Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
NCT ID: NCT02794285
Last Updated: 2023-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
559 participants
INTERVENTIONAL
2016-06-30
2021-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anifrolumab
Anifrolumab
Anifrolumab
Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Placebo
Placebo
Placebo
Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Interventions
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Anifrolumab
Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Placebo
Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Eligibility Criteria
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Inclusion Criteria
2. Adequate peripheral venous access
3. Females with an intact cervix should have documentation of a Pap smear with no documented malignancy within 90 days before Day 1/Visit 1 or 30 days following Day 1/Visit 1. Since access to a Pap smear may vary by country, the Sponsor recommends that local guidelines for obtaining Pap smears in subjects who have received immunomodulators or immunosuppressive treatment be followed.
4. Meets the following TB criteria:
1. Negative QuantiFERON®-TB Gold \[QFT-G\] test result for TB obtained from the study central laboratory at Week 52 of Studies D3461C00004 or D3461C00005; OR
2. Newly positive QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory. A chest x-ray must be performed. If the chest x-ray shows no evidence of active TB, and the subject has no symptoms or medical history consistent with active TB, the subject must have a retest. If the retest is positive, the subject must start on prophylaxis within 30 days of randomisation but prior to the second dose of investigational product (Visit 2/Week 4); OR
3. Positive but not newly positive QFT-G test at Week 52 of Studies D3461C00004 or D3461C00005. The subject must have been diagnosed with latent TB and must have documentation confirming initiation of appropriate treatment OR initiate treatment for latent TB within 30 days of randomization, but prior to the second dose of investigational product administration (Visit 2/Week 4)
4. Newly indeterminate (confirmed on retest unless prior positive QFT G was documented, along with completed treatment for latent TB) or indeterminate but not newly indeterminate QFT-G test result at Week 52 of Studies D3461C00004 or D3461C00005 from the study central laboratory with ongoing QFT-G testing for TB according to the Study Plan
5. In the opinion of the Investigator, subject must be able to comprehend the ICF and all protocol related assessments
Exclusion Criteria
1. Azathioprine \>200 mg/day
2. Mycophenolate mofetil \>2.0 g/day /mycophenolic acid \>1.44 g/day
3. Oral, subcutaneous, or intramuscular methotrexate \>25 mg/week
4. Mizoribine \>150 mg/day
2. Receipt of any investigational product (small molecule or biologic agent other than anifrolumab) within 4 weeks or 5 half-lives prior to Day 1/Visit 1, whichever is greater
3. Receipt of any of the following:
1. Any live or attenuated vaccine within 8 weeks prior to Day 1/Visit 1 (administration of killed vaccines is acceptable, the Sponsor recommends Investigators ensure all subjects are up to date on required vaccinations, including influenza \[inactivated/recombinant\] vaccine prior to study entry)
2. Bacillus Calmette-Guerin (BCG) vaccine between the end of Studies D3461C00004 or D3461C00005 and Day 1/Visit 1
4. Active severe SLE-driven renal or neuropsychiatric disease
5. Any underlying condition that predisposes the subject to infection, including history of/current human immunodeficiency virus (HIV) infection
6. Subjects with Hepatitis B core antibody (HBcAb) positivity at enrolment of Studies D3461C00004 or D3461C00005 will be tested every 3 months for Hepatitis B virus (HBV) DNA. To remain eligible in the LTE study, subject HBV DNA levels must remain below the lower limit of quantitation as per the central laboratory.
7. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years of Day 1/Visit 1
18 Years
70 Years
ALL
No
Sponsors
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PRA Health Sciences
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Kalunian, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Raj Tummala, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
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El Cajon, California, United States
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Hemet, California, United States
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La Jolla, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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San Leandro, California, United States
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Thousand Oaks, California, United States
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Upland, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Bridgeport, Connecticut, United States
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Brandon, Florida, United States
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DeBary, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ormond Beach, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Marietta, Georgia, United States
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Boise, Idaho, United States
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Idaho Falls, Idaho, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Grand Rapids, Michigan, United States
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Minneapolis, Minnesota, United States
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Nashua, New Hampshire, United States
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Freehold, New Jersey, United States
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Las Cruces, New Mexico, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Greenville, North Carolina, United States
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Raleigh, North Carolina, United States
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Middleburg Heights, Ohio, United States
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Oklahoma City, 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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Reading, Pennsylvania, United States
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North Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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Stafford, Texas, United States
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Spokane, Washington, United States
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Milwaukee, Wisconsin, United States
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Mendoza, , Argentina
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Quilmes, , Argentina
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San Miguel de Tucumán, , Argentina
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Fitzroy, , Australia
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Kogarah, , Australia
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Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
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Hamilton, Ontario, Canada
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Rimouski, Quebec, Canada
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Osorno, , Chile
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Santiago, , Chile
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Viña del Mar, , Chile
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Armenia, , Colombia
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Barranquilla, , Colombia
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Medellín, , Colombia
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Bordeaux, , France
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Lille, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Berlin, , Germany
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Frankfurt am Main, , Germany
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Hamburg, , Germany
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Jena, , Germany
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Kirchheim, , Germany
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Mainz Am Rhein, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Zalaegerszeg, , Hungary
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Tel Aviv, , Israel
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Chiba, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Kitakyushu-shi, , Japan
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Kurashiki-shi, , Japan
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Meguro-ku, , Japan
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Meguro-ku, , Japan
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Nagasaki, , Japan
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Omura-shi, , Japan
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Sapporo, , Japan
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Sasebo-shi, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Chihuahua City, , Mexico
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León, , Mexico
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Mexico City, , Mexico
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Mérida, , Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Arequipa, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Kościan, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Nadarzyn, , Poland
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Starachowice, , Poland
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Szczecin, , Poland
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Ustroń, , Poland
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Warsaw, , Poland
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Brasov, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Galati, , Romania
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Târgu Mureş, , Romania
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Smolensk, , Russia
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Tolyatti, , Russia
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Vladimir, , Russia
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Yaroslavl, , Russia
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Cape Town, , South Africa
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Johannesburg, , South Africa
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Stellenbosch, , South Africa
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Daejeon, , South Korea
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Gwangju, , South Korea
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Jeju City, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Barcelona, , Spain
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Getafe, , Spain
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Mérida, , Spain
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Servilla, , Spain
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Vigo, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
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Doncaster, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Countries
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References
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Strand V, Kalunian KC, Lee KW, Seo C, Abreu G, Tummala R, Al-Mossawi H, Duncan EA, Lindholm C. Long-term effect of anifrolumab on patient-reported outcomes in systemic lupus erythematosus (TULIP-LTE): a randomised, placebo-controlled, phase 3 long-term extension trial. Lancet Rheumatol. 2025 Jul;7(7):e485-e494. doi: 10.1016/S2665-9913(25)00022-0. Epub 2025 May 2.
Tanaka Y, Atsumi T, Okada M, Miyamura T, Ishii T, Nishiyama S, Matsumura R, Kawakami A, Hayashi N, Abreu G, Yavuz S, Lindholm C, Al-Mossawi H, Takeuchi T. The long-term safety and tolerability of anifrolumab for patients with systemic lupus erythematosus in Japan: TULIP-LTE subgroup analysis. Mod Rheumatol. 2024 Jul 6;34(4):720-731. doi: 10.1093/mr/road092.
Kalunian KC, Furie R, Morand EF, Bruce IN, Manzi S, Tanaka Y, Winthrop K, Hupka I, Zhang LJ, Werther S, Abreu G, Hultquist M, Tummala R, Lindholm C, Al-Mossawi H. A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. 2023 Feb;75(2):253-265. doi: 10.1002/art.42392. Epub 2022 Nov 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D3461C00009
Identifier Type: -
Identifier Source: org_study_id
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