A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
NCT ID: NCT01196091
Last Updated: 2018-06-12
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1164 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-12-31
Study Completion Date
2015-06-30
Brief Summary
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The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.
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Detailed Description
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Conditions
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Systemic Lupus Erythematosus
Connective Tissue Disease
Autoimmune Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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LY2127399 every 2 weeks
Administered SC
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
DRUG
120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Standard of Care
Intervention Type
DRUG
LY2127399 every 4 wks
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
DRUG
120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Placebo every 4 weeks
Intervention Type
DRUG
Administered via subcutaneous injection for 52 weeks.
Standard of Care
Intervention Type
DRUG
Placebo
Administered SC
Group Type
PLACEBO_COMPARATOR
Placebo every 2 weeks
Intervention Type
DRUG
Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose
Standard of Care
Intervention Type
DRUG
Interventions
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LY2127399
120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Intervention Type
DRUG
Placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose
Intervention Type
DRUG
Placebo every 4 weeks
Administered via subcutaneous injection for 52 weeks.
Intervention Type
DRUG
Standard of Care
Intervention Type
DRUG
Other Intervention Names
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Non-steroidal anti-inflammatory drug
Corticosteroids
Antimalarials (used for SLE)
Immunosuppressants
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of SLE 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.)
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Paradise Valley, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Glendale, California, United States
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Lakewood, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Sacramento, California, United States
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San Leandro, California, United States
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Upland, California, United States
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Danbury, Connecticut, United States
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Farmington, Connecticut, United States
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Norwich, Connecticut, United States
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Trumbull, Connecticut, United States
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Boca Raton, Florida, United States
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Clearwater, Florida, United States
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Doral, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Lake Mary, Florida, United States
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Miami, Florida, United States
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Orange Park, Florida, United States
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Palm Harbor, Florida, United States
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St. Petersburg, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Muncie, Indiana, United States
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Kansas City, Kansas, United States
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Bowling Green, Kentucky, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Hagerstown, Maryland, United States
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Wheaton, Maryland, United States
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Grand Rapids, Michigan, United States
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Eagan, Minnesota, United States
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Florissant, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Clifton, New Jersey, United States
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Teaneck, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Endwell, New York, United States
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Manhasset, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Hickory, North Carolina, United States
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Cincinnati, Ohio, United States
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Middleburg Heights, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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North Charleston, South Carolina, United States
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Crossville, Tennessee, United States
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Hixon, Tennessee, United States
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Jackson, Tennessee, United States
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Allen, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Waco, Texas, United States
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Chesapeake, Virginia, United States
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Danville, Virginia, United States
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Richmond, Virginia, United States
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Williamsburg, Virginia, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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Caba, , Argentina
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Córdoba, , Argentina
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Rosario, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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Graz, , Austria
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Vienna, , Austria
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Brest, , Belarus
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Grodno, , Belarus
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Minsk, , Belarus
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Kelowna, British Columbia, Canada
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Markham, Ontario, Canada
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Newmarket, Ontario, Canada
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Osorno, , Chile
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Santiago, , Chile
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Valdivia, , Chile
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Cali, , Colombia
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Chía, , Colombia
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Medellín, , Colombia
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Osijek, , Croatia
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Al Minyā, , Egypt
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Alexandria, , Egypt
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Cairo, , Egypt
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Bad Nauheim, , Germany
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Baden-Baden, , Germany
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Berlin, , Germany
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Erlangen, , Germany
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Freiburg im Breisgau, , Germany
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Hildesheim, , Germany
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Jena, , Germany
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Zerbst, , Germany
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Guatemala City, , Guatemala
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Brescia, , Italy
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Genova, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Palermo, , Italy
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Scafati, , Italy
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Torino, , Italy
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Aichi, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Hokkaido, , Japan
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Japan, , Japan
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Miyagi, , Japan
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Nagasaki, , Japan
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Osaka, , Japan
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Tokyo, , Japan
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Bitola, , North Macedonia
Site Status
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Shtip, , North Macedonia
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Skopje, , North Macedonia
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Arequipa, , Peru
Site Status
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Lima, , Peru
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Lince, , Peru
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Piura, , Peru
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Angeles City, , Philippines
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Cebu, , Philippines
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Davao City, , Philippines
Site Status
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Ermita, , Philippines
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España, , Philippines
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Iloilo City, , Philippines
Site Status
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Manila, , Philippines
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Paranaque City, , Philippines
Site Status
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Quezon City, , Philippines
Site Status
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?Ód?, , Poland
Site Status
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Bytom, , Poland
Site Status
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Poznan, , Poland
Site Status
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Sosnowiec, , Poland
Site Status
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Warsaw, , Poland
Site Status
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Wroc?Aw, , Poland
Site Status
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San Juan, , Puerto Rico
Site Status
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Santurce, , Puerto Rico
Site Status
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Singapore, , Singapore
Site Status
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Bucheon-si, , South Korea
Site Status
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Daegu, , South Korea
Site Status
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Daejeon, , South Korea
Site Status
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Gwangju, , South Korea
Site Status
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Incheon, , South Korea
Site Status
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Jeonju, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Suwon, , South Korea
Site Status
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Bangkok, , Thailand
Site Status
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Chiang Mai, , Thailand
Site Status
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Donetsk, , Ukraine
Site Status
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Ivano-Frankivsk, , Ukraine
Site Status
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Kharkiv, , Ukraine
Site Status
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Kryvyi Rih, , Ukraine
Site Status
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Kyiv, , Ukraine
Site Status
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Lviv, , Ukraine
Site Status
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Odesa, , Ukraine
Site Status
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Simferopol, , Ukraine
Site Status
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Ternopil, , Ukraine
Site Status
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Uzhhorod, , Ukraine
Site Status
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Vinnytsia, , Ukraine
Site Status
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Zaporizhzhia, , Ukraine
Site Status
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Zhytomyr, , Ukraine
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Argentina
Austria
Belarus
Bulgaria
Canada
Chile
Colombia
Croatia
Egypt
Germany
Guatemala
Italy
Japan
North Macedonia
Peru
Philippines
Poland
Puerto Rico
Singapore
South Korea
Thailand
Ukraine
References
Explore related publications, articles, or registry entries linked to this study.
Vendel AC, Jaroszewski L, Linnik MD, Godzik A. B- and T-Lymphocyte Attenuator in Systemic Lupus Erythematosus Disease Pathogenesis. Clin Pharmacol Ther. 2024 Jul;116(1):247-256. doi: 10.1002/cpt.3282. Epub 2024 Apr 26.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Isenberg DA, Petri M, Kalunian K, Tanaka Y, Urowitz MB, Hoffman RW, Morgan-Cox M, Iikuni N, Silk M, Wallace DJ. Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2016 Feb;75(2):323-31. doi: 10.1136/annrheumdis-2015-207653. Epub 2015 Sep 3.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H9B-MC -BCDS
Identifier Type: OTHER
Identifier Source: secondary_id
13656
Identifier Type: -
Identifier Source: org_study_id
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