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

Lupus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265744
• Other study ID #: IM128-027
• Secondary ID: 2014-002184-14
• Status: Completed
• Phase: Phase 2
• Start date: November 13, 2014
• Est. completion date: November 30, 2017

Study information

• Verified date: October 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period

2. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: November 30, 2017
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus
• Lupus Erythematosus, Systemic

Intervention

Drug:
• BMS-931699

• Placebo matching BMS-931699

Locations

Country	Name	City	State
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Hospital General De Agudos J.M. Ramos Mejia	Ciudad Autonoma De Buenos Aire	Buenos Aires
Argentina	Centro Consultora Integral de Salud SRL	Cordoba
Argentina	Instituto De Investigaciones Clinicas De Mar Del Plata	Mar Del Plata	Buenos Aires
Argentina	Clinica De Reumatologia	Rosario	Santa FE
Argentina	Instituto de Asistencia Reumatologica Integral	San Fernando	Buenos Aires
Brazil	Edumed - Educacao em Saude S/S LTDA	Curitiba	Parana
Brazil	Cip Pesquisas Medicas	Goiania	Goias
Brazil	Centro Mineiro De Pesquisa	Juiz de Fora	Minas Gerais
Brazil	LMK Servicos Medicos S S Ltda	Porto Alegre	RIO Grande DO SUL
Brazil	CPCLIN Centro de Pesquisas Clinicas LTDA	Sao Paulo
Brazil	Lar Escola AACD	Sao Paulo
Brazil	Servicos Especializados em Reumatologia SER	Savaldor	Bahia
Brazil	Centro Medico Varginha	Varginha	Minas Gerais
Canada	McMaster University	Hamilton	Ontario
Canada	CHU de Quebec Research Centre	Quebec
Canada	Karma Clinical Trials Inc.	St. John's	Newfoundland and Labrador
Canada	Toronto Western Hospital, University Health Network	Toronto	Ontario
Canada	Centre De Recherche Musculo-Squelettique	Trois-rivieres	Quebec
Chile	Hospital San Borja Arriaran	Santiago	Region Metropolitana
Chile	Centro De Estudios Reumatologicos	Santiago De Chile	Metropolitana
Colombia	Clinica De La Costa	Barranquilla
Colombia	Riesgo De Fractura	Bogota	Cundinamarca
Colombia	Servimed E.U	Bucaramanga	Santander
Colombia	Hospital Pablo Tobon Uribe	Medellin
France	Local Institution	Bordeaux Cedex
France	Local Institution	Lille Cedex
France	Local Institution	Marseille
France	Local Institution	Paris Cedex 13
France	Local Institution	Strasbourg
Germany	Campus Charite Mitte	Berlin
Germany	Medizinsche Universitaetsklinik Freiburg	Freiburg
Germany	Universitaetshautklinik Heidelberg	Heidelberg
Germany	Johannes Gutenberg - Universitaet	Mainz
Hungary	Budai Irgalmasrendi Korhaz	Budapest
Hungary	Infektologiai-Hepatologiai Osztaly	Gyula
Hungary	Borgyogyaszati Klinika	Szeged
Italy	Arcispedale S. Anna	Cona - Ferrara
Italy	Azienda Ospedaliera Luigi Sacco	Milano
Italy	Azienda Ospedaliera Di Padova	Padova
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Policlinico Umberto I	Roma
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Chiba-shi	Chiba
Japan	Local Institution	Chuo-ku	Tokyo
Japan	Local Institution	Fuchu	Tokyo
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Itabashi-ku	Tokyo
Japan	Local Institution	Kanazawa-shi	Ishikawa
Japan	Local Institution	Kitakyushu-shi	Fukuoka
Japan	Local Institution	Meguro-ku	Tokyo
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sasebo-shi	Nagasaki
Japan	Local Institution	Sendai	Miyagi
Japan	Local Institution	Shimotsuke-shi	Tochigi
Japan	Local Institution	Shinjuku-Ku	Tokyo
Korea, Republic of	Local Institution	Daejeon
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Lebanon	Local Institution	Beirut
Lebanon	Local Institution	Tripoli
Mexico	Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.	Distrito Federal
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S.C.	Guadalajara	Jalisco
Mexico	Centro Integral En Reumatologia Sa De Cv	Guadalajara, Jalisco	Jalisco
Mexico	Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia	León	Guanajuato
Mexico	Instituto para el DeSarrollo Integral de la Salud S de RL de CV	Mexico	Distrito Federal
Mexico	CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.	Mexico City	Distrito Fededral
Mexico	Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.	San Luis Potosi
Mexico	Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.	Villahermosa	Tabasco
Mexico	Unidad Reumatologica Las Americas, S.C. P.	Yucatan
Netherlands	Local Institution	Den Haag
Netherlands	Local Institution	Groningen
Peru	Clinica Anglo Americana	Lima
Peru	Hospital Nacional Cayetano Heredia	Lima
Peru	Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac	Lima
Poland	Local Institution	Lublin
Poland	Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar	Poznan
Poland	Local Institution	Warszawa
Puerto Rico	Local Institution	San Juan
Romania	Sf. Maria Clinical Hospital,Bucharest	Bucharest
Romania	Spitalul Clinic de Recuperare Iasi	Iasi
Russian Federation	Local Institution	St Petersburg
Russian Federation	Local Institution	Tolyatti
South Africa	Local Institution	Cape Town	Western CAPE
South Africa	Local Institution	Johannesburg	Gauteng
South Africa	Local Institution	Soweto	Gauteng
South Africa	Local Institution	Stellenbosch	Western CAPE
Spain	Hosp Univer 12 De Octubre	Madrid
Spain	Hospital Carlos Haya De Malaga	Malaga
Spain	Hospital Meixoeiro	Vigo
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taoyuan
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Tekton Research Inc	Austin	Texas
United States	East Penn Rheumatology Associates, P.C.	Bethlehem	Pennsylvania
United States	Beth Israel Deaconess Med. Center Div. Of Gastroenterology	Boston	Massachusetts
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Joint and Muscle Medical Care and Research Institute (JMMCRI)	Charlotte	North Carolina
United States	Coeur D'Alene Arthrit Clin	Coeur d'Alene	Idaho
United States	Local Institution	Dallas	Texas
United States	Jefrey D. Lieberman, Md., Pc	Decatur	Georgia
United States	University Of Connecticut Health Center	Farmington	Connecticut
United States	Center For Rheumatology, Immunology And Arthritis	Fort Lauderdale	Florida
United States	St Jude Hospital Yorba Linda	Fullerton	California
United States	North Shore Lij Health System	Great Neck	New York
United States	Rheumatology Associates Of North Alabama, P.C.	Huntsville	Alabama
United States	Physician Research Collaboration, Llc	Lincoln	Nebraska
United States	Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.	Long Beach	California
United States	The Feinstein Institute For Medical Research	Manhasset	New York
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	The Arthritis Center	Palm Harbor	Florida
United States	Allegheny-Singer Research Institute (Asri)	Pittsburgh	Pennsylvania
United States	Pmg Research Of Salisbury	Salisbury	North Carolina
United States	Arthritis Northwest	Spokane	Washington
United States	Harbor UCLA Medical Center	Torrance	California
United States	Local Institution	Trumbull	Connecticut
United States	Heartland Research Associates, Llc	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Chile,  Colombia,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Mexico,  Netherlands,  Peru,  Poland,  Puerto Rico,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Day 169
Secondary	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)	At Day 169
Secondary	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)	At Day 85
Secondary	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.	At Day 85
Secondary	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.	At Day 85 and Day 169
Secondary	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.	At Day 85 and Day 169
Secondary	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)	At baseline, Day 85 and Day 169
Secondary	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.	At baseline, Day 85 and Day 169
Secondary	Cumulative Corticosteroid and Immunosuppressant Use	Percent of participants requiring use of corticosteroids and mmunosuppressants use over time	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
Secondary	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	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
Secondary	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	At Day 85 and Day 169
Secondary	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;	At Day 85 and Day 169
Secondary	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	At Day 85 and Day 169
Secondary	Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature	TEMPERATURE (TEMP) (C) TEMP > 38.3 OR TEMP CHANGE FROM BASELINE > 1.6	At Day 85 and Day 169
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF	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.
Secondary	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.	Day 169
Secondary	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	At Day 85 and Day 169
Secondary	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	At Day 85 and Day 169
Secondary	Short Term: Receptor Occupancy Over Time	Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy	At Day 85 and Day 169
Secondary	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.	Day 169
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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;	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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;	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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	Up to 42 days post last dose of study medication in short-term or long-term extension period
Secondary	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.	At baseline, Day 85 and Day 169
Secondary	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.	At baseline, Day 85 and Day 169

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