Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02794285




Registration number
NCT02794285
Ethics application status
Date submitted
6/06/2016
Date registered
9/06/2016
Date last updated
13/01/2023

Titles & IDs
Public title
Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
Scientific title
A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.
Secondary ID [1] 0 0
D3461C00009
Universal Trial Number (UTN)
Trial acronym
TULIP SLE LTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Anifrolumab
Treatment: Drugs - Placebo

Experimental: Anifrolumab - Anifrolumab

Placebo comparator: Placebo - Placebo


Treatment: Other: Anifrolumab
Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses

Treatment: Drugs: Placebo
Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs)
Timepoint [1] 0 0
Up to a maximum of 1114 days
Primary outcome [2] 0 0
EAIRs of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to a maximum of 1114 days

Eligibility
Key inclusion criteria
1. Subjects who have qualified for and received investigational product (anifrolumab or placebo) and completed the treatment period in Studies D3461C00004 or D3461C00005 (through Week 52)
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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receipt of any of the following within the last 60 days:

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2021
Sample size
Target
Accrual to date
Final
559
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Fitzroy
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
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Florida
Country [6] 0 0
United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
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Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Mendoza
Country [25] 0 0
Argentina
State/province [25] 0 0
Quilmes
Country [26] 0 0
Argentina
State/province [26] 0 0
San Miguel de Tucuman
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Plovdiv
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Chile
State/province [30] 0 0
Osorno
Country [31] 0 0
Chile
State/province [31] 0 0
Santiago
Country [32] 0 0
Chile
State/province [32] 0 0
Vina del Mar
Country [33] 0 0
Colombia
State/province [33] 0 0
Armenia
Country [34] 0 0
Colombia
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Barranquilla
Country [35] 0 0
Colombia
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Medellín
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France
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Bordeaux
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France
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Lille
Country [38] 0 0
France
State/province [38] 0 0
Montpellier CEDEX 5
Country [39] 0 0
France
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Paris Cedex 13
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France
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Paris cedex 14
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France
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Pessac
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Germany
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Berlin
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Germany
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Frankfurt am Main
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Germany
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Hamburg
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Germany
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Jena
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Germany
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Kirchheim
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Germany
State/province [47] 0 0
Mainz Am Rhein
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
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Hungary
State/province [49] 0 0
Debrecen
Country [50] 0 0
Hungary
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Szeged
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Hungary
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Zalaegerszeg
Country [52] 0 0
Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Tel Aviv
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Japan
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Chiba-shi
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Japan
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Chuo-ku
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Japan
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Fukuoka-shi
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Japan
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Hiroshima-shi
Country [60] 0 0
Japan
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Kitakyushu-shi
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Japan
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Kurashiki-shi
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Japan
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Meguro-ku
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Japan
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Nagasaki-shi
Country [64] 0 0
Japan
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Omura-shi
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Japan
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Sapporo-shi
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Japan
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Sasebo-shi
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Japan
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Sendai-shi
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Japan
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Shinjuku-ku
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Korea, Republic of
State/province [69] 0 0
Daejeon
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Korea, Republic of
State/province [70] 0 0
Gwangju
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Korea, Republic of
State/province [71] 0 0
Jeju-si
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Korea, Republic of
State/province [72] 0 0
Seoul
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Korea, Republic of
State/province [73] 0 0
Suwon-si
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Mexico
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Chihuahua
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Mexico
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Leon
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Mexico
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Mexico D.F.
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Mexico
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Mexico
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Mexico
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Mérida
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Mexico
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San Luis Potosí
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Koscian
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Poland
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Kraków
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Poland
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Lublin
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Poland
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Nadarzyn
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Poland
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Starachowice
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Poland
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Szczecin
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Poland
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Ustron
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Poland
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Warszawa
Country [94] 0 0
Romania
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Brasov
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Romania
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Bucuresti
Country [96] 0 0
Romania
State/province [96] 0 0
Cluj Napoca
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Romania
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Galati
Country [98] 0 0
Romania
State/province [98] 0 0
Targu Mures
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Smolensk
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Russian Federation
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Tolyatti
Country [101] 0 0
Russian Federation
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Vladimir
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Russian Federation
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Yaroslavl
Country [103] 0 0
South Africa
State/province [103] 0 0
Cape Town
Country [104] 0 0
South Africa
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Johannesburg
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South Africa
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Stellenbosch
Country [106] 0 0
Spain
State/province [106] 0 0
Barcelona
Country [107] 0 0
Spain
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Getafe
Country [108] 0 0
Spain
State/province [108] 0 0
Mérida
Country [109] 0 0
Spain
State/province [109] 0 0
Servilla
Country [110] 0 0
Spain
State/province [110] 0 0
Vigo
Country [111] 0 0
Taiwan
State/province [111] 0 0
Kaohsiung
Country [112] 0 0
Taiwan
State/province [112] 0 0
Taichung
Country [113] 0 0
Taiwan
State/province [113] 0 0
Taipei
Country [114] 0 0
Ukraine
State/province [114] 0 0
Kyiv
Country [115] 0 0
Ukraine
State/province [115] 0 0
Lviv
Country [116] 0 0
Ukraine
State/province [116] 0 0
Ternopil
Country [117] 0 0
Ukraine
State/province [117] 0 0
Uzhhorod
Country [118] 0 0
Ukraine
State/province [118] 0 0
Vinnytsia
Country [119] 0 0
Ukraine
State/province [119] 0 0
Zaporizhzhia
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Doncaster
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Leeds
Country [122] 0 0
United Kingdom
State/province [122] 0 0
London
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PRA Health Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kenneth Kalunian, MD
Address 0 0
University of California, San Diego
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02794285