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Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

Primary Purpose

Lupus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-931699
Placebo matching BMS-931699
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lupus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Male or female aged between 18 to 70 (included)
  • Diagnosed with active systemic lupus erythematosus by a doctor
  • Disease must be in patient's joints or on the skin at a minimum
  • Taking other medications is allowed but some are excluded

Exclusion Criteria:

  • Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
  • Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus

Sites / Locations

  • Rheumatology Associates Of North Alabama, P.C.
  • St Jude Hospital Yorba Linda
  • Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
  • Harbor UCLA Medical Center
  • University Of Connecticut Health Center
  • Local Institution
  • Center For Rheumatology, Immunology And Arthritis
  • The Arthritis Center
  • Jefrey D. Lieberman, Md., Pc
  • Coeur D'Alene Arthrit Clin
  • Heartland Research Associates, Llc
  • Beth Israel Deaconess Med. Center Div. Of Gastroenterology
  • Physician Research Collaboration, Llc
  • Albuquerque Clinical Trials
  • North Shore Lij Health System
  • The Feinstein Institute For Medical Research
  • The University of North Carolina at Chapel Hill
  • Joint and Muscle Medical Care and Research Institute (JMMCRI)
  • Pmg Research Of Salisbury
  • Oklahoma Medical Research Foundation
  • East Penn Rheumatology Associates, P.C.
  • Allegheny-Singer Research Institute (Asri)
  • Tekton Research Inc
  • Local Institution
  • Arthritis Northwest
  • Local Institution
  • Hospital General De Agudos J.M. Ramos Mejia
  • Instituto De Investigaciones Clinicas De Mar Del Plata
  • Instituto de Asistencia Reumatologica Integral
  • Clinica De Reumatologia
  • Centro Consultora Integral de Salud SRL
  • Servicos Especializados em Reumatologia SER
  • Cip Pesquisas Medicas
  • Centro Mineiro De Pesquisa
  • Centro Medico Varginha
  • Edumed - Educacao em Saude S/S LTDA
  • LMK Servicos Medicos S S Ltda
  • CPCLIN Centro de Pesquisas Clinicas LTDA
  • Lar Escola AACD
  • Karma Clinical Trials Inc.
  • McMaster University
  • Toronto Western Hospital, University Health Network
  • Centre De Recherche Musculo-Squelettique
  • CHU de Quebec Research Centre
  • Centro De Estudios Reumatologicos
  • Hospital San Borja Arriaran
  • Riesgo De Fractura
  • Servimed E.U
  • Clinica De La Costa
  • Hospital Pablo Tobon Uribe
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Campus Charite Mitte
  • Medizinsche Universitaetsklinik Freiburg
  • Universitaetshautklinik Heidelberg
  • Johannes Gutenberg - Universitaet
  • Budai Irgalmasrendi Korhaz
  • Infektologiai-Hepatologiai Osztaly
  • Borgyogyaszati Klinika
  • Arcispedale S. Anna
  • Azienda Ospedaliera Luigi Sacco
  • Azienda Ospedaliera Di Padova
  • Azienda Ospedaliera Universitaria Pisana
  • Policlinico Umberto I
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
  • Instituto para el DeSarrollo Integral de la Salud S de RL de CV
  • Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia
  • Centro Integral En Reumatologia Sa De Cv
  • Clinica de Investigacion en Reumatologia y Obesidad S.C.
  • Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.
  • Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.
  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
  • Unidad Reumatologica Las Americas, S.C. P.
  • Local Institution
  • Local Institution
  • Clinica Anglo Americana
  • Hospital Nacional Cayetano Heredia
  • Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
  • Local Institution
  • Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar
  • Local Institution
  • Local Institution
  • Sf. Maria Clinical Hospital,Bucharest
  • Spitalul Clinic de Recuperare Iasi
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Hosp Univer 12 De Octubre
  • Hospital Carlos Haya De Malaga
  • Hospital Meixoeiro
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental:Arm A: BMS-931699

Experimental:Arm B: BMS-931699

Experimental:Arm C: BMS-931699

Experimental:Arm D: BMS-931699

Placebo Comparator: Arm E: Placebo matching BMS-931699

Arm Description

12.5mg subcutaneous (SC) injection Weekly dosing

12.5mg SC injection Every other Week dosing

5mg SC injection Every other Week dosing

1.25mg SC injection Every other Week dosing

0mg SC injection Weekly dosing

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169
The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline.

Secondary Outcome Measures

Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169
SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85
SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)
Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85
BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol.
Mean Change From Baseline in CLASI Score at Day 85 and Day 169
Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.
Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score
Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.
Change From Baseline in Arthritis, as Assessed by American College of Rheumatology (ACR) 28-joint Count of Tender and Swollen Joints on Day 85 and Day 169
Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0-9.4). The level of RA disease activity can be interpreted as low (DAS28 <=3.2),moderate (3.2 < DAS28 <=5.1), or as high disease activity (DAS28 > 5.1)
Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169
Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never 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.
Cumulative Corticosteroid and Immunosuppressant Use
Percent of participants requiring use of corticosteroids and mmunosuppressants use over time
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions
Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate
HEART RATE (HR) Beats per min (BPM): HR > 100 AND CHANGE FROM BASELINE > 30 OR HR < 55 AND CHANGE FROM BASELINE < -15
Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
SYSTOLIC BLOOD PRESSURE (SYSBP) (MMHG); SYSBP > 140 AND CHANGE FROM BASELINE > 20 OR SYSBP < 90 AND CHANGE FROM BASELINE < -20; DIASTOLIC BLOOD PRESSURE (DIABP) > 90 AND CHANGE FROM BASELINE > 10 OR DIABP < 55 AND CHANGE FROM BASELINE < -10;
Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate
RESPIRATION RATE (RESP) (PER MIN) RESP > 16 OR RESP CHANGE FROM BASELINE > 10
Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature
TEMPERATURE (TEMP) (C) TEMP > 38.3 OR TEMP CHANGE FROM BASELINE > 1.6
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF
Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified
Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Ctrough = Trough level serum concentration of BMS-931699 at time point specified Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data.
Serum Biomarkers C3, C4
Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169. No anti-dsDNA data was available for this report
Short Term: Receptor Occupancy Over Time
Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy
Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified
Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period.
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN G/L L < 0.85×PRE-RX; HEMATOCRIT VOL L < 0.85×PRE-RX; PLATELET COUNT X10*9 C/L H > 1.5×ULN (ULN = Upper Limit of Normal) IF PRE-RX IS MISSING OR > 1.5×ULN PLATELET COUNT X10*9 C/L L < 0.85×LLN (LLN = Lower Limit of Normal) IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >= LLN OR < 0.85×PRE-RX IF PRE-RX < LLN; ERYTHROCYTES RBC X10*12 C/L L < 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES X10*9 C/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF LLN <= PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; LEUKOCYTES WBC X10*9 C/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF LLN <= PRE-RX <= ULN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) X10*9 C/L H > 0.4; BLASTS (ABSOLUTE) X10*9 C/L H > 0; EOSINOPHILS (ABSOLUTE) EOSA X10*9 C/L H > 0.75; LYMPHOCYTES (ABSOLUTE) X10*9 C/L H > 7.5; LYMPHOCYTES (ABSOLUTE) X10*9 C/L L < 0.75; MONOCYTES (ABSOLUTE) X10*9 C/L H > 2; NEUTROPHILS (ABSOLUTE) X10*9 C/L L < 1.5 IF PRE-RX IS MISSING OR < 1.5 IF PRE-RX >= 1.5 OR < 0.85×PRE-RX IF PRE-RX < 1.5; COAGULATION activated Partial thromboplastin time (APTT) SEC H > 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H > 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H > 1.5×ULN
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H > 1.15×ULN IF PRE-RX IS MISSING OR > 1.15×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN BILIRUBIN, TOTAL UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN CREATININE UMOL/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.33×PRE-RX IF PRE-RX > ULN GLOMERULAR FILTRATION RATE, CALC. ML/S/M*2 L < 0.8×PRE-RX; UREA UREA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1
CALCIUM, TOTAL MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CALCIUM, TOTAL MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; CHLORIDE, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CHLORIDE, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN;
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
BICARBONATE MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; BICARBONATE MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; POTASSIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; POTASSIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; MAGNESIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN MAGNESIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3
SODIUM, SERUM MMOL/L H > 1.05×ULN IF PRE-RX IS MISSING OR > 1.05×ULN IF PRE-RX <= ULN OR > 1.05×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN SODIUM, SERUM MMOL/L L < 0.95×LLN IF PRE-RX IS MISSING OR < 0.95×LLN IF PRE-RX >= LLN OR < 0.95×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >=LLN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
GLUCOSE TESTS:GLUCOSE, FASTING SERUM MMOL/L H > 1.3×ULN IF PRE-RX IS MISSING OR > 1.3×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN GLUCOSE, FASTING SERUM MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; PROTEIN TESTS:ALBUMIN G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN PROTEIN, TOTAL G/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PROTEIN, TOTAL G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN TRIGLYCERIDES, FASTING MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN PANCREATIC TESTS: AMYLASE, TOTAL U/L H > 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) U/L H > 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) U/L H > 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM NMOL/L L < 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN; TROPONIN-I, CARDIAC SPECIFIC UG/L H > ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY
IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H > 1.5×ULN; CRP, HIGH SENSITIVITY MG/L H > 1.5×ULN;
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
QUALITATIVE URINE CHEMISTRY: BLOOD, URINE N/A H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 GLUCOSE, URINE N/A H >= 1 IF PRE-RX IS MISSING OR >= 1 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 PROTEIN, URINE UNKNOWN H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2 WBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2
Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169
Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The SLEDAI-2K score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169
Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very good and 100 mm = very bad.

Full Information

First Posted
October 15, 2014
Last Updated
October 3, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02265744
Brief Title
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
Official Title
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 13, 2014 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.
Detailed Description
Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period The LTE period will remain blinded but will no longer have a placebo arm: Subjects will remain on their originally assigned treatment arm unless they were on placebo Subjects initially randomized to placebo arm will be automatically re-randomized into one of the existing active arms at Day 169 (24 weeks)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
730 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental:Arm A: BMS-931699
Arm Type
Experimental
Arm Description
12.5mg subcutaneous (SC) injection Weekly dosing
Arm Title
Experimental:Arm B: BMS-931699
Arm Type
Experimental
Arm Description
12.5mg SC injection Every other Week dosing
Arm Title
Experimental:Arm C: BMS-931699
Arm Type
Experimental
Arm Description
5mg SC injection Every other Week dosing
Arm Title
Experimental:Arm D: BMS-931699
Arm Type
Experimental
Arm Description
1.25mg SC injection Every other Week dosing
Arm Title
Placebo Comparator: Arm E: Placebo matching BMS-931699
Arm Type
Placebo Comparator
Arm Description
0mg SC injection Weekly dosing
Intervention Type
Drug
Intervention Name(s)
BMS-931699
Other Intervention Name(s)
lulizumab pegol
Intervention Type
Drug
Intervention Name(s)
Placebo matching BMS-931699
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169
Description
The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline.
Time Frame
At Day 169
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169
Description
SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)
Time Frame
At Day 169
Title
Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85
Description
SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)
Time Frame
At Day 85
Title
Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85
Description
BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol.
Time Frame
At Day 85
Title
Mean Change From Baseline in CLASI Score at Day 85 and Day 169
Description
Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.
Time Frame
At Day 85 and Day 169
Title
Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score
Description
Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.
Time Frame
At Day 85 and Day 169
Title
Change From Baseline in Arthritis, as Assessed by American College of Rheumatology (ACR) 28-joint Count of Tender and Swollen Joints on Day 85 and Day 169
Description
Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0-9.4). The level of RA disease activity can be interpreted as low (DAS28 <=3.2),moderate (3.2 < DAS28 <=5.1), or as high disease activity (DAS28 > 5.1)
Time Frame
At baseline, Day 85 and Day 169
Title
Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169
Description
Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.
Time Frame
At baseline, Day 85 and Day 169
Title
Cumulative Corticosteroid and Immunosuppressant Use
Description
Percent of participants requiring use of corticosteroids and mmunosuppressants use over time
Time Frame
Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlier
Title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
Description
Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions
Time Frame
On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlier
Title
Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate
Description
HEART RATE (HR) Beats per min (BPM): HR > 100 AND CHANGE FROM BASELINE > 30 OR HR < 55 AND CHANGE FROM BASELINE < -15
Time Frame
At Day 85 and Day 169
Title
Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
Description
SYSTOLIC BLOOD PRESSURE (SYSBP) (MMHG); SYSBP > 140 AND CHANGE FROM BASELINE > 20 OR SYSBP < 90 AND CHANGE FROM BASELINE < -20; DIASTOLIC BLOOD PRESSURE (DIABP) > 90 AND CHANGE FROM BASELINE > 10 OR DIABP < 55 AND CHANGE FROM BASELINE < -10;
Time Frame
At Day 85 and Day 169
Title
Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate
Description
RESPIRATION RATE (RESP) (PER MIN) RESP > 16 OR RESP CHANGE FROM BASELINE > 10
Time Frame
At Day 85 and Day 169
Title
Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature
Description
TEMPERATURE (TEMP) (C) TEMP > 38.3 OR TEMP CHANGE FROM BASELINE > 1.6
Time Frame
At Day 85 and Day 169
Title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description
QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF
Time Frame
Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier.
Title
Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified
Description
Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Ctrough = Trough level serum concentration of BMS-931699 at time point specified Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data.
Time Frame
Day 169
Title
Serum Biomarkers C3, C4
Description
Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169
Time Frame
At Day 85 and Day 169
Title
Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
Description
Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169. No anti-dsDNA data was available for this report
Time Frame
At Day 85 and Day 169
Title
Short Term: Receptor Occupancy Over Time
Description
Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy
Time Frame
At Day 85 and Day 169
Title
Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified
Description
Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period.
Time Frame
Day 169
Title
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
Description
HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN G/L L < 0.85×PRE-RX; HEMATOCRIT VOL L < 0.85×PRE-RX; PLATELET COUNT X10*9 C/L H > 1.5×ULN (ULN = Upper Limit of Normal) IF PRE-RX IS MISSING OR > 1.5×ULN PLATELET COUNT X10*9 C/L L < 0.85×LLN (LLN = Lower Limit of Normal) IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >= LLN OR < 0.85×PRE-RX IF PRE-RX < LLN; ERYTHROCYTES RBC X10*12 C/L L < 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES X10*9 C/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF LLN <= PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; LEUKOCYTES WBC X10*9 C/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF LLN <= PRE-RX <= ULN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
Description
WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) X10*9 C/L H > 0.4; BLASTS (ABSOLUTE) X10*9 C/L H > 0; EOSINOPHILS (ABSOLUTE) EOSA X10*9 C/L H > 0.75; LYMPHOCYTES (ABSOLUTE) X10*9 C/L H > 7.5; LYMPHOCYTES (ABSOLUTE) X10*9 C/L L < 0.75; MONOCYTES (ABSOLUTE) X10*9 C/L H > 2; NEUTROPHILS (ABSOLUTE) X10*9 C/L L < 1.5 IF PRE-RX IS MISSING OR < 1.5 IF PRE-RX >= 1.5 OR < 0.85×PRE-RX IF PRE-RX < 1.5; COAGULATION activated Partial thromboplastin time (APTT) SEC H > 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H > 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H > 1.5×ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
Description
LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H > 1.15×ULN IF PRE-RX IS MISSING OR > 1.15×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN BILIRUBIN, TOTAL UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
Description
KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN CREATININE UMOL/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.33×PRE-RX IF PRE-RX > ULN GLOMERULAR FILTRATION RATE, CALC. ML/S/M*2 L < 0.8×PRE-RX; UREA UREA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1
Description
CALCIUM, TOTAL MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CALCIUM, TOTAL MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; CHLORIDE, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CHLORIDE, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN;
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
Description
BICARBONATE MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; BICARBONATE MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; POTASSIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; POTASSIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; MAGNESIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN MAGNESIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3
Description
SODIUM, SERUM MMOL/L H > 1.05×ULN IF PRE-RX IS MISSING OR > 1.05×ULN IF PRE-RX <= ULN OR > 1.05×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN SODIUM, SERUM MMOL/L L < 0.95×LLN IF PRE-RX IS MISSING OR < 0.95×LLN IF PRE-RX >= LLN OR < 0.95×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >=LLN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
Description
GLUCOSE TESTS:GLUCOSE, FASTING SERUM MMOL/L H > 1.3×ULN IF PRE-RX IS MISSING OR > 1.3×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN GLUCOSE, FASTING SERUM MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; PROTEIN TESTS:ALBUMIN G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN PROTEIN, TOTAL G/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PROTEIN, TOTAL G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
Description
OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN TRIGLYCERIDES, FASTING MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN PANCREATIC TESTS: AMYLASE, TOTAL U/L H > 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) U/L H > 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) U/L H > 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM NMOL/L L < 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
Description
OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN; TROPONIN-I, CARDIAC SPECIFIC UG/L H > ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY
Description
IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H > 1.5×ULN; CRP, HIGH SENSITIVITY MG/L H > 1.5×ULN;
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
Description
QUALITATIVE URINE CHEMISTRY: BLOOD, URINE N/A H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 GLUCOSE, URINE N/A H >= 1 IF PRE-RX IS MISSING OR >= 1 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 PROTEIN, URINE UNKNOWN H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2 WBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2
Time Frame
Up to 42 days post last dose of study medication in short-term or long-term extension period
Title
Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169
Description
Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The SLEDAI-2K score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
Time Frame
At baseline, Day 85 and Day 169
Title
Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169
Description
Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very good and 100 mm = very bad.
Time Frame
At baseline, Day 85 and Day 169

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Male or female aged between 18 to 70 (included) Diagnosed with active systemic lupus erythematosus by a doctor Disease must be in patient's joints or on the skin at a minimum Taking other medications is allowed but some are excluded Exclusion Criteria: Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Associates Of North Alabama, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
St Jude Hospital Yorba Linda
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
University Of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Local Institution
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Center For Rheumatology, Immunology And Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
The Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684-3176
Country
United States
Facility Name
Jefrey D. Lieberman, Md., Pc
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Coeur D'Alene Arthrit Clin
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814-2644
Country
United States
Facility Name
Heartland Research Associates, Llc
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207-5150
Country
United States
Facility Name
Beth Israel Deaconess Med. Center Div. Of Gastroenterology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Physician Research Collaboration, Llc
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-2631
Country
United States
Facility Name
North Shore Lij Health System
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
The Feinstein Institute For Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Joint and Muscle Medical Care and Research Institute (JMMCRI)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Pmg Research Of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
East Penn Rheumatology Associates, P.C.
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Allegheny-Singer Research Institute (Asri)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Tekton Research Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Arthritis Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Hospital General De Agudos J.M. Ramos Mejia
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Instituto De Investigaciones Clinicas De Mar Del Plata
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Instituto de Asistencia Reumatologica Integral
City
San Fernando
State/Province
Buenos Aires
ZIP/Postal Code
1646
Country
Argentina
Facility Name
Clinica De Reumatologia
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro Consultora Integral de Salud SRL
City
Cordoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
Servicos Especializados em Reumatologia SER
City
Savaldor
State/Province
Bahia
ZIP/Postal Code
40150-150
Country
Brazil
Facility Name
Cip Pesquisas Medicas
City
Goiania
State/Province
Goias
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Centro Mineiro De Pesquisa
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010570
Country
Brazil
Facility Name
Centro Medico Varginha
City
Varginha
State/Province
Minas Gerais
ZIP/Postal Code
37006-710
Country
Brazil
Facility Name
Edumed - Educacao em Saude S/S LTDA
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80440-210
Country
Brazil
Facility Name
LMK Servicos Medicos S S Ltda
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
CPCLIN Centro de Pesquisas Clinicas LTDA
City
Sao Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Lar Escola AACD
City
Sao Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
Karma Clinical Trials Inc.
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Toronto Western Hospital, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Centre De Recherche Musculo-Squelettique
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
CHU de Quebec Research Centre
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Centro De Estudios Reumatologicos
City
Santiago De Chile
State/Province
Metropolitana
ZIP/Postal Code
7501126
Country
Chile
Facility Name
Hospital San Borja Arriaran
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
8360156
Country
Chile
Facility Name
Riesgo De Fractura
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Servimed E.U
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Clinica De La Costa
City
Barranquilla
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
ZIP/Postal Code
MEDELLIN
Country
Colombia
Facility Name
Local Institution
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Local Institution
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Campus Charite Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Medizinsche Universitaetsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetshautklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Johannes Gutenberg - Universitaet
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Infektologiai-Hepatologiai Osztaly
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Borgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Arcispedale S. Anna
City
Cona - Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Azienda Ospedaliera Luigi Sacco
City
Milano
ZIP/Postal Code
20154
Country
Italy
Facility Name
Azienda Ospedaliera Di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Policlinico Umberto I
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Local Institution
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
2608677
Country
Japan
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Local Institution
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
8078555
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608604
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Local Institution
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Local Institution
City
Sasebo-shi
State/Province
Nagasaki
ZIP/Postal Code
8571195
Country
Japan
Facility Name
Local Institution
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
3290498
Country
Japan
Facility Name
Local Institution
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138655
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1048560
Country
Japan
Facility Name
Local Institution
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
1838524
Country
Japan
Facility Name
Local Institution
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
1738610
Country
Japan
Facility Name
Local Institution
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
1538515
Country
Japan
Facility Name
Local Institution
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Local Institution
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Name
Local Institution
City
Beirut
Country
Lebanon
Facility Name
Local Institution
City
Tripoli
Country
Lebanon
Facility Name
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
City
Mexico City
State/Province
Distrito Fededral
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Instituto para el DeSarrollo Integral de la Salud S de RL de CV
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Centro Integral En Reumatologia Sa De Cv
City
Guadalajara, Jalisco
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.
City
Villahermosa
State/Province
Tabasco
ZIP/Postal Code
86190
Country
Mexico
Facility Name
Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.
City
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Unidad Reumatologica Las Americas, S.C. P.
City
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Local Institution
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Clinica Anglo Americana
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
City
Lima
ZIP/Postal Code
LIMA 33
Country
Peru
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
00-465
Country
Poland
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Sf. Maria Clinical Hospital,Bucharest
City
Bucharest
ZIP/Postal Code
011192
Country
Romania
Facility Name
Spitalul Clinic de Recuperare Iasi
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
Local Institution
City
St Petersburg
ZIP/Postal Code
191124
Country
Russian Federation
Facility Name
Local Institution
City
Tolyatti
ZIP/Postal Code
445039
Country
Russian Federation
Facility Name
Local Institution
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution
City
Stellenbosch
State/Province
Western CAPE
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Hosp Univer 12 De Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Carlos Haya De Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Meixoeiro
City
Vigo
ZIP/Postal Code
36241
Country
Spain
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

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Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

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