Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00430677
Other study ID # IM101-075
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received February 1, 2007
Last updated March 3, 2015
Start date June 2007
Est. completion date August 2011

Study information

Verified date March 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.


Description:

Double Blind Period: Treatment, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, Active Control, Safety/Efficacy Study

Open Label Period: Prevention, Single Group Assignment, Open Label, Uncontrolled, Safety/Efficacy Study


Recruitment information / eligibility

Status Terminated
Enrollment 423
Est. completion date August 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry

- Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria [2003], excluding Class III [C], IV-S [C] and IV-G [C], or the World Health Organization Class III or IV classification criteria [1982], excluding Class IIIc, IVd). If the renal biopsy was performed >3 months but =12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA >upper limit of normal range.

- A stable serum creatinine =3 mg/dL

Exclusion Criteria:

- Subjects with a rise in serum creatinine of =1 mg/dL within 1 month prior to the screening visit

- Subjects with drug-induced SLE, as opposed to idiopathic SLE

- Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus

- Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis [MS])

- Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).

- Subjects who have received treatment with rituximab < 6 months prior to the screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily
Abatacept
intravenous solution, injectable, 30 mg/kg, every 28 days
Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days
Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily
Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days

Locations

Country Name City State
Argentina Local Institution Capital Federal Buenos Aires
Argentina Local Institution Ciudad Autonoma De Buenos Aire Buenos Aires
Argentina Local Institution Cordoba
Argentina Local Institution Tucuman
Australia Local Institution Clayton Victoria
Australia Local Institution Heidelberg Victoria
Australia Local Institution Liverpool New South Wales
Australia Local Institution Parkville Victoria
Belgium Local Institution Bruxelles
Belgium Local Institution Leuven
Brazil Local Institution Curitiba Parana
Brazil Local Institution Goiania Goias
Brazil Local Institution Porto Alegre Rio Grande Do Sul
Brazil Local Institution Rio De Janeiro
Brazil Local Institution Sao Paulo
Canada Local Institution Edmonton Alberta
Canada Local Institution Quebec
Canada Local Institution Toronto Ontario
Canada Local Institution Winnipeg Manitoba
China Local Institution Beijing Beijing
China Local Institution Beijing Beijing
China Local Institution Beijing Beijing
China Local Institution Beijing Beijing
China Local Institution Guangzhou Guangdong
China Local Institution Shanghai Shanghai
China Local Institution Shanghai Shanghai
China Local Institution Xi'an Shanxi
France Local Institution Creteil Cedex
France Local Institution Paris Cedex 13
France Local Institution Strasbourg Cedex
France Local Institution Toulouse Cedex 4
Hong Kong Local Institution Hong Kong
India Local Institution Ahmedabad Gujarat
India Local Institution Bangalore Karnataka
India Local Institution Bangalore Karnataka
India Local Institution Gujarat Ahmedabad
India Local Institution Hyderabad
India Local Institution Kochi Kerala
India Local Institution Mumbai Maharajhsra
India Local Institution Nadiad Gujarat
India Local Institution Secunderabad Andhra Pradesh
India Local Institution Visakhapatnam
Korea, Republic of Local Institution Seoul Sungdong-Gu
Korea, Republic of Local Institution Seoul
Korea, Republic of Local Institution Seoul
Mexico Local Institution Aguascalientes
Mexico Local Institution Guadalajara Jalisco
Mexico Local Institution Guadalajara Jalisco
Mexico Local Institution Merida Yucatan
Mexico Local Institution Metepec Estado De Mexico
Mexico Local Institution Mexico City Distrito Federal
Mexico Local Institution Monterrey Nuevo Leon
Mexico Local Institution San Luis Potosi
Poland Local Institution Bydgoszcz
Poland Local Institution Gdansk
Poland Local Institution Wroclaw
Russian Federation Local Institution Ekaterinburg
Russian Federation Local Institution Moscow
Russian Federation Local Institution Yaroslaval
South Africa Local Institution Johannesburg Gauteng
South Africa Local Institution Observatory Western Cape
South Africa Local Institution Panorama Western Cape
Taiwan Local Institution Kaohsiung
Taiwan Local Institution Taichung
Taiwan Local Institution Taichung
Taiwan Local Institution Taipei
Taiwan Local Institution Taoyuan
Turkey Local Institution Gaziantep
United Kingdom Local Institution Cambridge Cambridgeshire
United Kingdom Local Institution London Greater London
United States University Of Alabama At Birmingham Birmingham Alabama
United States Boston University School Of Medicine Boston Massachusetts
United States Suny Downstate Medical Center Brooklyn New York
United States University Of North Carolina At Chapel Hill Chapel Hill North Carolina
United States University Of Kansas Medical Center Kansas City Kansas
United States Rheumatology Consultants Pllc Knoxville Tennessee
United States Northshore Lij Health System Lake Success New York
United States Wallace Rheumatic Study Center Los Angeles California
United States The Feinstein Institute For Medical Research Manhasset New York
United States Hennepin County Medical Center Minneapolis Minnesota
United States Ok Medical Research Foundation Oklahoma City Oklahoma
United States Virginia Mason Medical Center Seattle Washington
United States Suny Upstate Medical University Syracuse New York
United States Arizona Arthritis Center Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  China,  France,  Hong Kong,  India,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  South Africa,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period PR is either CRR, Partial Renal Response(PRR),or no Response(NR).
CRR= Serum creatinine(SC)is normal, Inactive urinary sediment, No cellular casts, Urinary protein/creatinine (UPCR) ratio <56.5 mg/mmoL; PRR= SC is normal OR SC not >25% above BL, RBCs at reference range, UPCR <56.5 mg/mmoL OR =50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the BL ratio; NR= Not achieving either a CRR or a PRR. Participants achieved response if criteria at both months 11 and 12 (Days 337 and 365) were met. Participants who Early discontinuations were categorized as NR.
Month 12 No
Primary Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. Day 1 (randomization) to 12 months. No
Secondary Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. Day 1 to 12 months No
Secondary Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period Confirmed at 2 consecutive visits. CRR defined as meeting all of 5 criteria. Renal function (RF): (Glomerular filtration rate [GFR] calculated using Modification of Diet in Renal Diseases equation equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. At Month 12 from Day 1 No
Secondary Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology) RI is defined as meeting all of the following criteria. Renal function: If MDRD is abnormal at screening, within 10% of the MDRD at screening; if MDRD is 60-89 at screening, greater than or equal to 50% improvement based on the screening value or 90% or greater of MDRD at screening; if MDRD is 15-59 at screening, if MDRD is normal at screening-within 10% of the MDRD at screening. Proteinuria: improvement greater than or equal to 50% from screening. Hematuria: red blood cell (RBC)count within normal limit of central laboratory. Pyuria: white blood cell (WBC) count within normal limit of central laboratory. Cylindruria: No RBC or WBC casts. Day 1 (randomization) to 12 months. No
Secondary Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period CRR defined as meeting all of 5 criteria. RF: (Glomerular filtration rate [GFR] calculated using MDRD equation) Calculated function abnormal at screening visit - return of renal function to greater than or equal to 90% of function at approximately 6 months prior to onset of the current episode of lupus nephritis. Calculated function normal at screening visit - estimated renal function 90% or greater of level at screening visit. Proteinuria: urinary protein/creatinine ratio <30 mg/mmol. Hematuria: red blood cell (RBC) count within normal limits of Central Laboratory. Pyuria: White blood cell count (WBC) within normal limits of Central Laboratory. Cylindruria: No RBC or WBC casts reported. At Month 12 from Day 1 No
Secondary Number of Months CRR Was Maintained During Short-term Period Durability of CRR, defined as the number of months (number of consecutive planned visits beyond Day 15) a participant met the definition of CRR during the double-blind treatment period. Refer to outcome 1 for description of CRR. Day 1 (randomization) to 12 Months No
Secondary Baseline Renal Function Over Time During Short-term Period Baseline (BL) renal function, as estimated by calculation of the MDRD (Modification of Diet in Renal Disease) equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A negative value indicates worsening. Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 No
Secondary Change in Renal Function From Baseline Over Time During Short-term Period Mean change from baseline in renal function, as estimated by calculation of the MDRD equation, over time. Renal MDRD is an equation (calculation) used to estimate Glomerular Filtration Rate (GFR) in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. A positive value indicates improvement. Change from baseline=Post-baseline-baseline value. Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365 No
Secondary Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as =1. The total maximum score is 48, and increasing score indicates increasing disease severity. Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose) No
Secondary Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period RR is defined as meeting BOTH of the following criteria:RENAL FUNCTION: Less than or equal to 25% increase from baseline;PROTEINURIA: Greater than or equal to 50% improvement in the urine protein/creatinine ratio with one of the following - urine protein/creatinine ratio (UPCR) <113 mg/mmol,, if the baseline ratio was <=339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio > 339 mg/mmol. A participant was considered as achieving RR if response criteria at both months 11 and 12 (Days 337 and 365, respectively) were met. For 95% CI within each group, normal approximation is used if n>=5. Month 12 No
Secondary Change in SLICC/ACR Damage Index From Baseline During Short-term Period SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as non-reversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. A score of 0=no damage, early damage is defined as =1. The total maximum score is 48, and increasing score indicates increasing disease severity. Change from baseline=Postbaseline - baseline value. Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose) No
Secondary Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. Baseline (Day 1), Days 85, 169, 253, and 365 No
Secondary Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. Baseline (Day 1), Days 85, 169, 253, and 365 No
Secondary Baseline Mental Component Summary of the Short SF-36 During Short-term Period The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. Baseline (Day 1), Days 85, 169, 253, and 365 No
Secondary Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value. Baseline (Day 1), Days 85, 169, 253, and 365 No
Secondary Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period A visual analogue scale (VAS) is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured. The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue. Baseline (Day 1), Days 85, 169, 253, and 365 No
Secondary Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period A visual analogue scale is a psychometric response scale for measurement of subjective characteristics or attitudes that cannot be directly measured.
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on 1 end and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Baseline (Day 1), Days 85, 169, 253, and 365 No
Secondary Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue. Baseline (Day 1), Days 85, 169, 253, and 365 No
Secondary Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period The reduction of fatigue assessed by Fatigue Severity Scale (FSS). The FSS questionnaire is comprised of 9 statements inquiring about the examinee's sleep habits over the preceding week. Participants are asked to rate their level of agreement (toward seven) or disagreement (toward zero) with the nine statements. A score of 36 and above (out of a maximum of 63) indicates the presence of significant fatigue. Baseline (Day 1), Days 85, 169, 253, and 365 No
Secondary Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug. From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first. Yes
Secondary Participants With AEs of Special Interest During the Short-term Period AEs of special interest were prospectively identified to be those that may be associated with the use of immunomodulatory agents. They are a subset of all AEs and may be either serious or non-serious. From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first. Yes
Secondary Participants With Marked Hematology Abnormalities During the Short-term Period LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. Low(?)Hemoglobin:>3g/dL decrease from PTV; ?Hematocrit:<0.75xPTV;?Erythrocyte count:<0.75xPTV; high(?)Platelet count:>1.5xULN;?Platelet count:<0.67xLLN;?Leukocyte count:<0.75X LLN;?Leukocyte count:>1.25xULN;?Absolute(AB)Neutrophils+Bands:<1.00x10^3c/uL;?AB Lymphocyte count:>7.50x10^3 c/uL; ?AB lymphocyte count:<0.750x10^3 c/uL;?AB monocyte count:>2000/mm^3;?AB basophil count:>400/mm^3;?AB eosinophil count:>0.750x10^3 c/uL. From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first. Yes
Secondary Participants With Marked Laboratory Abnormalities During the Short-term Period LLN=lower limit of normal; ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age. ?Serum Sodium:>1.05x ULN;?Serum Potassium:<0.9x LLN;?Serum Potassium:>1.1x ULN;?Total Calcium:<0.8X LLN;?Total Calcium:>1.2x ULN; ?Serum Glucose(SG):<65 mg/dL;?SG:>220 mg/dL;?Fasting SG:<0.8x LLN;?Fasting SG:>1.5x ULN;?Total Protein:<0.9x LLN;?Albumin:<0.9x LLN;?Total Cholesterol:>2x PTV;?Triglycerides:>=2.5x ULN;?Fasting Triglycerides:>=2x ULN From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first. Yes
Secondary Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period ULN=upper limit of normal; PTV=pretreatment value. Normal ranges are provided by the Central Laboratory and may vary according to sex and age.
Alkaline Phosphatase:>2x ULN; ?Aspartate Aminotransferase: >3x ULN; ?Alanine Aminotransferase : >3x ULN; G-Glutamyl Transferase : >2x ULN; ?Total Bilirubin : >2x ULN or if PTV > ULN then > 4x PTV; ?Blood Urea Nitrogen >2x PTV; ?Creatinine >1.5x PTV.
From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first. Yes
Secondary Participants With Marked Abnormalities Urinalysis During the Short-term Period PTV=pretreatment value. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase , if missing PTV then use >=2+ (or, if value >=4, or if PTV=0 or 0.5, >=2 or if PTV=1, >=3, or if PTV=2 or 3, >=4). From Baseline (Day 1) up to 56 days post last dose in the double-blind period or the first dose in the open-label long-term extension, whichever occurred first. Yes
Secondary Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP) 0 - 12 Months Yes
Secondary Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP) 0 - 12 Months Yes
Secondary Vital Signs Summary During the Short-term Period: Heart Rate 0 - 12 Months Yes
Secondary Vital Signs Summary During the Short-term Period: Temperature 0 - 12 Months Yes
Secondary Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period A validated, sensitive electrochemiluminescence (ECL) immunoassay based on Meso-Scale Discovery instrumentation was used to evaluate immunogenicity. The ECL assay differentiated between two antibody specificities: (1) the 'Ig and/or Junction (Jn) Region' and (2) 'CLTA4 and possibly Ig'. A sample was considered positive if it had a titer of 10 or greater and if immunodepletion was observed with abatacept with or without CTLA4-T. Day 169, Day 365 Yes
Secondary Baseline Quantitative Immunoglobulins During the Short-term Period A quantitative immunoglobulins (Igs) test is used to detect abnormal levels of the three major classes of Igs (IgG, IgA, and IgM). Abnormal test results typically indicate that there is something affecting the immune system which requires further testing. Baseline (Day 1) Yes
Secondary Change in Quantitative Immunoglobulin From Baseline During Short-term Period A quantitative immunoglobulin (Ig) test is used to detect abnormal levels of the 3 major classes of Ig (IgG, IgA, and IgM). Abnormal test results typically indicate that something is affecting the immune system and further testing is required.
Please refer to Outcome 31 for the respective baseline values
Day 365 Yes
Secondary Number of Participants Achieving Complete Response by ACCESS Definition The Abatacept and Cyclophosphamide Combination Efficacy and Safety Study (ACCESS) defines complete response as a response meeting all of the following criteria: serum creatinine =upper limit of normal as defined by the central laboratory or =125% of the higher value at either screening or baseline; urine protein/creatinine ratio <50 mg/mmoL; and prednisone or prednisone-equivalent dose tapered to 10 mg per day. End of short-term period (Day 365) to termination of the long-term extension period No
Secondary Number of Participants Achieving Patient Response of Complete or Partial Response, Based on the June 2010 Food and Drug Administration Guidance Document for Lupus Nephritis Patient response=complete, partial, or no response. Complete response=serum creatinine (SCr) normal, inactive urinary sediment, no cellular casts, urinary protein/creatinine (UPCR) ratio<56.5 mg/mmol. Partial response=SCr normal or =25% above baseline value, RBCs at reference range, UPCR <56.5 mg/mmoL OR =50% improvement in UPCR with one of the following: UPCR <113 or <339 mg/mmoL, based on the baseline ratio. No response=Not achieving complete or partial response criteria. At Day 365 (end of Short-term Period) and Day 645 No
Secondary Mean Change From Baseline in SLICC/ACR Damage Index SLICC=Systemic Lupus International Collaborating Clinics; ACR=American College of Rheumatology. The SLICC/ACR Damage Index measures organ damage (nonreversible change, unrelated to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months unless otherwise stated. The index assesses 47 items in 12 systems: Ocular, Neuropsychiatric, Renal, Pulmonary, Cardiovascular, Gastrointestinal, Peripheral Vascular, Musculoskeletal, Skin, Premature Gonadal Failure, Diabetes, Malignancy. Scores range from 0 to 2, and the same lesion cannot be scored twice. If damage is noted for a particular item, it is scored 1. No damage is scored 0. Some items may score 2 points if they occur more than once, so that the maximum possible score is 47. Scores can only increase with time, but scores rarely reach over 12. It is usually completed (or updated) yearly. Day 365 to termination of the long-term extension phase No
Secondary Number of Participants With Death, Serious Adverse Events (SAE), Treatment-related Adverse Events SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs During Long-term Extension Period AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=possibly, probably, or certainly related to and of unknown relationship to study drug. From start of study drug in long-term period (Day 365) to up to 56 days after the last dose of the long-term extension (LTE). Deaths in LTE reported to >56 days post last dose. Yes
Secondary Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period Collected in at least 1 sample. Assessment includes immunogenicity (detection of serum antibodies which bind to CTLA4-Ig in the in vitro assays) and exposure to corticosteroids Day 365 to end of long-term extension period No
Secondary Number of Participants Achieving Renal Response Renal response=serum creatinine level =25% above baseline value and greater than or equal to 50% improvement in the urine protein/creatinine ratio with 1 of the following: urine protein/creatinine ratio (UPCR) <113 mg/mmol, if the baseline ratio was <= 339 mg/mmol OR UPCR <339 mg/mmol,if the baseline ratio >339 mg/mmol. At Day 365 (end of short-term period) and Day 645 No
Secondary Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Hemoglobin (g/dL): >3g/dL decrease from preRX value. Hematocrit(%): <0.75*preRX. Erythrocytes (*10^6 c/uL): <0.75*preRX. Platelet count (*10^9 c/L): <0.67*LLN, or >1.5*ULN, or if preRX From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period Yes
Secondary Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Sodium, serum (mEq/L): <0.95*LLN or >1.05*ULN, or if preRX From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period Yes
Secondary Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued) preRX=pretreatment. Protein, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 OR 3 then use >=4. Glucose, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Blood, urine: If missing preRX, use >=2, or if value >=4, or if preRX =0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. Leukocyte esterase, urine: If missing preRX, use >=2, or if value >=4, or if preRX=0 or 0.5, use >=2, or if preRX=1, use >=3, or if preRX=2 or 3, use >=4. From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period Yes
See also
  Status Clinical Trial Phase
Terminated NCT03843125 - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE) Phase 3
Recruiting NCT05698173 - Systemic Lupus Erythematosus and Accelerated Aging N/A
Active, not recruiting NCT01649765 - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy Phase 2
Recruiting NCT05704153 - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A) N/A
Completed NCT05048238 - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus Phase 1
Recruiting NCT06056778 - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed NCT04358302 - Individual Patient Exposure and Response in Pediatric Lupus N/A
Completed NCT03802578 - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients N/A
Completed NCT02554019 - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus Phase 2
Recruiting NCT04835883 - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients Phase 2
Terminated NCT02665364 - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus Phase 2
Completed NCT00278538 - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus Phase 2
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT03252587 - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus Phase 2
Terminated NCT02066311 - Nelfinavir in Systemic Lupus Erythematosus Phase 2
Recruiting NCT01892748 - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus. N/A
Terminated NCT01689025 - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) Phase 1
Completed NCT01475149 - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE) N/A
Unknown status NCT01712529 - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients N/A
Completed NCT00962832 - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus Phase 2