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| Name | Class |
|---|---|
| Immune Tolerance Network (ITN) | NETWORK |
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This study is for individuals with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.
Lupus nephritis is an inflammation of the kidney that occurs in patients with systemic lupus erythematosus (SLE). It is caused by the immune system attacking the kidney and is among the most serious complications of SLE: left untreated it can cause long term damage to the kidneys or, in some cases, result in kidney failure.
One of the more common treatments for lupus nephritis is the "Euro-lupus" therapy. In this therapy, patients receive three different drugs - cyclophosphamide, azathioprine and prednisone - over the course of several months. However, some patients do not respond to this therapy and many only show some improvement.
In this ACCESS trial for lupus nephritis, an experimental medication known as abatacept will be added to the Euro-lupus therapy to assess if it works better than Euro-lupus therapy alone. Abatacept is a man-made protein that suppresses parts of the immune system that can cause autoimmune disease. While abatacept is experimental for lupus, it has been approved by the FDA to treat rheumatoid arthritis. Abatacept is also being studied for use in other autoimmune diseases, like multiple sclerosis and type 1 diabetes.
Participants in the ACCESS trial for lupus nephritis will receive bi-weekly intravenous infusions of cyclophosphamide for 3 months, then will take azathioprine tablets daily for at least 3 months more. Abatacept or a placebo will be administered every 2 weeks initially, then every 4 weeks for at least the first 6 months. Treatment of abatacept or placebo and azathioprine may continue for the remainder of the year. All participants will take prednisone tablets daily during the entire study.
Because the ACCESS trial is a randomized, controlled study, each participant has a 50-50 chance (like flipping a coin) of receiving abatacept. Others will receive an inactive, placebo form of the drug. Note however, that all participants will receive the Euro-lupus therapy. As a blinded (masked) study, neither participants nor study physicians will know to which group a person has been assigned.
All participants will undergo regular physical examinations, medical history and various blood and urine tests. Many of these tests will be repeated throughout the study. Participants will be asked to attend 18 study visits in the first year, and one study visit at the end of the second year.
The study will reimburse participants for certain expenses incurred as part of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Abatacept plus Euro-lupus regimen |
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| Control | Placebo Comparator | Abatacept placebo plus Euro-lupus regimen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abatacept | Drug | Intravenous infusion (500-1000 mg, dep on weight) at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response | 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Partial Response | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wofsy, MD | University of California, San Francisco | Principal Investigator |
| Betty Diamond, MD | Feinstein Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25403681 | Result | ACCESS Trial Group. Treatment of lupus nephritis with abatacept: the Abatacept and Cyclophosphamide Combination Efficacy and Safety Study. Arthritis Rheumatol. 2014 Nov;66(11):3096-104. doi: 10.1002/art.38790. | |
| 25779381 | Result | Wofsy D, Diamond B, Houssiau FA. Crossing the Atlantic: the Euro-Lupus Nephritis regimen in North America. Arthritis Rheumatol. 2015 May;67(5):1144-6. doi: 10.1002/art.39067. No abstract available. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abatacept | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| cyclophosphamide | Drug | 500 mg intravenous infusion every 2 weeks for 12 weeks |
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| azathioprine | Drug | 2 mg/kg/day orally from weeks 12-28; continue until week 52 if only partial response observed at week 24 |
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| prednisone | Drug | 60 mg/day for 2 weeks, then taper to 10 mg/day by 12 weeks, then continue on stable dose |
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| abatacept placebo | Drug | Intravenous infusion at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks |
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| azathioprine placebo | Drug | Oral capsule, daily from weeks 28 to 52, only if complete response observed at week 24 |
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| Week 24 |
| Number of Participants With a Complete or Partial Response | 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. | Week 52 |
| Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52 | 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. | Week 52 |
| Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response | 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. | Week 24 |
| Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response | 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. | Week 24 |
| Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study | 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. | Week 104 |
| Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response | 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. | Week 52 |
| Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104 | 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. | Week 104 |
| Lupus Disease Activity - Negative Anti-dsDNA | 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. | Week 104 |
| Lupus Disease Activity - Presence of Hypocomplementemia | 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. | Week 104 |
| Lupus Disease Activity - Frequency of Flares | 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. | Week 52 |
| Lupus Disease Activity - Patient Global Assessment | 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. | Week 104 |
| Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline | 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. | Week 104 |
| Lupus Disease Activity - SF-36 Scores | 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. | Week 104 |
| Lupus Disease Activity - SF-36 Scores Percent Change From Baseline | 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. | Week 104 |
| Lupus Disease Activity - Total BILAG-2004 | 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. | Week 52 |
| Proportion of Vaccinated Participants With a Competent Immune Response | 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:
Competent immune response is indicative of low disease activity. | Week 52 |
| La Jolla |
| California |
| 92037 |
| United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Feinstein Institute | Manhasset | New York | 11030 | United States |
| Seligman Center for Advanced Therapeutics (NYU) | New York | New York | 10003 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Temple University | Philadelphia | Pennsylvania | 19147 | United States |
| University of Pittsburgh Lupus Center of Excellence | Pittsburgh | Pennsylvania | 15261 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Unidad de investigación en enfermedades crónico - degenerativas SC | Guadalajara | Jalisco | 44620 | Mexico |
| El Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INNSZ) | Mexico City | Mexico |
| Immune Tolerance Network website | View source |
| Lupus Nephritis Trials Network Research | View source |
| FG001 | Placebo | 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. |
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| NOT COMPLETED |
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Intent-to-treat sample
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| ID | Title | Description |
|---|---|---|
| BG000 | Abatacept | 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. |
| BG001 | Placebo | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Duration of Lupus Nephritis | Years since lupus nephritis was diagnosed by a physician. This information was obtained by medical history during the Baseline Visit. | Number | participants |
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| Serum Creatinine | 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. | Mean | Standard Deviation | mg/dL |
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| eGFR | 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. | Mean | Standard Deviation | mL/min/1.73m^2 |
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| Urine Protein (24 hour collection) | 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. | Mean | Standard Deviation | mg/day |
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| Urine Creatinine (24 hour collection) | 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. | Mean | Standard Deviation | mg/day |
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| Urine Protein-to-Creatinine Ratio (24 hour collection) | 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. | Mean | Standard Deviation | mg:mg |
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| Urine Protein-to-Creatinine Ratio | 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. | Number | participants |
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| Average Daily Prednisone Dose | Average daily prednisone dose taken by participants during 14 days prior to initiation of study drug. | Mean | Standard Deviation | mg/day |
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| Anti-dsDNA | 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. | Number | participants |
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| Serum Complement Test C3 | 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. | Mean | Standard Deviation | mg/dL |
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| Serum Complement Test C4 | 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. | Mean | Standard Deviation | mg/dL |
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| Serum Complement Test CH50 | 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. | Mean | Standard Deviation | units/mL |
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| Participants with Hypocomplementemia | 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. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Complete Response | 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. | Intent-to-treat | Posted | Number | participants | Week 24 |
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| Secondary | Number of Participants With Partial Response | 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. | Intent-to-treat | Posted | Number | participants | Week 24 |
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| Secondary | Number of Participants With a Complete or Partial Response | 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. | Intent-to-treat | Posted | Number | participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved a Complete Response by Week 24 and Maintained the Complete Response Through Week 52 | 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. | Intent-to-treat | Posted | Number | participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Complete Response | 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. | Intent-to-treat | Posted | Number | participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Fulfilling the Proteinuria and Prednisone Criteria of a Partial Response | 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. | Intent-to-treat | Posted | Number | participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study | 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. | Intent-to-treat | Posted | Number | participants | Week 104 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieved No Response at 24 Weeks and Continued in the Study , Achieving a Complete or Partial Response | 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. | Intent-to-treat | Posted | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - Participants Who Were Anti-dsDNA Positive at Baseline and Negative at Week 104 | 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. | Participants from Intent-to-treat population who had positive anti-dsDNA at baseline and completed Week 104. | Posted | Number | participants | Week 104 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - Negative Anti-dsDNA | 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. | Intent-to-treat participants who completed Week 104. | Posted | Number | participants | Week 104 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - Presence of Hypocomplementemia | 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. | Intent-to-treat participants who completed Week 104 and had hypocomplementemia data available | Posted | Number | participants | Week 104 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - Frequency of Flares | 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. | Intent-to-treat with available data between weeks 24 and 52. | Posted | Number | participants | Week 52 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - Patient Global Assessment | 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. | Intent-to-treat who completed Week 104 and had patient global assessment data available. | Posted | Mean | Standard Deviation | units on a scale | Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - Patient Global Assessment Percent Change From Baseline | 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. | Intent-to-treat who completed Week 104 and had patient global assessment data available. | Posted | Mean | Standard Deviation | percent change | Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - SF-36 Scores | 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. | Intent-to-treat who completed Week 104 and had SF-36 data available. | Posted | Mean | Standard Deviation | Score | Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - SF-36 Scores Percent Change From Baseline | 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. | Intent-to-treat who completed Week 104 and had SF-36 data available. | Posted | Mean | Standard Deviation | percent change | Week 104 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Lupus Disease Activity - Total BILAG-2004 | 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. | Intent-to-treat who completed Week 52 and BILAG 2004 data available. | Posted | Mean | Standard Deviation | units on a scale | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Vaccinated Participants With a Competent Immune Response | 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:
Competent immune response is indicative of low disease activity. | Intent-to-treat who completed Week 52 and were vaccinated. | Posted | Number | percentage of participants | Week 52 |
|
From enrollment through last follow-up visit (up to 104 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abatacept | 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. | 28 | 69 | 39 | 69 | ||
| EG001 | Placebo | 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. | 26 | 68 | 42 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Lupus myocarditis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary malformation | Congenital, familial and genetic disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Viral myocarditis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hemisensory neglect | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Operations Program | DAIT/NIAID | 301-594-7669 | DAITClinicalTrialsGov@niaid.nih.gov |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| D003520 | Cyclophosphamide |
| D001379 | Azathioprine |
| D000255 | Adenosine Triphosphate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| 18-20 Years |
|
| 21-24 Years |
|
| >24 Years |
|
| Male |
|
| Mexico |
|
| >=1 Year |
|
| <= 3 mg:mg |
|
| Equivocal ("borderline") |
|
| Positive |
|
| C4 hypocomplementemia |
|
| CH50 hypocomplementemia |
|
| OG001 | Placebo | 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. |
|
|
|
| OG002 | Week 24 Partial Response: Abatacept | 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 |
| OG003 | Week 24 Partial Response: Placebo | 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 |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Placebo |
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. |
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| OG001 |
| Placebo |
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. |
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| Participants |
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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
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| OG001 | Placebo | 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. |
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| OG001 | Placebo | 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. |
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| OG001 | Placebo | 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. |
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| OG002 | Week 24 Partial Response: Abatacept | 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 |
| OG003 | Week 24 Partial Response: Placebo | 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 |
| OG004 | Week 24 No Response: Abatacept | 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 |
| OG005 | Week 24 No Response: Placebo | 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 |
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| Placebo |
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. |
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| Placebo |
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. |
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| OG001 | Placebo | 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. |
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| OG001 | Placebo | 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. |
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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
| OG002 | Week 24 Partial Response: Abatacept | 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 |
| OG003 | Week 24 Partial Response: Placebo | 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 |
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| Participants |
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