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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LY2127399

Placebo every 2 weeks

Placebo every 4 weeks

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Systemic Lupus Erythematosis, Lupus, autoimmune disease, LY2127399, Immune System Disease

Eligibility Criteria

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

Inclusion Criteria:

Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria
Have positive antinuclear antibodies (ANA)
Agree not to become pregnant throughout the course of the trial
Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)

Exclusion Criteria:

Have active severe Lupus kidney disease
Have active Central Nervous System or peripheral neurologic disease
Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
Have active or recent infection within 30 days of screening
Have had a serious infection within 90 days of randomization
Have evidence or test positive for Hepatitis B
Have Hepatitis C
Are human immunodeficiency virus (HIV) positive
Have evidence of active or latent tuberculosis (TB)
Presence of significant laboratory abnormalities at screening
Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
Have changed your dose of antimalarial drug in the past 30 days
Have changed your dose of immunosuppressive drug in the past 90 days
Have previously received rituximab

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

LY2127399 every 2 weeks

LY2127399 every 4 weeks

Placebo

Arm Description

During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an SLE Responder Index Response at Week 52

Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.

Secondary Outcome Measures

Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52

A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit.

Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level

Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.

Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score

SLE Disease Activity Index 2000 (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 to First Severe SLE Flare (SFI)

The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity. Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1).

Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)

PGA is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening defined as increase of ≤ 0.30 points from Baseline.

Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores

The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.

Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks

Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the participant's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100.No worsening defined as increase of ≤ 0.30 points from Baseline.

Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores

A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).

Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares

The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare. Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit.

Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks

An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.

Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score

Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.

Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline

Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks

Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score) SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.

Full Information

NCT ID

NCT01205438

First Posted

September 17, 2010

Last Updated

June 18, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01205438

Brief Title

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.

6. Conditions and Keywords

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

Systemic Lupus Erythematosus, Connective Tissue Disease, Autoimmune Disease

Keywords

SLE, Systemic Lupus Erythematosis, Lupus, autoimmune disease, LY2127399, Immune System Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY2127399 every 2 weeks

Arm Type

Experimental

Arm Title

LY2127399 every 4 weeks

Arm Type

Experimental

Arm Description

During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LY2127399

Intervention Description

120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug

Intervention Type

Drug

Intervention Name(s)

Placebo every 2 weeks

Intervention Description

Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.

Intervention Type

Drug

Intervention Name(s)

Placebo every 4 weeks

Intervention Description

Administered via subcutaneous injection for 52 weeks.

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving an SLE Responder Index Response at Week 52

Description

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52

Description

Time Frame

52 weeks

Title

Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level

Description

Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.

Time Frame

Baseline, 52 weeks

Title

Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score

Description

Time Frame

Baseline, 52 weeks

Title

Time to First Severe SLE Flare (SFI)

Description

Time Frame

Baseline through 52 weeks

Title

Change From Baseline to 52 Week Endpoint in Physician's Global Assessment (PGA)

Description

Time Frame

Baseline, 52 weeks

Title

Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQOL) Domain Scores

Description

Time Frame

Baseline, 52 weeks

Title

Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks

Description

Time Frame

52 weeks

Title

Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores

Description

Time Frame

Baseline, 52 weeks

Title

Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares

Description

Time Frame

Baseline through 52 weeks

Title

Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks

Description

Time Frame

52 weeks

Title

Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score

Description

Time Frame

Baseline, 52 weeks

Title

Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline

Description

Time Frame

Baseline through 52 weeks

Title

Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks

Description

Time Frame

52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria Have positive antinuclear antibodies (ANA) Agree not to become pregnant throughout the course of the trial Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.) Exclusion Criteria: Have active severe Lupus kidney disease Have active Central Nervous System or peripheral neurologic disease Have received intravenous immunoglobulin (IVIg) within 180 days of randomization Have active or recent infection within 30 days of screening Have had a serious infection within 90 days of randomization Have evidence or test positive for Hepatitis B Have Hepatitis C Are human immunodeficiency virus (HIV) positive Have evidence of active or latent tuberculosis (TB) Presence of significant laboratory abnormalities at screening Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization Have received greater than 40 mgs of prednisone or equivalent in the past 30 days Have changed your dose of antimalarial drug in the past 30 days Have changed your dose of immunosuppressive drug in the past 90 days Have previously received rituximab

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT -5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

City

Malvern

State/Province

Arkansas

ZIP/Postal Code

72104

Country

United States

Facility Name

City

Covina

State/Province

California

ZIP/Postal Code

91723

Country

United States

Facility Name

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

Facility Name

City

Escondido

State/Province

California

ZIP/Postal Code

92027

Country

United States

Facility Name

City

La Mesa

State/Province

California

ZIP/Postal Code

91941

Country

United States

Facility Name

City

Lakewood

State/Province

California

ZIP/Postal Code

90712

Country

United States

Facility Name

City

Los Alamitos

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

City

Pasadena

State/Province

California

ZIP/Postal Code

91107

Country

United States

Facility Name

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

City

San Gabriel

State/Province

California

ZIP/Postal Code

91776

Country

United States

Facility Name

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93108

Country

United States

Facility Name

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

City

Whittier

State/Province

California

ZIP/Postal Code

90606

Country

United States

Facility Name

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20060

Country

United States

Facility Name

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32514

Country

United States

Facility Name

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

City

Duluth

State/Province

Georgia

ZIP/Postal Code

30096

Country

United States

Facility Name

City

Lithonia

State/Province

Georgia

ZIP/Postal Code

30038

Country

United States

Facility Name

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61107

Country

United States

Facility Name

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46804

Country

United States

Facility Name

City

Granger

State/Province

Indiana

ZIP/Postal Code

46530

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Facility Name

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

City

Saint Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39402

Country

United States

Facility Name

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

City

Nashua

State/Province

New Hampshire

ZIP/Postal Code

03060

Country

United States

Facility Name

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

City

Las Cruces

State/Province

New Mexico

ZIP/Postal Code

88011

Country

United States

Facility Name

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

City

Roslyn

State/Province

New York

ZIP/Postal Code

11576

Country

United States

Facility Name

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27617

Country

United States

Facility Name

City

Rocky Mount

State/Province

North Carolina

ZIP/Postal Code

27804

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Facility Name

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

City

Cookeville

State/Province

Tennessee

ZIP/Postal Code

38501

Country

United States

Facility Name

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38163

Country

United States

Facility Name

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78665

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78232

Country

United States

Facility Name

City

Victoria

State/Province

Texas

ZIP/Postal Code

77901

Country

United States

Facility Name

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

City

Cairns

State/Province

Queensland

ZIP/Postal Code

4870

Country

Australia

Facility Name

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

City

Malvern East

ZIP/Postal Code

3145

Country

Australia

Facility Name

City

Campinas

ZIP/Postal Code

13015-011

Country

Brazil

Facility Name

City

Goiania

ZIP/Postal Code

74110-120

Country

Brazil

Facility Name

City

Juiz De Fora

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

City

Salvador

ZIP/Postal Code

40050-410

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

04039-901

Country

Brazil

Facility Name

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

Facility Name

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

City

Cuenca

ZIP/Postal Code

EC010150

Country

Ecuador

Facility Name

City

Guayaquil

ZIP/Postal Code

90110321

Country

Ecuador

Facility Name

City

Quito

ZIP/Postal Code

Country

Ecuador

Facility Name

City

Orleans

ZIP/Postal Code

45000

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

City

Bangalore

ZIP/Postal Code

560043

Country

India

Facility Name

City

Gujarat

ZIP/Postal Code

380015

Country

India

Facility Name

City

Haryana

ZIP/Postal Code

122001

Country

India

Facility Name

City

Hyderabaad

ZIP/Postal Code

500082

Country

India

Facility Name

City

Kormangala

ZIP/Postal Code

560034

Country

India

Facility Name

City

Pune

ZIP/Postal Code

411007

Country

India

Facility Name

City

Trivandrum

ZIP/Postal Code

695011

Country

India

Facility Name

City

Haifa

ZIP/Postal Code

34362

Country

Israel

Facility Name

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

52651

Country

Israel

Facility Name

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

City

Kota Kinabalu

ZIP/Postal Code

88586

Country

Malaysia

Facility Name

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

City

Guadalajara

ZIP/Postal Code

44650

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97130

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

06090

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78200

Country

Mexico

Facility Name

City

San Luis

ZIP/Postal Code

78240

Country

Mexico

Facility Name

City

Tijuana

ZIP/Postal Code

22010

Country

Mexico

Facility Name

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

City

Otahuhu

ZIP/Postal Code

1640

Country

New Zealand

Facility Name

City

Takapuna

ZIP/Postal Code

622

Country

New Zealand

Facility Name

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

City

Bucharest

ZIP/Postal Code

020475

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

City

Galati

ZIP/Postal Code

800587

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700656

Country

Romania

Facility Name

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

City

Chelyabinsk

ZIP/Postal Code

454076

Country

Russian Federation

Facility Name

City

Ekaterinburg

ZIP/Postal Code

620012

Country

Russian Federation

Facility Name

City

Kazan

ZIP/Postal Code

420097

Country

Russian Federation

Facility Name

City

Kemerovo

ZIP/Postal Code

650099

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

125101

Country

Russian Federation

Facility Name

City

Orenburg

ZIP/Postal Code

460018

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

197089

Country

Russian Federation

Facility Name

City

Tomsk

ZIP/Postal Code

634063

Country

Russian Federation

Facility Name

City

Yaroslavl

ZIP/Postal Code

150023

Country

Russian Federation

Facility Name

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

City

Niska Banja

ZIP/Postal Code

18205

Country

Serbia

Facility Name

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

City

Stellenbosch

ZIP/Postal Code

7600

Country

South Africa

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

City

Las Palmas De Gran Canaria

ZIP/Postal Code

35010

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

City

Vigo

ZIP/Postal Code

36200

Country

Spain

Facility Name

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

City

Hualien

ZIP/Postal Code

970

Country

Taiwan

Facility Name

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

City

Taichung City

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

10630

Country

Taiwan

Facility Name

City

La Marsa

ZIP/Postal Code

2070

Country

Tunisia

Facility Name

City

Monastir

ZIP/Postal Code

5000

Country

Tunisia

Facility Name

City

Sfax

ZIP/Postal Code

3029

Country

Tunisia

Facility Name

City

Sousse

ZIP/Postal Code

4000

Country

Tunisia

Facility Name

City

Tunis Monfleury

ZIP/Postal Code

1008

Country

Tunisia

Facility Name

City

Tunis

ZIP/Postal Code

1008

Country

Tunisia

Facility Name

City

Cambridge

State/Province

Cambridgeshire

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

City

Poole

State/Province

Dorset

ZIP/Postal Code

BH15 2JB

Country

United Kingdom

Facility Name

City

London

State/Province

Greater London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

City

Maidstone

State/Province

Kent

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

Facility Name

City

Wigan

State/Province

Lancashire

ZIP/Postal Code

WN6 0LW

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35947992

Citation

Toro-Dominguez D, Martorell-Marugan J, Martinez-Bueno M, Lopez-Dominguez R, Carnero-Montoro E, Barturen G, Goldman D, Petri M, Carmona-Saez P, Alarcon-Riquelme ME. Scoring personalized molecular portraits identify Systemic Lupus Erythematosus subtypes and predict individualized drug responses, symptomatology and disease progression. Brief Bioinform. 2022 Sep 20;23(5):bbac332. doi: 10.1093/bib/bbac332.

Results Reference

derived

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

PubMed Identifier

31790472

Citation

Li Y, Higgs RE, Hoffman RW, Dow ER, Liu X, Petri M, Wallace DJ, Dorner T, Eastwood BJ, Miller BB, Liu Y. A Bayesian gene network reveals insight into the JAK-STAT pathway in systemic lupus erythematosus. PLoS One. 2019 Dec 2;14(12):e0225651. doi: 10.1371/journal.pone.0225651. eCollection 2019.

Results Reference

derived

PubMed Identifier

29045736

Citation

Kalunian KC, Urowitz MB, Isenberg D, Merrill JT, Petri M, Furie RA, Morgan-Cox MA, Taha R, Watts S, Silk M, Linnik MD. Clinical trial parameters that influence outcomes in lupus trials that use the systemic lupus erythematosus responder index. Rheumatology (Oxford). 2018 Jan 1;57(1):125-133. doi: 10.1093/rheumatology/kex368.

Results Reference

derived

PubMed Identifier

27220348

Citation

Rovin BH, Dooley MA, Radhakrishnan J, Ginzler EM, Forrester TD, Anderson PW. The impact of tabalumab on the kidney in systemic lupus erythematosus: results from two phase 3 randomized, clinical trials. Lupus. 2016 Dec;25(14):1597-1601. doi: 10.1177/0961203316650734. Epub 2016 May 24.

Results Reference

derived

PubMed Identifier

27723281

Citation

Hoffman RW, Merrill JT, Alarcon-Riquelme MM, Petri M, Dow ER, Nantz E, Nisenbaum LK, Schroeder KM, Komocsar WJ, Perumal NB, Linnik MD, Airey DC, Liu Y, Rocha GV, Higgs RE. Gene Expression and Pharmacodynamic Changes in 1,760 Systemic Lupus Erythematosus Patients From Two Phase III Trials of BAFF Blockade With Tabalumab. Arthritis Rheumatol. 2017 Mar;69(3):643-654. doi: 10.1002/art.39950.

Results Reference

derived

PubMed Identifier

26293163

Citation

Merrill JT, van Vollenhoven RF, Buyon JP, Furie RA, Stohl W, Morgan-Cox M, Dickson C, Anderson PW, Lee C, Berclaz PY, Dorner T. Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B-cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):332-40. doi: 10.1136/annrheumdis-2015-207654. Epub 2015 Aug 20.

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A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

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