Belimumab Assessment of Safety in SLE
BASE
A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
3 other identifiers
interventional
4,019
32 countries
249
Brief Summary
The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2012
Longer than P75 for phase_4
249 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedStudy Start
First participant enrolled
November 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2018
CompletedResults Posted
Study results publicly available
November 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2022
CompletedJuly 15, 2024
July 1, 2024
5.7 years
October 10, 2012
July 19, 2019
July 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Deaths - On Treatment Period (Week 52)
Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than \[\>\]50 percent \[%\]) of the time. The on-treatment period was the primary analysis period for safety analyses.
Up to Week 52 (On-treatment period)
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)
A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale \[C-SSRS\]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.
Up to Week 52 (On-treatment period)
Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.
Up to Week 52 (On-treatment period)
Secondary Outcomes (6)
Number of Deaths Reported - On-study Period (Week 52)
Up to Week 52 (On-study period)
Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)
Up to Week 52 (On-study period)
Number of Participants With SAEs Reported During On-study Period (Week 52)
Up to Week 52 (On-study period)
Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52
Week 40 to Week 52
Number of Participants With All-cause Mortality During Years 2 to 5
From 2 years to 5 years
- +1 more secondary outcomes
Study Arms (2)
Placebo plus standard therapy
PLACEBO COMPARATORPlacebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.
Belimumab 10 mg/kg plus standard therapy
EXPERIMENTALBelimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.
Interventions
Belimumab 10 mg/kg plus standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).
You may not qualify if:
- Pregnant or nursing.
- Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
- Have received a live vaccine within the past 30 days.
- Have severe active lupus kidney disease.
- Have severe active central nervous system (CNS) lupus.
- Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (250)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Birmingham, Alabama, 35216, United States
GSK Investigational Site
Huntsville, Alabama, 35801, United States
GSK Investigational Site
Glendale, Arizona, 85304, United States
GSK Investigational Site
Mesa, Arizona, 85202, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Phoenix, Arizona, 85037, United States
GSK Investigational Site
Covina, California, 91722, United States
GSK Investigational Site
Huntington Beach, California, 92646, United States
GSK Investigational Site
La Mesa, California, 92020, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
Murrieta, California, 92563, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
San Leandro, California, 94578, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Hialeah, Florida, 33012, United States
GSK Investigational Site
Tampa, Florida, 33614, United States
GSK Investigational Site
Cedar Rapids, Iowa, 52403, United States
GSK Investigational Site
Saint Clair Shores, Michigan, 48081, United States
GSK Investigational Site
West Bloomfield, Michigan, 48322, United States
GSK Investigational Site
Jackson, Mississippi, 39216, United States
GSK Investigational Site
Kalispell, Montana, 59901, United States
GSK Investigational Site
Las Vegas, Nevada, 89128, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10032, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Charlotte, North Carolina, 28204, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Columbus, Ohio, 43203, United States
GSK Investigational Site
Duncansville, Pennsylvania, 16635, United States
GSK Investigational Site
Wyomissing, Pennsylvania, 19610, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Rock Hill, South Carolina, 29732, United States
GSK Investigational Site
Summerville, South Carolina, 29486, United States
GSK Investigational Site
Hixson, Tennessee, 37343-7908, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Cypress, Texas, 77429, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Houston, Texas, 77004, United States
GSK Investigational Site
Houston, Texas, 77034, United States
GSK Investigational Site
Houston, Texas, 77084, United States
GSK Investigational Site
McKinney, Texas, 75071, United States
GSK Investigational Site
Webster, Texas, 77450, United States
GSK Investigational Site
Arlington, Virginia, 22205-3606, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Beckley, West Virginia, 25801, United States
GSK Investigational Site
Clarksburg, West Virginia, 26301, United States
GSK Investigational Site
Capital Federal, Buenos Aires, 1425, Argentina
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Buenos Aires, 1035, Argentina
GSK Investigational Site
Ciudad Autonoma Buenos Aires, Buenos Aires, C1425ASQ, Argentina
GSK Investigational Site
La Plata, Buenos Aires, 1900, Argentina
GSK Investigational Site
Lanús, Buenos Aires, B1824KAJ, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600, Argentina
GSK Investigational Site
Zárate, Buenos Aires, 2800, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000BIF, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2002KDS, Argentina
GSK Investigational Site
Venado Tuerto, Santa Fe Province, 2600, Argentina
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, T4000BRD, Argentina
GSK Investigational Site
Buenos Aires, C1046AAQ, Argentina
GSK Investigational Site
Buenos Aires, C1425AGC, Argentina
GSK Investigational Site
Córdoba, 5004, Argentina
GSK Investigational Site
Mendoza, 5500, Argentina
GSK Investigational Site
San Miguel de Tucumán, T4000ICL, Argentina
GSK Investigational Site
Garran, Australian Capital Territory, 2605, Australia
GSK Investigational Site
Sydney, New South Wales, 2153, Australia
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
Fitzroy, Victoria, 3065, Australia
GSK Investigational Site
Cuiabá, Mato Grosso, 78.040-360, Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30130-100, Brazil
GSK Investigational Site
Juiz de Fora, Minas Gerais, 36010-570, Brazil
GSK Investigational Site
Curitiba, Paraná, 80440-080, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
GSK Investigational Site
Itajaí, Santa Catarina, 88301-220, Brazil
GSK Investigational Site
São José do Rio Preto, São Paulo, 15090-000, Brazil
GSK Investigational Site
São Paulo, São Paulo, 01244-030, Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30150-221, Brazil
GSK Investigational Site
Campinas, 13083-888, Brazil
GSK Investigational Site
Campo Grande, 79080-190, Brazil
GSK Investigational Site
Goiânia, 74110-120, Brazil
GSK Investigational Site
Lajeado, 95900-000, Brazil
GSK Investigational Site
Rio de Janeiro, 22411-001, Brazil
GSK Investigational Site
Salvador, 40050-410, Brazil
GSK Investigational Site
São Paulo, 01323-020, Brazil
GSK Investigational Site
São Paulo, 04032-060, Brazil
GSK Investigational Site
Pleven, 5800, Bulgaria
GSK Investigational Site
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Plovdiv, 4002, Bulgaria
GSK Investigational Site
Rousse, 7002, Bulgaria
GSK Investigational Site
Shumen, 9700, Bulgaria
GSK Investigational Site
Sofia, 1612, Bulgaria
GSK Investigational Site
Stara Zagora, 6001, Bulgaria
GSK Investigational Site
Targovisthe, 7700, Bulgaria
GSK Investigational Site
Veliko Tarnovo, 5000, Bulgaria
GSK Investigational Site
Brampton, Ontario, L6T 0G1, Canada
GSK Investigational Site
Vaughan, Ontario, L4L 4Y7, Canada
GSK Investigational Site
La Serena, 68650, Chile
GSK Investigational Site
Santigo, 7500010, Chile
GSK Investigational Site
Armenia, 55860, Colombia
GSK Investigational Site
Barranquilla, 080002, Colombia
GSK Investigational Site
Bogotá, 110111, Colombia
GSK Investigational Site
Bucaramanga, 680005, Colombia
GSK Investigational Site
Chía, 250007, Colombia
GSK Investigational Site
Medellín, 050018, Colombia
GSK Investigational Site
Osijek, 31000, Croatia
GSK Investigational Site
Rijeka, 51000, Croatia
GSK Investigational Site
Brno, 65691, Czechia
GSK Investigational Site
Prague, 128 50, Czechia
GSK Investigational Site
Prague, 150 06, Czechia
GSK Investigational Site
Zlín, 760 01, Czechia
GSK Investigational Site
Tallinn, 10117, Estonia
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Budapest, 1023, Hungary
GSK Investigational Site
Budapest, 1097, Hungary
GSK Investigational Site
Debrecen, 4031, Hungary
GSK Investigational Site
Debrecen, 4032, Hungary
GSK Investigational Site
Gyula, 5700, Hungary
GSK Investigational Site
Zalaegerszeg, 8900, Hungary
GSK Investigational Site
Bandung, 40161, Indonesia
GSK Investigational Site
Denpasar, 80114, Indonesia
GSK Investigational Site
Malang, 65111, Indonesia
GSK Investigational Site
Palembang, 30126, Indonesia
GSK Investigational Site
Yogyakarta, 55281, Indonesia
GSK Investigational Site
Rome, Lazio, 00151, Italy
GSK Investigational Site
Milan, Lombardy, 20132, Italy
GSK Investigational Site
Florence, Tuscany, 50134, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Pisa, 56126, Italy
GSK Investigational Site
Klaipėda, LT-92288, Lithuania
GSK Investigational Site
Ipoh, 30990, Malaysia
GSK Investigational Site
Kota Bharu, 15586, Malaysia
GSK Investigational Site
Kota Kinabalu, 88586, Malaysia
GSK Investigational Site
Kuala Lumpur, 56000, Malaysia
GSK Investigational Site
Kuala Selangor, 68100, Malaysia
GSK Investigational Site
Kuala Terengganu, 20400, Malaysia
GSK Investigational Site
Seremban, Negeri Sembilan, 70300, Malaysia
GSK Investigational Site
Torreón, Coahuila, 27000, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44158, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44690, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64718, Mexico
GSK Investigational Site
Cuautitlán Izcalli, State of Mexico, 54769, Mexico
GSK Investigational Site
Mérida, Yucatán, 97130, Mexico
GSK Investigational Site
D.F, 6726, Mexico
GSK Investigational Site
Guadalajara, 44620, Mexico
GSK Investigational Site
México, 14000, Mexico
GSK Investigational Site
México, 7760, Mexico
GSK Investigational Site
San Luis Potosí City, 78200, Mexico
GSK Investigational Site
San Luis Potosí City, 78240, Mexico
GSK Investigational Site
Torreón, 27000, Mexico
GSK Investigational Site
Auckland, 622, New Zealand
GSK Investigational Site
Wellington, 6011, New Zealand
GSK Investigational Site
Arequipa, 4017, Peru
GSK Investigational Site
Lima, 01, Peru
GSK Investigational Site
Lima, 11, Peru
GSK Investigational Site
Lima, 15048, Peru
GSK Investigational Site
Lima, Lima 29, Peru
GSK Investigational Site
Lima, Lima 31, Peru
GSK Investigational Site
Lima, Lima 33, Peru
GSK Investigational Site
Lima, Lima 41, Peru
GSK Investigational Site
Angeles City, Pampanga, 2009, Philippines
GSK Investigational Site
Cebu City, 6000, Philippines
GSK Investigational Site
Davao City, 8000, Philippines
GSK Investigational Site
Iloilo City, 5000, Philippines
GSK Investigational Site
Las Piñas, 1740, Philippines
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Manila, 1510, Philippines
GSK Investigational Site
Quezon City, 1102, Philippines
GSK Investigational Site
Bydgoszcz, 85-168, Poland
GSK Investigational Site
Gdansk, 80-952, Poland
GSK Investigational Site
Krakow, 31-066, Poland
GSK Investigational Site
Almada, 2801-915, Portugal
GSK Investigational Site
Coimbra, 3000-075, Portugal
GSK Investigational Site
Lisbon, 1050-034, Portugal
GSK Investigational Site
Lisbon, 1649-035, Portugal
GSK Investigational Site
Porto, 4099-001, Portugal
GSK Investigational Site
Porto, 4200-319, Portugal
GSK Investigational Site
Viseu, 3504-509, Portugal
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Galati, 800578, Romania
GSK Investigational Site
Târgu Mureş, 540142, Romania
GSK Investigational Site
Barnaul, 656045, Russia
GSK Investigational Site
Kemerovo, 650066, Russia
GSK Investigational Site
Kursk, 305007, Russia
GSK Investigational Site
Moscow, 119991, Russia
GSK Investigational Site
Saint Petersburg, 190068, Russia
GSK Investigational Site
Saint Petersburg, 194044, Russia
GSK Investigational Site
Saratov, 410053, Russia
GSK Investigational Site
Belgrade, 11000, Serbia
GSK Investigational Site
Belgrade, 11080, Serbia
GSK Investigational Site
Kruševac, 37000, Serbia
GSK Investigational Site
Niška Banja, 18205, Serbia
GSK Investigational Site
Šabac, 15000, Serbia
GSK Investigational Site
Piešťany, 921 12, Slovakia
GSK Investigational Site
Daegu, 700-721, South Korea
GSK Investigational Site
Daejeon, 301-721, South Korea
GSK Investigational Site
Daejeon, 302-799, South Korea
GSK Investigational Site
Gwangju, 501-757, South Korea
GSK Investigational Site
Incheon, 400-711, South Korea
GSK Investigational Site
Jeonju, 561-712, South Korea
GSK Investigational Site
Seoul, 110-744, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Seoul, 133-792, South Korea
GSK Investigational Site
Seoul, 137-701, South Korea
GSK Investigational Site
Seoul, 143-729, South Korea
GSK Investigational Site
Suwon, 16247, South Korea
GSK Investigational Site
Suwon, 443-380, South Korea
GSK Investigational Site
Barcelona, 8035, Spain
GSK Investigational Site
Bilbao, 48013, Spain
GSK Investigational Site
Castellon, 12004, Spain
GSK Investigational Site
Córdoba, 140044, Spain
GSK Investigational Site
Getafe/Madrid, 28905, Spain
GSK Investigational Site
Granada, 18012, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Málaga, 29009, Spain
GSK Investigational Site
Seville, 41009, Spain
GSK Investigational Site
Seville, 4110, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Valencia, 46026, Spain
GSK Investigational Site
Vilajoyosa, 3570, Spain
GSK Investigational Site
Sankt Gallen, 9007, Switzerland
GSK Investigational Site
Zurich, 8006, Switzerland
GSK Investigational Site
Chiayi County, 613, Taiwan
GSK Investigational Site
Gueishan Township,Taoyuan County, 333, Taiwan
GSK Investigational Site
Kaohsiung City, 833, Taiwan
GSK Investigational Site
Taichung, 402, Taiwan
GSK Investigational Site
Taichung, 404, Taiwan
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taipei, 106, Taiwan
GSK Investigational Site
Taipei, 11490, Taiwan
GSK Investigational Site
Bangkok, 10400, Thailand
GSK Investigational Site
Bangkok, 10700, Thailand
GSK Investigational Site
Chiang Mai, 50200, Thailand
GSK Investigational Site
Chernivtsi, 58001, Ukraine
GSK Investigational Site
Donetsk, 83045, Ukraine
GSK Investigational Site
Donetsk, 83114, Ukraine
GSK Investigational Site
Ivano-Frankivsk, 76018, Ukraine
GSK Investigational Site
Kharkiv, 61176, Ukraine
GSK Investigational Site
Kyiv, 1601, Ukraine
GSK Investigational Site
Kyiv, 4114, Ukraine
GSK Investigational Site
Lviv, 79010, Ukraine
GSK Investigational Site
Odesa, 65026, Ukraine
GSK Investigational Site
Poltava, 36011, Ukraine
GSK Investigational Site
Ternopil, 46002, Ukraine
GSK Investigational Site
Uzhhorod, 88018, Ukraine
GSK Investigational Site
Vinnytsia, 21018, Ukraine
GSK Investigational Site
Vinnytsia, 21029, Ukraine
GSK Investigational Site
Zaporizhzhia, 69600, Ukraine
Related Publications (2)
Sheikh S, Scheinberg MA, Wei CC, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello M, Maksimowicz-McKinnon K, Abud Mendoza C, Navarra S, Garcia M, Garcia de la Torre I, Ordi Ros J, Nami A, Levy R, Bass D, Ross J, Punwaney R, Harris J, Pierce A, Thorneloe K, Ji B, Roth D. Mortality and adverse events of special interest in adult patients with active, auto-antibody-positive systemic lupus erythematosus receiving intravenous belimumab (BASE): a global, randomised, double-blind, placebo-controlled, multicentre Phase 4 trial. Lancet Rheumatol. 2020; DOI: 10.1016/S2665-9913(20)30355-6
BACKGROUNDSheikh SZ, Scheinberg MA, Wei JC, Tegzova D, Stohl W, de Toledo RA, Mucenic T, Banfi MRA, Maksimowicz-McKinnon K, Abud-Mendoza C, Navarra S, Garcia M, Garcia-De La Torre I, Ros JO, Levy RA, Bass DL, Terres JR, Punwaney R, Harris J, Nami A, Pierce A, Thorneloe KS, Ji B, Roth DA. Mortality and adverse events of special interest with intravenous belimumab for adults with active, autoantibody-positive systemic lupus erythematosus (BASE): a multicentre, double-blind, randomised, placebo-controlled, phase 4 trial. Lancet Rheumatol. 2021 Feb;3(2):e122-e130. doi: 10.1016/S2665-9913(20)30355-6. Epub 2020 Dec 15.
PMID: 38279368DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2012
First Posted
October 15, 2012
Study Start
November 27, 2012
Primary Completion
July 30, 2018
Study Completion
August 10, 2022
Last Updated
July 15, 2024
Results First Posted
November 29, 2019
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study is available via the Clinical Study Data Request site.