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Trial record 14 of 146 for:    lupus AND Lupus Nephritis

Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis (ACCESS)

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ClinicalTrials.gov Identifier: NCT00774852
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : October 9, 2014
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Lupus Nephritis
Lupus Erythematosus, Systemic
Interventions Drug: abatacept
Drug: cyclophosphamide
Drug: azathioprine
Drug: prednisone
Drug: abatacept placebo
Drug: azathioprine placebo
Enrollment 137

Recruitment Details Participants ages 16 and older with systemic lupus erythematosus (SLE) who met entry criteria were enrolled into the study between November 2008 and June 2012.
Pre-assignment Details  
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment. Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Period Title: Overall Study
Started 69 68
Completed 24 27
Not Completed 45 41
Reason Not Completed
Adverse Event             9             6
Death             2             1
Lack of Efficacy             3             7
Lost to Follow-up             9             5
Physician Decision             2             6
Pregnancy             1             2
Withdrawal by Subject             2             2
Non-responder             15             11
Subject non-compliance             0             1
Protocol Violation             1             0
Subject received prohibited medication             1             0
Arm/Group Title Abatacept Placebo Total
Hide Arm/Group Description Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment. Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment. Total of all reporting groups
Overall Number of Baseline Participants 66 68 134
Hide Baseline Analysis Population Description
Intent-to-treat sample
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
<=18 years
1
   1.5%
0
   0.0%
1
   0.7%
Between 18 and 65 years
65
  98.5%
67
  98.5%
132
  98.5%
>=65 years
0
   0.0%
1
   1.5%
1
   0.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 68 participants 134 participants
32.0  (10.1) 32.7  (12.0) 32.4  (11.1)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
<18 Years 1 0 1
18-20 Years 7 5 12
21-24 Years 10 15 25
>24 Years 48 48 96
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
Female
58
  87.9%
64
  94.1%
122
  91.0%
Male
8
  12.1%
4
   5.9%
12
   9.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
United States 58 59 117
Mexico 8 9 17
Duration of Lupus Nephritis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
<1 Year 47 48 95
>=1 Year 19 20 39
[1]
Measure Description: Years since lupus nephritis was diagnosed by a physician. This information was obtained by medical history during the Baseline Visit.
Serum Creatinine   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 66 participants 68 participants 134 participants
1.3  (0.7) 1.2  (0.6) 1.2  (0.7)
[1]
Measure Description: The highest serum creatinine reading from either screening or baseline visit was used for this measure. According to Harrison's Principles of Internal Medicine, normal results are 0.6 to 1.2 mg/dL for men and 0.5 to 0.9 mg/dL for women. This test measures kidney function. Abnormal kidney function results in increased levels of serum creatinine.
eGFR   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73m^2
Number Analyzed 66 participants 68 participants 134 participants
64.6  (36.2) 58.4  (27.8) 61.4  (32.2)
[1]
Measure Description: Estimated glomerular filtration rate (eGFR) is a calculation based on serum creatinine result, age, sex and race. GFR is a marker of kidney function. Normal GFR is approximately 100mL/min/1.73m^2. Lower GFRs reflect poorer kidney function.
Urine Protein (24 hour collection)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/day
Number Analyzed 66 participants 68 participants 134 participants
3814.8  (3063.6) 4509.4  (3987.7) 4167.3  (3566.4)
[1]
Measure Description: Several measures of kidney (renal) function were obtained from a 24 hour urine collection: urine protein (mg/day), -creatinine (mg/day), -protein: -creatinine ratio (mg:mg). Urine protein normal values: less than 80 mg/day. Greater levels of urine protein may indicate kidney disease.
Urine Creatinine (24 hour collection)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/day
Number Analyzed 66 participants 68 participants 134 participants
1081.5  (532.4) 1132.8  (409.3) 1107.6  (472.8)
[1]
Measure Description: Several measures of kidney (renal) function were obtained from a 24 hour urine collection: urine protein (mg/day), -creatinine (mg/day), -protein: -creatinine ratio (mg:mg). Urine creatinine normal range: 500 to 2000 mg/day. An abnormal result may indicate poorer kidney function.
Urine Protein-to-Creatinine Ratio (24 hour collection)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg:mg
Number Analyzed 66 participants 68 participants 134 participants
3.6  (2.6) 4.1  (3.4) 3.9  (3.0)
[1]
Measure Description: Several measures of kidney (renal) function were obtained from a 24 hour urine collection: urine protein (mg/day), -creatinine (mg/day), -protein: -creatinine ratio (mg:mg). Urine protein-to-creatinine ratio is an indicator of proteinuria. A ratio greater than 0.2 mg:mg is considered an indicator of poor kidney function.
Urine Protein-to-Creatinine Ratio   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
> 3 mg:mg 27 31 58
<= 3 mg:mg 39 37 76
[1]
Measure Description: Urine protein: creatinine ratio is a comparison of protein to creatinine in urine which is an indicator of proteinuria. A ratio greater than 0.2 mg:mg is considered an indicator of poor kidney function. Participants are stratified as either 1.) greater than or 2.) <=3 mg:mg.
Average Daily Prednisone Dose   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/day
Number Analyzed 66 participants 68 participants 134 participants
47.0  (18.5) 39.0  (20.3) 42.8  (19.8)
[1]
Measure Description: Average daily prednisone dose taken by participants during 14 days prior to initiation of study drug.
Anti-dsDNA   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
Negative 14 15 29
Equivocal (“borderline”) 2 2 4
Positive 49 50 99
[1]
Measure Description: Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. A positive test for autoantibodies to double-stranded DNA is based on the normal range from the local laboratory. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Not all subjects had available data.
Serum Complement Test C3   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 66 participants 68 participants 134 participants
64.2  (25.5) 70.4  (30.4) 67.3  (28.1)
[1]
Measure Description: Serum complement tests (complement C3, -C4 and -CD50) measure a group of proteins in the blood. Low blood levels of complement are common in people who have active lupus. Harrison’s Principles of Internal Medicine normal values: C3 83 – 177 mg/dL.
Serum Complement Test C4   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 66 participants 68 participants 134 participants
13.0  (8.9) 13.4  (6.8) 13.2  (7.9)
[1]
Measure Description: Serum complement tests (complement C3, -C4 and -CD50) measure a group of proteins in the blood. Low blood levels of complement are common in people who have active lupus. Harrison's Principles of Internal Medicine normal values: C4 = 16 - 47 mg/dL.
Serum Complement Test CH50   [1] 
Mean (Standard Deviation)
Unit of measure:  units/mL
Number Analyzed 66 participants 68 participants 134 participants
47.0  (41.3) 61.3  (52.2) 54.3  (47.5)
[1]
Measure Description: Serum complement tests (complement C3, -C4 and -CD50) measure a group of proteins in the blood. Low blood levels of complement are common in people who have active lupus. Harrison's Principles of Internal Medicine normal values: CD50 (a measure of total complement activity) 41 - 90 hemolytic units/mL.
Participants with Hypocomplementemia   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 66 participants 68 participants 134 participants
C3 hypocomplementemia 47 44 91
C4 hypocomplementemia 39 37 76
CH50 hypocomplementemia 29 23 52
[1]
Measure Description: Participants were categorized as having hypocomplementemia if their serum complement test results (C3, C4 and/or CH50) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus.Not all subjects had available data.
1.Primary Outcome
Title Number of Participants With Complete Response
Hide Description Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as CR failures for all subsequent visits. CRs are those who successfully responded to treatment and have minimal activity of their lupus nephritis.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 66 68
Measure Type: Number
Unit of Measure: participants
22 21
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]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Chi-squared
Comments Two-sided Pearson's chi-square test
2.Secondary Outcome
Title Number of Participants With Partial Response
Hide Description Outcome measure description: Partial response definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol. Participants who discontinued treatment and/or terminated from the study in the first 24 weeks were defined as complete response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 66 68
Measure Type: Number
Unit of Measure: participants
39 40
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]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Chi-squared
Comments Two-sided Pearson's chi-square test
3.Secondary Outcome
Title Number of Participants With a Complete or Partial Response
Hide Description

Complete response: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder.

Partial response: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline visit, and improvement >= to 50% in the urine protein to creatinine ratio at either screening or baseline visit, and prednisone dose has been tapered to 10 mg/day or according to protocol dosing allowances in protocol.

Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs successfully responded to treatment and have minimal activity of their lupus nephritis. Partial responders showed some response to treatment and low activity of their lupus nephritis.

Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Week 24 Complete Response: Abatacept Week 24 Complete Response: Placebo Week 24 Partial Response: Abatacept Week 24 Partial Response: Placebo
Hide Arm/Group Description:
At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
Overall Number of Participants Analyzed 22 21 17 19
Measure Type: Number
Unit of Measure: participants
12 14 13 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Week 24 Complete Response: Abatacept, Week 24 Complete Response: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Chi-squared
Comments Two-sided Pearson’s chi-square test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Week 24 Partial Response: Abatacept, Week 24 Partial Response: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Chi-squared
Comments Two-sided Pearson’s chi-square test
4.Secondary Outcome
Title Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52
Hide Description Complete response definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a complete responder (CR). Participants who discontinued treatment and/or terminated from the study were defined as response failures for all subsequent visits. CRs are those who successfully responded to treatment and had minimal activity of their lupus nephritis.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Week 24 Complete Response: Abatacept Week 24 Complete Response: Placebo
Hide Arm/Group Description:
At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: participants
11 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Week 24 Complete Response: Abatacept, Week 24 Complete Response: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Chi-squared
Comments Two-sided Pearson’s chi-square test
5.Secondary Outcome
Title Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response
Hide Description A complete proteinuria and prednisone response is defined as urine protein-to-creatinine ratio <0.5 and prednisone dose tapered to <= 10mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Complete responders are those who successfully responded to treatment and have minimal activity of their lupus nephritis.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 66 68
Measure Type: Number
Unit of Measure: participants
22 21
6.Secondary Outcome
Title Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response
Hide Description A partial proteinuria and prednisone response is defined as an improvement (reduction) of >=50% in the urine protein-to-creatinine ratio at either visit -1 or 0, and prednisone dose has been tapered to 10 mg/day. Subjects who discontinued treatment or terminated from the study in the first 24 weeks are defined as response failures for all subsequent visits. Partial responders are those who showed some response to treatment and low activity of their lupus nephritis.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 66 68
Measure Type: Number
Unit of Measure: participants
39 42
7.Secondary Outcome
Title Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study
Hide Description A participant who did not meet the criteria for either a complete response or a partial response at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the site investigator judged that the participant could benefit from continued participation. Non responders did not respond to treatment and lupus activity is moderate to severe.
Time Frame Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Week 24 Non-Responder: Abatacept Week 24 Non-Responder: Placebo
Hide Arm/Group Description:
Participants who were in the abatacept arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
Participants who were in the placebo arm and non-responders at Week 24 either terminated or continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
Overall Number of Participants Analyzed 15 11
Measure Type: Number
Unit of Measure: participants
0 0
8.Secondary Outcome
Title Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response
Hide Description A participant who did not meet the criteria for either a complete response (CR) or a partial response (PR) at Week 24 was considered a non-responder. After Week 24, non-responders were terminated from the study and treated according to best clinical judgment unless the investigator judged that the participant may benefit from continued participation. CR definition: a serum creatinine <= 1.2 mg/dL or <=125% of the higher value at either screening or baseline visit, protein-to-creatinine ratio <0.5, and prednisone dose tapered to <=10 mg/day or prednisone dosing allowances in protocol. Participants had to meet all of the referenced criteria to be considered a CR. PR definition: a serum creatinine <= 1.2 mg/dL or <= to 125% of the higher value at either screening or baseline, and improvement (reduction) >= to 50% in the urine protein to creatinine ratio at either screening or baseline, and prednisone dose has been tapered to 10 mg/day.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Week 24 Non-Responder Who Continued Treatment: Abatacept Week 24 Non-Responder Who Continued Treatment: Placebo
Hide Arm/Group Description:
Participants who were in the abatacept arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept up to Week 48 and azathioprine up to Week 52
Participants who were in the placebo arm and non-responders at Week 24 who continued participation. If participation continued, participants continued abatacept placebo up to Week 48 and azathioprine up to Week 52
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Lupus Disease Activity – Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104
Hide Description

Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.

Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. One measure used to assess disease activity is the number of participants who were anti-dsDNA positive at baseline but negative at Week 104. Going from positive to negative is indicative of lowered lupus activity.

Time Frame Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants from Intent-to-treat population who had positive anti-dsDNA at baseline and completed Week 104.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: participants
3 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Chi-squared
Comments Two-sided Pearson’s chi-squared test
10.Secondary Outcome
Title Lupus Disease Activity – Negative Anti-dsDNA
Hide Description

Lupus disease activity was assessed by 7 different measures: reduction in anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.

Participants with systemic lupus erythematosus (SLE) may have autoantibodies (e.g., self against self) to double-stranded DNA. Double-stranded DNA is one of multiple diagnostic tests for SLE and levels may be associated with disease activity. This measure was the number of participants who had negative anti-dsDNA at Week 104. Having a negative score is indicative of low lupus disease activity.

Time Frame Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat participants who completed Week 104.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 24 27
Measure Type: Number
Unit of Measure: participants
7 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Chi-squared
Comments Two-sided Pearson’s chi-squared test
11.Secondary Outcome
Title Lupus Disease Activity – Presence of Hypocomplementemia
Hide Description

Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.

Participants were categorized as having hypocomplementemia if their serum complement test results (C3, and C4) were below the normal range at the site. Below normal complement test results are indicative of active lupus erythematosus.

Time Frame Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat participants who completed Week 104 and had hypocomplementemia data available
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 23 27
Measure Type: Number
Unit of Measure: participants
C3 Hypocomplementemia 12 11
C4 Hypocomplementemia 11 8
12.Secondary Outcome
Title Lupus Disease Activity – Frequency of Flares
Hide Description

Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.

Flares can be renal or non-renal. A renal flare is defined as two successive evaluations at least 1 week apart as proteinuria >1 gm/24h for participants who attain a complete response at Week 12 and for all other participants either 1) Increasing serum creatinine and persistent proteinuria, or 2) Worsening proteinuria. A non-renal flare is defined as any new post-baseline BILAG A in a non-renal organ system using BILAG-2004. This outcome measures the number of participants with the presence of renal and non-renal flares from Week 24 through Week 52 by response status. Having flares is indicative of more lupus disease activity.

Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data between weeks 24 and 52.
Arm/Group Title Week 24 Complete Response: Abatacept Week 24 Complete Response: Placebo Week 24 Partial Response: Abatacept Week 24 Partial Response: Placebo Week 24 No Response: Abatacept Week 24 No Response: Placebo
Hide Arm/Group Description:
At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
At Week 28 participants assigned to Abatacept group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
At Week 28 participants assigned to Placebo group who were classified as a non-responder at their Week 24 visit either terminated from the study at Wk 28 or continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52, at the discretion of the investigators
Overall Number of Participants Analyzed 22 21 17 19 14 11
Measure Type: Number
Unit of Measure: participants
Participants with a Renal Flare 0 2 1 3 1 0
Participants with at least 1 Non-renal Flare 1 1 0 1 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Week 24 Complete Response: Abatacept, Week 24 Complete Response: Placebo
Comments Comparison of groups with renal flare
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Chi-squared
Comments Pearson’s
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Week 24 Partial Response: Abatacept, Week 24 Partial Response: Placebo
Comments Comparison of groups with renal flare
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Chi-squared
Comments Pearson’s
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Week 24 Complete Response: Abatacept, Week 24 Complete Response: Placebo
Comments Comparison of groups with at least one non-renal flare
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Chi-squared
Comments Pearson’s
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Week 24 Partial Response: Abatacept, Week 24 Partial Response: Placebo
Comments Comparison of groups with at least one non-renal flare
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Chi-squared
Comments Pearson’s
13.Secondary Outcome
Title Lupus Disease Activity – Patient Global Assessment
Hide Description

Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.

PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease.

Time Frame Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat who completed Week 104 and had patient global assessment data available.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 24 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.2  (19.5) 18.7  (26.7)
14.Secondary Outcome
Title Lupus Disease Activity – Patient Global Assessment Percent Change From Baseline
Hide Description

Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment (PGA), SF36 total scores, and BILAG-2004 scores.

PGA is measured on a 100mm scale and assessed at Weeks 0, 12, 24, 52, and 104. Higher values indicate greater burden of disease.

Time Frame Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat who completed Week 104 and had patient global assessment data available.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 24 26
Mean (Standard Deviation)
Unit of Measure: percent change
26  (343.9) -35.2  (98.0)
15.Secondary Outcome
Title Lupus Disease Activity – SF-36 Scores
Hide Description

Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.

The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life.

Time Frame Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat who completed Week 104 and had SF-36 data available.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 24 27
Mean (Standard Deviation)
Unit of Measure: Score
Week 104 Physical Component Score 49.3  (11.1) 45.3  (11.8)
Week 104 Mental Component Score 50.9  (12.7) 49.2  (12.4)
16.Secondary Outcome
Title Lupus Disease Activity – SF-36 Scores Percent Change From Baseline
Hide Description

Lupus disease activity was assessed by 7 different measures: anti-dsDNA, negative anti-dsDNA, resolution of hypocomplementemia (C3, C4), frequency of flares, patient global assessment, SF36 total scores, and BILAG-2004 scores.

The SF-36 is a quality of life assessment that was performed at Weeks 9, 24, 36, 52, and 104. Eight scale scores are derived from responses to the 36 items of the SF-36 questionnaire which were combined to produce the Physical Component Score and the Mental Component Score. The Physical Component Score is based on the Physical Functioning Scale (10 items), the Role-Physical Scale (4 items), the Bodily Pain Scale (2 items), and the General Health Scale (5 items). The Mental Component Score is based upon the Vitality Scale (4 items), the Social Functioning Scale (2 items), the Role-Emotional Scale (3 items) and the Mental Health Scale (5 items). Each component score is transformed into a 0-100 scale, with higher numbers indicating greater quality of life.

Time Frame Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat who completed Week 104 and had SF-36 data available.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:
Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment.
Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
Overall Number of Participants Analyzed 24 26
Mean (Standard Deviation)
Unit of Measure: percent change
Percent Change From Baseline on Physical Component 32.1  (49.1) 28.2  (66.4)
Percent Change from Baseline Mental Component Scor 39.6  (70.4) 37.1  (55.2)
17.Secondary Outcome
Title Lupus Disease Activity – Total BILAG-2004
Hide Description BILAG-2004 has 5 categories of scoring.Category A:defined by severe disease activity requiring any of the following treatments: 1) systemic high dose oral glucocorticoids, 2) IV pulse glucocorticoids, 3) systemic immunomodulators, or 4)therapeutic high dose anticoagulation in the presence of high dose steroids or immunomodulators. Category B:defined by moderate disease activity requiring any of the following treatments:1) systemic low dose oral glucocorticoids, 2) intramuscular or intra-articular or soft tissue glucocorticoids injection,3) topical glucocorticoids, 4) topical immunomodulators,5) antimalarials or thalidomide or prasterone or acitretin, or 6) symptomatic therapy.Category C:defined by mild disease.Category D is defined by inactive disease, previously affected.Category E is defined as the system never being involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.
Time Frame Week 52
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Hide Analysis Population Description
Intent-to-treat who completed Week 52 and BILAG 2004 data available.
Arm/Group Title Week 24 Complete Response: Abatacept Week 24 Complete Response: Placebo Week 24 Partial Response: Abatacept Week 24 Partial Response: Placebo
Hide Arm/Group Description:
At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
At Week 28 participants assigned to Abatacept group who were classified as a partial responder at their Week 24 visit continued to receive abatacept up to Week 48 and azathioprine up to Week 52
At Week 28 participants assigned to the Placebo group who were classified as a partial responder at their Week 24 visit continued to receive abatacept placebo up to Week 48 and azathioprine up to Week 52
Overall Number of Participants Analyzed 14 16 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (1.4) 1.9  (1.6) 3.2  (2.6) 3.5  (1.8)
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Statistical Analysis Overview Comparison Group Selection Week 24 Complete Response: Abatacept, Week 24 Complete Response: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.
Method ANCOVA
Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection Week 24 Partial Response: Abatacept, Week 24 Partial Response: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.
Method ANCOVA
Comments [Not Specified]
18.Secondary Outcome
Title Proportion of Vaccinated Participants With a Competent Immune Response
Hide Description

Among participants who are vaccinated, the number of who have a competent immune response at Week 52 as defined as having met both of the following criteria:

  1. Pneumococcal vaccination response – absolute value >= 0.35 ug/mL and, when measured 4-6 weeks after vaccination, a >=2-fold increase from baseline in serotype-specific antibody titer for at least 50% of the serotypes tested.
  2. Tetanus toxoid vaccination response – absolute value >=0.015 IU/mL and, when measured 4-6 weeks after vaccination, a 2-fold increase from baseline in antigen-specific antibody titer

Competent immune response is indicative of low disease activity.

Time Frame Week 52
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Hide Analysis Population Description
Intent-to-treat who completed Week 52 and were vaccinated.
Arm/Group Title Week 24 Complete Response: Abatacept Week 24 Complete Response: Placebo
Hide Arm/Group Description:
At Week 28 participants assigned to Abatacept group who were classified as a complete responder at their Week 24 visit discontinued abatacept and switched to overencapsulated azathioprine placebo up to Week 52
At Week 28 participants assigned to the Placebo group who were classified as a complete responder at their Week 24 visit discontinued abatacept placebo and switched to overencapsulated azathioprine up to Week 52
Overall Number of Participants Analyzed 3 4
Measure Type: Number
Unit of Measure: percentage of participants
Pneumococcal Vaccines 67 100
Tetanus Toxoid Vaccines 50 100
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Statistical Analysis Overview Comparison Group Selection Week 24 Complete Response: Abatacept, Week 24 Complete Response: Placebo
Comments Comparison of groups for Pneumococcal vaccines
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Chi-squared
Comments Pearson’s
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Week 24 Complete Response: Abatacept, Week 24 Complete Response: Placebo
Comments Comparison of groups for Tetanus Toxoid vaccines
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Chi-squared
Comments Pearson’s
Time Frame From enrollment through last follow-up visit (up to 104 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description Subjects received abatacept IV dosed according to body weight (<60 kg, 500mg; 60-100 kg, 750 mg; or >100 kg, 1 g) at the following visits: Weeks (wks) 0, 2, and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed by body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first 2 wks (subjects less than 60 kg could receive 1 mg/kg/day).* Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity requiring further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept and switched to azathioprine placebo up to Wk 52 (to assess response durability). *Based on principal investigator [PI] judgment. Subjects received abatacept placebo IV at the following visits: Weeks (wks) 0, 2 and 4, then every 4 wks until Wk 24. Subjects also received: 1) cyclophosphamide 500 mg IV every 2 wks for 6 doses followed by azathioprine 2 mg/kg/day by mouth dosed according to body weight at Visit 6 (rounded to the nearest 25 mg and to a maximum dose of 200 mg) for 16 wks; 2) prednisone 60 mg/day for the first two wks (subjects less than 60 kg could receive 1 mg/kg/day.*Prednisone was tapered until Wk 12 to a dose of 10 mg/day. This dose was continued until Wk 24 unless the subject had a prednisone-related toxicity that required further reduction.* After Wk 24, prednisone was permitted to be tapered further to 5mg/day.* Subjects who achieved a complete response discontinued abatacept placebo and continued azathioprine up to Wk 52. *Based on principal investigator [PI] judgment.
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 (%) # Events Affected / at Risk (%) # Events
Total   28/69 (40.58%)      26/68 (38.24%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Leukopenia  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Lymphopenia  1  1/69 (1.45%)  2 3/68 (4.41%)  3
Pancytopenia  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Cardiac disorders     
Acute myocardial infarction  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Atrial thrombosis  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Cardiac failure congestive  1  1/69 (1.45%)  1 1/68 (1.47%)  1
Lupus myocarditis  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Myocardial infarction  1  0/69 (0.00%)  0 2/68 (2.94%)  2
Pericardial effusion  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Pericarditis  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Pleuropericarditis  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Ventricular fibrillation  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Congenital, familial and genetic disorders     
Pulmonary malformation  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Gastrointestinal disorders     
Nausea  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Vomiting  1  1/69 (1.45%)  1 0/68 (0.00%)  0
General disorders     
Adverse drug reaction  1  1/69 (1.45%)  1 1/68 (1.47%)  1
Pyrexia  1  2/69 (2.90%)  2 0/68 (0.00%)  0
Infections and infestations     
Bacteraemia  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Bronchitis  1  2/69 (2.90%)  2 1/68 (1.47%)  1
Cellulitis  1  1/69 (1.45%)  1 1/68 (1.47%)  1
Clostridium difficile colitis  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Gastroenteritis  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Gastroenteritis viral  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Infection  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Pneumonia  1  3/69 (4.35%)  3 3/68 (4.41%)  3
Pyelonephritis  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Sepsis  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Septic shock  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Tubo-ovarian abscess  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Urinary tract infection  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Viral infection  1  1/69 (1.45%)  1 1/68 (1.47%)  1
Viral myocarditis  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Injury, poisoning and procedural complications     
Drug toxicity  1  0/69 (0.00%)  0 2/68 (2.94%)  2
Radius fracture  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Rib fracture  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Thermal burn  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Investigations     
Blood immunoglobulin G decreased  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteonecrosis  1  1/69 (1.45%)  1 1/68 (1.47%)  1
Systemic lupus erythematosus  1  5/69 (7.25%)  7 4/68 (5.88%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Nervous system disorders     
Haemorrhage intracranial  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Hemisensory neglect  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Psychiatric disorders     
Depression  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Mental status changes  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Renal and urinary disorders     
Acute prerenal failure  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Nephritis  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Nephrotic syndrome  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Renal failure  1  3/69 (4.35%)  3 1/68 (1.47%)  1
Renal failure acute  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Renal impairment  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Reproductive system and breast disorders     
Oedema genital  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Interstitial lung disease  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Pleural effusion  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Pulmonary embolism  1  2/69 (2.90%)  2 1/68 (1.47%)  1
Vascular disorders     
Deep vein thrombosis  1  1/69 (1.45%)  1 1/68 (1.47%)  1
Hypertension  1  1/69 (1.45%)  1 0/68 (0.00%)  0
Peripheral ischaemia  1  0/69 (0.00%)  0 1/68 (1.47%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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 (%) # Events Affected / at Risk (%) # Events
Total   39/69 (56.52%)      42/68 (61.76%)    
Blood and lymphatic system disorders     
Leukopenia  1  10/69 (14.49%)  13 8/68 (11.76%)  9
Gastrointestinal disorders     
Nausea  1  7/69 (10.14%)  8 6/68 (8.82%)  13
Vomiting  1  6/69 (8.70%)  6 3/68 (4.41%)  3
General disorders     
Adverse drug reaction  1  3/69 (4.35%)  3 5/68 (7.35%)  6
Oedema peripheral  1  6/69 (8.70%)  6 3/68 (4.41%)  3
Chest pain  1  0/69 (0.00%)  0 4/68 (5.88%)  4
Infections and infestations     
Bronchitis  1  5/69 (7.25%)  5 3/68 (4.41%)  4
Herpes zoster  1  4/69 (5.80%)  4 2/68 (2.94%)  2
Sinusitis  1  2/69 (2.90%)  2 6/68 (8.82%)  7
Upper respiratory tract infection  1  9/69 (13.04%)  12 12/68 (17.65%)  17
Urinary tract infection  1  4/69 (5.80%)  7 9/68 (13.24%)  11
Metabolism and nutrition disorders     
Dehydration  1  4/69 (5.80%)  4 2/68 (2.94%)  2
Musculoskeletal and connective tissue disorders     
Systemic lupus erythematosus  1  1/69 (1.45%)  1 6/68 (8.82%)  6
Nervous system disorders     
Headache  1  2/69 (2.90%)  2 4/68 (5.88%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00774852     History of Changes
Other Study ID Numbers: DAIT ITN034AI
First Submitted: October 16, 2008
First Posted: October 17, 2008
Results First Submitted: August 18, 2014
Results First Posted: October 9, 2014
Last Update Posted: February 8, 2016