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Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

2015年3月3日 更新者：Bristol-Myers Squibb

A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)

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.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

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

研究の種類

介入

入学 (実際)

423

段階

  • フェーズ2
  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson、Arizona、アメリカ、85724
        • Arizona Arthritis Center
    • California
      • Los Angeles、California、アメリカ、90048
        • Wallace Rheumatic Study Center
    • Kansas
      • Kansas City、Kansas、アメリカ、66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02118
        • Boston University School of Medicine
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55415
        • Hennepin County Medical Center
    • New York
      • Brooklyn、New York、アメリカ、11203
        • SUNY Downstate Medical Center
      • Lake Success、New York、アメリカ、11042
        • Northshore Lij Health System
      • Manhasset、New York、アメリカ、11030
        • The Feinstein Institute for Medical Research
      • Syracuse、New York、アメリカ、13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27599
        • University of North Carolina at Chapel Hill
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73104
        • Ok Medical Research Foundation
    • Tennessee
      • Knoxville、Tennessee、アメリカ、37909
        • Rheumatology Consultants Pllc
    • Washington
      • Seattle、Washington、アメリカ、98101
        • Virginia Mason Medical Center
  • アルゼンチン
      • Cordoba、アルゼンチン、5016
        • Local Institution
      • Tucuman、アルゼンチン、4000
        • Local Institution
    • Buenos Aires
      • Capital Federal、Buenos Aires、アルゼンチン、1015
        • Local Institution
      • Ciudad Autonoma De Buenos Aire、Buenos Aires、アルゼンチン、1055
        • Local Institution
  • イギリス
    • Cambridgeshire
      • Cambridge、Cambridgeshire、イギリス、CB2 2QQ
        • Local Institution
    • Greater London
      • London、Greater London、イギリス、SE1 7EX
        • Local Institution
  • インド
      • Hyderabad、インド、500082
        • Local Institution
      • Visakhapatnam、インド、530002
        • Local Institution
    • Ahmedabad
      • Gujarat、Ahmedabad、インド、380016
        • Local Institution
    • Andhra Pradesh
      • Secunderabad、Andhra Pradesh、インド、500003
        • Local Institution
    • Gujarat
      • Ahmedabad、Gujarat、インド、380 007
        • Local Institution
      • Nadiad、Gujarat、インド、387001
        • Local Institution
    • Karnataka
      • Bangalore、Karnataka、インド、560 034
        • Local Institution
      • Bangalore、Karnataka、インド、560 017
        • Local Institution
    • Kerala
      • Kochi、Kerala、インド、682026
        • Local Institution
    • Maharajhsra
      • Mumbai、Maharajhsra、インド、400064
        • Local Institution
  • オーストラリア
    • New South Wales
      • Liverpool、New South Wales、オーストラリア、2170
        • Local Institution
    • Victoria
      • Clayton、Victoria、オーストラリア、3168
        • Local Institution
      • Heidelberg、Victoria、オーストラリア、3084
        • Local Institution
      • Parkville、Victoria、オーストラリア、3050
        • Local Institution
  • カナダ
      • Quebec、カナダ、G1R 2J6
        • Local Institution
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 2S2
        • Local Institution
    • Manitoba
      • Winnipeg、Manitoba、カナダ、R3A 1M4
        • Local Institution
    • Ontario
      • Toronto、Ontario、カナダ、M5T 2S8
        • Local Institution
  • フランス
      • Creteil Cedex、フランス、94010
        • Local Institution
      • Paris Cedex 13、フランス、75651
        • Local Institution
      • Strasbourg Cedex、フランス、67098
        • Local Institution
      • Toulouse Cedex 4、フランス、31403
        • Local Institution
  • ブラジル
      • Rio De Janeiro、ブラジル、20551
        • Local Institution
      • Sao Paulo、ブラジル、04026
        • Local Institution
    • Goias
      • Goiania、Goias、ブラジル、74110
        • Local Institution
    • Parana
      • Curitiba、Parana、ブラジル、80060
        • Local Institution
    • Rio Grande Do Sul
      • Porto Alegre、Rio Grande Do Sul、ブラジル、91610
        • Local Institution
  • ベルギー
      • Bruxelles、ベルギー、1200
        • Local Institution
      • Leuven、ベルギー、3000
        • Local Institution
  • ポーランド
      • Bydgoszcz、ポーランド、85-094
        • Local Institution
      • Gdansk、ポーランド、80-952
        • Local Institution
      • Wroclaw、ポーランド、50-417
        • Local Institution
  • メキシコ
      • Aguascalientes、メキシコ、20000
        • Local Institution
      • San Luis Potosi、メキシコ、78240
        • Local Institution
    • Distrito Federal
      • Mexico City、Distrito Federal、メキシコ、06726
        • Local Institution
    • Estado De Mexico
      • Metepec、Estado De Mexico、メキシコ、52140
        • Local Institution
    • Jalisco
      • Guadalajara、Jalisco、メキシコ、44100
        • Local Institution
      • Guadalajara、Jalisco、メキシコ、44690
        • Local Institution
    • Nuevo Leon
      • Monterrey、Nuevo Leon、メキシコ、64020
        • Local Institution
    • Yucatan
      • Merida、Yucatan、メキシコ、97000
        • Local Institution
  • ロシア連邦
      • Ekaterinburg、ロシア連邦、620102
        • Local Institution
      • Moscow、ロシア連邦、115522
        • Local Institution
      • Yaroslaval、ロシア連邦、150062
        • Local Institution
  • 七面鳥
      • Gaziantep、七面鳥、27310
        • Local Institution
  • 中国
    • Beijing
      • Beijing、Beijing、中国、100034
        • Local Institution
      • Beijing、Beijing、中国、100730
        • Local Institution
      • Beijing、Beijing、中国、100044
        • Local Institution
      • Beijing、Beijing、中国、100853
        • Local Institution
    • Guangdong
      • Guangzhou、Guangdong、中国、510080
        • Local Institution
    • Shanghai
      • Shanghai、Shanghai、中国、200025
        • Local Institution
      • Shanghai、Shanghai、中国、200001
        • Local Institution
    • Shanxi
      • Xi'an、Shanxi、中国、710032
        • Local Institution
  • 南アフリカ
    • Gauteng
      • Johannesburg、Gauteng、南アフリカ、2013
        • Local Institution
    • Western Cape
      • Observatory、Western Cape、南アフリカ、7925
        • Local Institution
      • Panorama、Western Cape、南アフリカ、7500
        • Local Institution
  • 台湾
      • Kaohsiung、台湾、833
        • Local Institution
      • Taichung、台湾、402
        • Local Institution
      • Taichung、台湾、407
        • Local Institution
      • Taipei、台湾、11217
        • Local Institution
      • Taoyuan、台湾、333
        • Local Institution
  • 大韓民国
      • Seoul、大韓民国、110-744
        • Local Institution
      • Seoul、大韓民国、137-040
        • Local Institution
    • Sungdong-Gu
      • Seoul、Sungdong-Gu、大韓民国、133-792
        • Local Institution
  • 香港
      • Hong Kong、香港
        • Local Institution

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Abatacept 30 mg/kg+Corticosteroids+MMF
Short-term Period
薬：Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily
薬：Abatacept
intravenous solution, injectable, 30 mg/kg, every 28 days
他の名前：
  • オレンシア
  • BMS-188667
薬：Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days
他の名前：
  • オレンシア
  • BMS-188667
薬：Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily
実験的：Abatacept 10 mg/kg+Corticosteroids+MMF
Short-term Period
薬：Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily
薬：Abatacept
intravenous solution, injectable, 30 mg/kg, every 28 days
他の名前：
  • オレンシア
  • BMS-188667
薬：Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days
他の名前：
  • オレンシア
  • BMS-188667
薬：Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily
実験的：Placebo+Corticosteroids+MMF
Short-term Period
薬：Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily
薬：Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily
実験的：Abatacept 10mg/kg
Long-term Extension Period
薬：Abatacept
intravenous solution, injectable, 30 mg/kg, every 28 days
他の名前：
  • オレンシア
  • BMS-188667
薬：Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days
他の名前：
  • オレンシア
  • BMS-188667

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period
時間枠：Day 1 (randomization) to 12 months.
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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With Confirmed Complete Renal Response (CRR) During Short-term Period
時間枠：Day 1 to 12 months
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
Participants Achieving a Confirmed Complete Renal Response (CRR) at Month 12 During Short-term Period
時間枠：At Month 12 from Day 1
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
Time to Achieve First Confirmed Renal Improvement (RI) During Short-term Period (as Determined by Kaplan-Meier Methodology)
時間枠：Day 1 (randomization) to 12 months.
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.
Participants Achieving Renal Improvement (RI) or CRR at Month 12 During Short-term Period
時間枠：At Month 12 from Day 1
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
Number of Months CRR Was Maintained During Short-term Period
時間枠：Day 1 (randomization) to 12 Months
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
Baseline Renal Function Over Time During Short-term Period
時間枠：Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
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
Change in Renal Function From Baseline Over Time During Short-term Period
時間枠：Baseline (Day 1), Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365
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
Baseline and Post Baseline Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index During Short-term Period
時間枠：Baseline (Day 1), Post baseline (Month 12 or 28 days after last dose)
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)
Number of Participants Achieving Renal Response (RR) at Month 12 During Short-term Period
時間枠：Month 12
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
Change in SLICC/ACR Damage Index From Baseline During Short-term Period
時間枠：Baseline (Day 1), Postbaseline (Month 12 or 28 days after last dose)
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)
Baseline Physical Component Summary of the Short Form (SF)-36 During Short-term Period
時間枠：Baseline (Day 1), Days 85, 169, 253, and 365
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
Change From Baseline in Physical Component Summary of the SF-36 During Short-term Period
時間枠：Baseline (Day 1), Days 85, 169, 253, and 365
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
Baseline Mental Component Summary of the Short SF-36 During Short-term Period
時間枠：Baseline (Day 1), Days 85, 169, 253, and 365
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
Change From Baseline in Mental Component Summary of the SF-36 During Short-term Period
時間枠：Baseline (Day 1), Days 85, 169, 253, and 365
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
Baseline Fatigue as Measured by the Fatigue Visual Analog Scale During Short-term Period
時間枠：Baseline (Day 1), Days 85, 169, 253, and 365
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
Change in Fatigue From Baseline as Measured by the Fatigue Visual Analog Scale During Short-term Period
時間枠：Baseline (Day 1), Days 85, 169, 253, and 365

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
Baseline Fatigue as Measured by Fatigue Severity Scale-Krupp During Short-term Period
時間枠：Baseline (Day 1), Days 85, 169, 253, and 365
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
Change in Fatigue From Baseline as Measured by Fatigue Severity Scale-Krupp During Short-term Period
時間枠：Baseline (Day 1), Days 85, 169, 253, and 365
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
Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs Reported During the Short-term Period
時間枠：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.
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.
Participants With AEs of Special Interest During the Short-term Period
時間枠：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.
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.
Participants With Marked Hematology Abnormalities During the Short-term Period
時間枠：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.
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.
Participants With Marked Laboratory Abnormalities During the Short-term Period
時間枠：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.
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.
Participants With Marked Liver and Kidney Function Abnormalities During the Short-term Period
時間枠：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.

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.
Participants With Marked Abnormalities Urinalysis During the Short-term Period
時間枠：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.
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.
Vital Signs Summary During the Short-term Period: Systolic Blood Pressure (SBP)
時間枠：0 - 12 Months
0 - 12 Months
Vital Signs Summary During the Short-term Period: Diastolic Blood Pressure (DBP)
時間枠：0 - 12 Months
0 - 12 Months
Vital Signs Summary During the Short-term Period: Heart Rate
時間枠：0 - 12 Months
0 - 12 Months
Vital Signs Summary During the Short-term Period: Temperature
時間枠：0 - 12 Months
0 - 12 Months
Number of Participants With Positive Abatacept-induced Responses (ECL Method) Over Time During the Short-term Period
時間枠：Day 169, Day 365
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
Baseline Quantitative Immunoglobulins During the Short-term Period
時間枠：Baseline (Day 1)
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)
Change in Quantitative Immunoglobulin From Baseline During Short-term Period
時間枠：Day 365

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
Number of Participants Achieving Complete Response by ACCESS Definition
時間枠：End of short-term period (Day 365) to termination of the long-term extension period
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
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
時間枠：At Day 365 (end of Short-term Period) and Day 645
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
Mean Change From Baseline in SLICC/ACR Damage Index
時間枠：Day 365 to termination of the long-term extension phase
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
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
時間枠：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.
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.
Number of Participants With a Treatment-emergent Seropositive Result During the Long-term Extension Period
時間枠：Day 365 to end of 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
Number of Participants Achieving Renal Response
時間枠：At Day 365 (end of short-term period) and Day 645
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
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period
時間枠：From start of study drug on Day 365 up to 56 days after last dose in 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 <LLN, use <0.5*preRX and <100,000/mm^3. Leukocytes (*10^3 c/uL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8* preRX or >ULN; if preRX>ULN, use >1.2*preRX or <LLN. Neutrophils + Bands (absolute) (*10^3 c/uL): If value <1.0*10^3 or if value >7.50*10^3 c/uL. Monocytes (absolute) (*10^3 c/uL): If value >2000/mm^3. Basophils (absolute)(*10^3 c/uL): If value >.750*10^3 c/uL. Eosinophils (absolute) (*10^3 c/uL): If value >.750*10^3 c/uL. ALP (U/L): >2*ULN, or if preRX>ULN, use >3* preRX. AST (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. ALT (U/L): >3*ULN, or if preRX>ULN, use >4*preRX. GGT (U/L):>2*ULN, or if preRX >ULN, use >3*preRX. Bilirubin, total (mg/dL): >2*ULN, or if preRX>ULN, use >4*preRX. BUN (mg/dL): >1.5*preRX.
From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
時間枠：From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
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<LLN, use <0.95*preRX or >ULN if preRX>ULN, use >1.05*preRX or <LLN. Potassium, serum (mEq/L): <0.9* LLN or >1.1*ULN, or if preRX <LLN, use <0.9*preRX or >ULN if preRX>ULN, use >1.1*preRX or <LLN. Chloride, serum (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN. Calcium, total (mg/dL): <0.8*LLN or >1.2*ULN, or if preRX<LLN, use <0.75*preRX or >ULN if preRX>ULN, use >1.25*preRX or <LLN. Glucose, serum (mg/dL): <65 mg/dL, or >220 mg/dL. Glucose, fasting serum (mg/dL): <0.8*LLN or >1.5*ULN, or if preRX <LLN, use <0.8*preRX or >ULN if preRX>ULN, use >2.0*preRX or <LLN. Albumin (g/dL): <0.9*LLN, or if preRX <LLN, use <0.75*preRX. Cholesterol, total (mg/dL): >2*preRX. Triglycerides (mg/dL): >=2.5*ULN, or if preRX>ULN, use >=2.5*preRX. Triglycerides, fasting (mg/dL): >=2*ULN, or if preRX>ULN, use >2.0*preRX.
From start of study drug on Day 365 up to 56 days after last dose in the long-term extension period
Number of Participants With Marked Laboratory Abnormalities During the Long-term Extension Period (Continued)
時間枠：From start of study drug on Day 365 to up to 56 days after last dose in the long-term extension period
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

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of Participants Achieving Patient Response (PR) at Month 12 During the Short-term Period
時間枠：Month 12

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Bristol-Myers Squibb

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2007年6月1日

一次修了 (実際)

2010年9月1日

研究の完了 (実際)

2011年8月1日

試験登録日

最初に提出

2007年2月1日

QC基準を満たした最初の提出物

2007年2月1日

最初の投稿 (見積もり)

2007年2月2日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年3月20日

QC基準を満たした最後の更新が送信されました

2015年3月3日

最終確認日

2015年3月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • IM101-075

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