebo for SLE disease flare. The 95% two-sided confidence interval was provided for the hazard ratio for treatment.
13.Secondary Outcome
Title DB; Number of Participants With a Change in the SLICC/ACR Damage Index at 1 Year Compared to Baseline
Hide Description SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 48, and increasing score indicates increasing disease severity.
Time Frame From start of study drug treatment to Day 365
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Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 107 47
Measure Type: Number
Unit of Measure: participants
No change 101 44
Increased 1 3 2
Increased >1 3 1
14.Secondary Outcome
Title DB; Number of Participants Who Died, Experienced AEs, Other SAEs or Discontinuations Due to AEs, Drug Related AEs
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 121 59
Measure Type: Number
Unit of Measure: participants
Deaths 0 0
AEs 110 54
SAEs 24 4
All AEs Leading to Discontinuation 10 3
Drug related AEs 59 28
15.Secondary Outcome
Title DB; Number of Participants With Significant AEs of Special Interest
Hide 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
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Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 121 59
Measure Type: Number
Unit of Measure: participants
Infections 71 38
Malignant neoplasms 1 0
Pre-specified autoimmune disorders 4 2
Acute-infusional AEs 5 5
Peri-infusional AEs 27 13
16.Secondary Outcome
Title DB; Number of Participants With MAs in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count
Hide 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
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Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 120 58
Measure Type: Number
Unit of Measure: participants
Hemoglobin (n = 120, 58) 1 1
Hematocrit (n=120, 58) 1 1
Erythrocytes (n=120, 58) 1 1
Platelet count (n= 118, 58) 3 0
17.Secondary Outcome
Title DB; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 120 59
Measure Type: Number
Unit of Measure: participants
Leukocytes (n = 120, 58) 26 11
Neutrophils+bands (absolute) (n = 120, 59) 8 2
Lymphocytes (absolute) (n = 120, 59) 46 30
Monocytes (absolute) (n = 120, 59) 1 0
Basophils (absolute) (n = 120, 59) 0 0
Eosinophils (absolute) (n = 120, 59) 6 2
18.Secondary Outcome
Title DB: Number of Participants With MAs in Serum Chemistry: ALP, AST, ALT, GGT, Bilirubin (Total), BUN and Creatinine
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 120 59
Measure Type: Number
Unit of Measure: participants
ALP (n = 120, 59) 2 0
AST (n = 120, 59) 3 0
ALT (n = 120, 59) 2 0
GGT (n = 120, 59) 3 3
Bilirubin (total) (n = 120, 59) 0 0
BUN (n = 120, 59) 4 3
Creatinine (n = 120, 59) 6 4
19.Secondary Outcome
Title DB; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total),Protein (Total)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 120 59
Measure Type: Number
Unit of Measure: participants
Sodium (serum) (n = 120, 59) 1 0
Potassium (serum) (n = 120, 59) 1 1
Chloride (serum) (n = 120, 59) 0 0
Calcium (total) (n= 120, 59) 0 0
Protein (total) (n = 120, 59) 1 0
20.Secondary Outcome
Title DB; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 120 59
Measure Type: Number
Unit of Measure: participants
Glucose (serum) (n = 120, 59) 27 10
Glucose, fasting (n = 77, 37) 5 1
Albumin (n = 120, 59) 4 1
Cholesterol (total) (n = 118, 58) 0 0
Triglycerides (n = 75, 36) 0 0
Triglycerides (fasting) (n = 64, 34) 0 0
21.Secondary Outcome
Title DB; Number of Participants With MAs in Urinalysis
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 120 58
Measure Type: Number
Unit of Measure: participants
Protein (n = 120, 58) 15 9
Glucose (n = 120, 58) 1 2
Blood (n = 120, 58) 39 18
Leukocyte esterase (n = 107, 51) 23 8
RBC (n = 107, 55) 38 16
WBC (n = 115, 54) 61 26
Protein, 24 hours (n = 89, 40) 4 1
GFR (n = 120, 59) 7 4
Protein/creatinine ratio (n = 119, 58) 11 4
22.Secondary Outcome
Title DB; Number of Participants With Clinically Significant Abnormal Vital Signs and/or Physical Examination Findings
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title DB; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
Overall Number of Participants Analyzed 121
Measure Type: Number
Unit of Measure: participants
2
24.Secondary Outcome
Title OL; Number of Participants With a New SLE Flare
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title OL; Number of Participants With a Change in the SLICC/ACR Damage Index at Year 2 Compared to Baseline
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title OL; Total Number of BILAG A Flares Each Participant Experienced
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg). Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. BILAG A: presence of one or more serious features of lupus; BILAG B: more moderate features of the disease; BILAG C: mild symptomatic features; BILAG D: prior activity with no current symptoms due to active lupus; BILAG E: an organ that has never been involved.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title OL; Area Under the Curve (AUC) for Prednisone or Prednisone Equivalent
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
28.Secondary Outcome
Title OL; Number of Participants With Antibodies Specific for CTLA4-T and Abatacept, Following Abatacept Treatment
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: participants
30
Time Frame Events recorded at each participant encounter, from start of study drug therapy up to Day 337, including up to 56 days after the last dose or up to the first dose of open-label, whichever occurred earlier.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description Participants were administered abatacept (10 mg/kg) IV over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) "C" or "D" status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued. Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
All-Cause Mortality
Abatacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   24/121 (19.83%)   4/59 (6.78%) 
Blood and lymphatic system disorders     
ANAEMIA  1  1/121 (0.83%)  0/59 (0.00%) 
Cardiac disorders     
PERICARDITIS  1  2/121 (1.65%)  0/59 (0.00%) 
Gastrointestinal disorders     
HAEMATEMESIS  1  1/121 (0.83%)  0/59 (0.00%) 
GASTRIC ULCER  1  1/121 (0.83%)  0/59 (0.00%) 
ABDOMINAL PAIN  1  1/121 (0.83%)  0/59 (0.00%) 
PERITONITIS LUPUS  1  0/121 (0.00%)  1/59 (1.69%) 
General disorders     
PYREXIA  1  3/121 (2.48%)  0/59 (0.00%) 
CHEST PAIN  1  1/121 (0.83%)  0/59 (0.00%) 
FACE OEDEMA  1  1/121 (0.83%)  0/59 (0.00%) 
OEDEMA PERIPHERAL  1  1/121 (0.83%)  0/59 (0.00%) 
Immune system disorders     
HYPERSENSITIVITY  1  1/121 (0.83%)  0/59 (0.00%) 
DRUG HYPERSENSITIVITY  1  1/121 (0.83%)  0/59 (0.00%) 
Infections and infestations     
BRONCHITIS  1  1/121 (0.83%)  0/59 (0.00%) 
DIVERTICULITIS  1  1/121 (0.83%)  0/59 (0.00%) 
GASTROENTERITIS  1  1/121 (0.83%)  0/59 (0.00%) 
BRONCHOPNEUMONIA  1  0/121 (0.00%)  1/59 (1.69%) 
Injury, poisoning and procedural complications     
ANKLE FRACTURE  1  1/121 (0.83%)  0/59 (0.00%) 
GUN SHOT WOUND  1  1/121 (0.83%)  0/59 (0.00%) 
Metabolism and nutrition disorders     
DEHYDRATION  1  1/121 (0.83%)  0/59 (0.00%) 
Musculoskeletal and connective tissue disorders     
ARTHRITIS  1  1/121 (0.83%)  0/59 (0.00%) 
COSTOCHONDRITIS  1  1/121 (0.83%)  0/59 (0.00%) 
MUSCULOSKELETAL CHEST PAIN  1  1/121 (0.83%)  0/59 (0.00%) 
SYSTEMIC LUPUS ERYTHEMATOSUS  1  3/121 (2.48%)  1/59 (1.69%) 
Nervous system disorders     
HEADACHE  1  0/121 (0.00%)  1/59 (1.69%) 
POLYNEUROPATHY  1  1/121 (0.83%)  0/59 (0.00%) 
ACUTE POLYNEUROPATHY  1  1/121 (0.83%)  0/59 (0.00%) 
Psychiatric disorders     
DEPRESSION  1  1/121 (0.83%)  0/59 (0.00%) 
PSYCHOTIC DISORDER  1  1/121 (0.83%)  1/59 (1.69%) 
Renal and urinary disorders     
LUPUS NEPHRITIS  1  1/121 (0.83%)  0/59 (0.00%) 
GLOMERULONEPHRITIS  1  1/121 (0.83%)  0/59 (0.00%) 
MESANGIOPROLIFERATIVE GLOMERULONEPHRITIS  1  1/121 (0.83%)  0/59 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ALVEOLITIS  1  1/121 (0.83%)  0/59 (0.00%) 
PLEURAL EFFUSION  1  1/121 (0.83%)  0/59 (0.00%) 
Skin and subcutaneous tissue disorders     
ANGIOEDEMA  1  0/121 (0.00%)  1/59 (1.69%) 
Vascular disorders     
LUPUS VASCULITIS  1  0/121 (0.00%)  1/59 (1.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   90/121 (74.38%)   41/59 (69.49%) 
Cardiac disorders     
PALPITATIONS  1  2/121 (1.65%)  4/59 (6.78%) 
Gastrointestinal disorders     
NAUSEA  1  12/121 (9.92%)  4/59 (6.78%) 
DIARRHOEA  1  14/121 (11.57%)  4/59 (6.78%) 
CONSTIPATION  1  2/121 (1.65%)  3/59 (5.08%) 
ABDOMINAL PAIN  1  11/121 (9.09%)  0/59 (0.00%) 
ABDOMINAL PAIN UPPER  1  7/121 (5.79%)  5/59 (8.47%) 
General disorders     
CHEST PAIN  1  7/121 (5.79%)  4/59 (6.78%) 
Infections and infestations     
INFLUENZA  1  7/121 (5.79%)  3/59 (5.08%) 
SINUSITIS  1  8/121 (6.61%)  4/59 (6.78%) 
BRONCHITIS  1  7/121 (5.79%)  4/59 (6.78%) 
PHARYNGITIS  1  3/121 (2.48%)  4/59 (6.78%) 
GASTROENTERITIS  1  7/121 (5.79%)  2/59 (3.39%) 
NASOPHARYNGITIS  1  3/121 (2.48%)  7/59 (11.86%) 
URINARY TRACT INFECTION  1  13/121 (10.74%)  5/59 (8.47%) 
UPPER RESPIRATORY TRACT INFECTION  1  25/121 (20.66%)  9/59 (15.25%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  15/121 (12.40%)  5/59 (8.47%) 
ARTHRALGIA  1  11/121 (9.09%)  4/59 (6.78%) 
MUSCLE SPASMS  1  1/121 (0.83%)  4/59 (6.78%) 
Nervous system disorders     
HEADACHE  1  25/121 (20.66%)  10/59 (16.95%) 
DIZZINESS  1  6/121 (4.96%)  5/59 (8.47%) 
Psychiatric disorders     
INSOMNIA  1  10/121 (8.26%)  5/59 (8.47%) 
DEPRESSION  1  7/121 (5.79%)  3/59 (5.08%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  10/121 (8.26%)  5/59 (8.47%) 
NASAL CONGESTION  1  3/121 (2.48%)  3/59 (5.08%) 
PHARYNGOLARYNGEAL PAIN  1  12/121 (9.92%)  2/59 (3.39%) 
Skin and subcutaneous tissue disorders     
ACNE  1  7/121 (5.79%)  0/59 (0.00%) 
RASH  1  4/121 (3.31%)  3/59 (5.08%) 
PRURITUS  1  4/121 (3.31%)  3/59 (5.08%) 
Vascular disorders     
HYPERTENSION  1  4/121 (3.31%)  3/59 (5.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00119678     History of Changes
Other Study ID Numbers: IM101-042
First Submitted: June 30, 2005
First Posted: July 14, 2005
Results First Submitted: January 10, 2011
Results First Posted: May 9, 2011
Last Update Posted: September 22, 2014