A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT00410384
Last Updated: 2017-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
819 participants
INTERVENTIONAL
2006-12-31
2010-03-31
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
DOUBLE
Study Groups
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Placebo
Placebo
Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg
Belimumab 1 mg/kg
Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg
Belimumab 10 mg/kg
Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Interventions
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Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active SLE disease.
* Autoantibody-positive.
* On stable SLE treatment regimen.
Exclusion Criteria
* Have received treatment with any B cell targeted therapy.
* Have received treatment with a biological investigational agent in the past year.
* Have received IV cyclophosphamide within 180 days of Day 0.
* Have severe lupus kidney disease.
* Have active central nervous system (CNS) lupus.
* Have required management of acute or chronic infections within the past 60 days.
* Have current drug or alcohol abuse or dependence.
* Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
Human Genome Sciences Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research, PPLC
Paradise Valley, Arizona, United States
The University of Arizona Arthritis Center
Tucson, Arizona, United States
Talbert Medical Group
Huntington Beach, California, United States
Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
Wallace Rheumatic Study Center
Los Angeles, California, United States
UCLA Rheumatology
Los Angeles, California, United States
Arthritis Care Center, Inc.
San Jose, California, United States
Inland Rheumatic Disease Specialties
Upland, California, United States
Arthritis Associates of Colorado Springs
Colorado Springs, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
University of Miami-Division of Rheumatology and Immunology
Miami, Florida, United States
Rheumatology Associates of Central Florida
Orlando, Florida, United States
Southwest Florida Clinical Research Center
Tampa, Florida, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Selah Medical Clinical Research Unit
Boise, Idaho, United States
Rheumatology Associates, SC
Chicago, Illinois, United States
University of Chicago Hospitals
Chicago, Illinois, United States
Medical Specialists Clinical Research
Munster, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Kentuckiana Center for Better Bone and Joint Health
Louisville, Kentucky, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Osteoporosis and Clinical Trials Center
Cumberland, Maryland, United States
Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
University of Michigan Medical Center - Regents of University of Michigan
Ann Arbor, Michigan, United States
Fiechtner Research, Inc.
Lansing, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Stafford Medical Associates, PA
Dover, New Hampshire, United States
SUNY-Downstate Medical Center
Brooklyn, New York, United States
North Shore-LIJ Health System/Rheumatology and Allergy Clinic
Lake Success, New York, United States
Feinstein Institute
Manhasset, New York, United States
Hopital for Joint Diseases
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
AAIR Research Center
Rochester, New York, United States
Rheumatology Associates
Smithtown, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Physicians East, PA
Greenville, North Carolina, United States
Wake Forest University Health Services
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
STAT Research, Inc.
Dayton, Ohio, United States
Oklahoma Medical Research Center
Oklahoma City, Oklahoma, United States
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States
Altoona Center for Clinical Research
Duncanville, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Low Country Rheumatology, PA/Low Country Research Center
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Palmetto Clinical Trial at Piedmont Arthritis Clinic
Greenville, South Carolina, United States
Walter Chase
Austin, Texas, United States
University of Texas - Southwestern Medical Center
Dallas, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
The Rheumatic Disease Clinical Research Center
Houston, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Houston Institute for Clinical Research
Houston, Texas, United States
Arthritis Center of South Texas
San Antonio, Texas, United States
Texas Research Center
Sugar Land, Texas, United States
Rheumatology Clinic
Salt Lake City, Utah, United States
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, United States
The Seattle Arthritis Clinic
Seattle, Washington, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
Gundersen Clinic, Ltd.
Onalaska, Wisconsin, United States
Universitatsklinik fur innere Medizin
Graz, , Austria
Rheumazentrum Favoriten
Vienna, , Austria
Cliniques Universitaires
Brussels, , Belgium
University Hospital
Leuven, , Belgium
CHU Sart Tilman
Liège, , Belgium
Toronto Western Hospital
Toronto, Ontario, Canada
Centre for Prognosis Studies in Rheaumatic Diseases
Toronto, Ontario, Canada
McGill University Health Centre, Montreal General Hospital
Montreal, , Canada
Hospital Clinica Biblica
San José, , Costa Rica
University Hospital Brno
Brno, , Czechia
University Hospital Hradec Kralove
Hradec Králové, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
Institute of Rheumatology
Prague, , Czechia
CHU Hospital de Bicetre
Le Kremlin-Bicêtre, , France
Hospital Huriez
Lille, , France
Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
Stasbourg, , France
Hospital FOCH
Suresnes, , France
Centre Hospitalier Universitarie (CHU) - PURPAA
Toulouse, , France
Kerckhoff-Klink Bad Nauheim
Bad Nauheim, , Germany
Schlossparkklinik
Berlin, , Germany
Charite
Berlin, , Germany
Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
Düsseldorf, , Germany
FA Universitat Erlangen Nurnberg
Erlangen, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Medizinische Universitatsklinik
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Friedrich Schiller Universitat
Jena, , Germany
Universitatsklinik Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Universitatsklinik Mainz
Mainz, , Germany
Universitatsklinikum Tubingen
Tübingen, , Germany
Soroka University Medical Center
Beersheba, , Israel
B'nai-Zion Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Beilinson Hospital, Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel-Aviv Saurasky Medical Center
Tel Aviv, , Israel
A. O. Ospedaliera-Universitaria Arcispedale
Ferrara, , Italy
A.O. Ospedale San Carlo Borromeo
Milan, , Italy
Policlinico di Modena
Modena, , Italy
Policlinico Universitario of Padova
Padua, , Italy
A.O. San Camillo
Rome, , Italy
Policlinico Umberto 1
Rome, , Italy
U.O. di reumatologia Presidio Ospedaliero di Scafati
Scafati, , Italy
Azienda Ospedaliero University-Santa Maria della Misericordia
Udine, , Italy
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, , Mexico
Instituto Jalisciense de Investigacion Clinica
Jalisco, , Mexico
Hospital General de México
Mexico City, , Mexico
Hospital Regional 1o de Octubre - ISSSTE
Mexico City, , Mexico
Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin
Mexico City, , Mexico
Hospital Central de S.L.P. "Iganico Morones Prieto"
San Luis Potosí City, , Mexico
Instituto de Seguridad Social del Estado de Mexico y Municipios
Toluca, , Mexico
Leiden University Medical Center
Leiden, , Netherlands
University Medical Center Maastricht
Maastricht, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Szpital Uniwerytecki nr Zim. dr. Jana Biziela
Bydgoszcz, , Poland
Szpital Specjalistyczny Sw. Lukasza
Gmina Końskie, , Poland
Malopolskie Centrum Medyczne
Krakow, , Poland
Gabinety Profesorow Osrodek Baden Klinicznych
Lublin, , Poland
Klinika Reumatologii im Prof. Eleonory Reicher
Warsaw, , Poland
Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
Wroclaw, , Poland
Ponce School of Medicine
Ponce, , Puerto Rico
University of Puerto Rico Medical Center
Rio Piedras, , Puerto Rico
Spitalul Clinic "Sf Maria"
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Narodny Ustav Reumatickych Chorob
Piešťany, , Slovakia
Hospital La Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial Barcelona
Barcelona, , Spain
Hospital Universitario San Cecilio
Granada, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Son Dureta
Mallorca, , Spain
Hospital Regional Universitario de SAS - Carlos Haya
Málaga, , Spain
Sahlgrensja University Hospital
Gothenburg, , Sweden
Karolinska Universitetssjukhuset
Stockholm, , Sweden
St. Thomas Hospital
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Botto J, Cetrez N, Nikolopoulos D, Regardt M, Heintz E, Lindblom J, Parodis I. Predicting EQ-5D full health state in systemic lupus erythematosus using machine learning algorithms. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkaf032. doi: 10.1093/rap/rkaf032. eCollection 2025.
Nikolopoulos D, Cetrez N, Lindblom J, Parodis I. Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials. Rheumatol Int. 2024 Sep;44(9):1679-1689. doi: 10.1007/s00296-024-05667-5. Epub 2024 Aug 8.
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Jesus D, Henriques C, Matos A, Doria A, Ines LS. Systemic Lupus Erythematosus Disease Activity Score Remission and Low Disease Activity States Discriminate Drug From Placebo and Better Health-Related Quality of Life. Arthritis Care Res (Hoboken). 2024 Jun;76(6):788-795. doi: 10.1002/acr.25305. Epub 2024 Feb 29.
Jagerback S, Gomez A, Parodis I. Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). 2025 Feb 1;64(2):623-631. doi: 10.1093/rheumatology/keae023.
Gomez A, Jagerback S, Sjowall C, Parodis I. Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials. Rheumatology (Oxford). 2024 Feb 1;63(2):338-348. doi: 10.1093/rheumatology/kead253.
Emamikia S, Oon S, Gomez A, Lindblom J, Borg A, Enman Y, Morand E, Grannas D, van Vollenhoven RF, Nikpour M, Parodis I. Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2022 Nov 28;61(12):4752-4762. doi: 10.1093/rheumatology/keac185.
Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x.
Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1):e000459. doi: 10.1136/lupus-2020-000459.
Gomez A, Hani Butrus F, Johansson P, Akerstrom E, Soukka S, Emamikia S, Enman Y, Pettersson S, Parodis I. Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Mar 2;60(3):1260-1272. doi: 10.1093/rheumatology/keaa453.
van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.
Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials. Lupus Sci Med. 2014 Jun 26;1(1):e000031. doi: 10.1136/lupus-2014-000031. eCollection 2014.
Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.
Strand V, Levy RA, Cervera R, Petri MA, Birch H, Freimuth WW, Zhong ZJ, Clarke AE; BLISS-52 and -76 Study Groups. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. 2014 May;73(5):838-44. doi: 10.1136/annrheumdis-2012-202865. Epub 2013 Mar 22.
Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.
Chatham WW, Wallace DJ, Stohl W, Latinis KM, Manzi S, McCune WJ, Tegzova D, McKay JD, Avila-Armengol HE, Utset TO, Zhong ZJ, Hough DR, Freimuth WW, Migone TS; BLISS-76 Study Group. Effect of belimumab on vaccine antigen antibodies to influenza, pneumococcal, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial. J Rheumatol. 2012 Aug;39(8):1632-40. doi: 10.3899/jrheum.111587. Epub 2012 Jun 15.
van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. doi: 10.1136/annrheumdis-2011-200937. Epub 2012 Feb 15.
Stohl W, Hiepe F, Latinis KM, Thomas M, Scheinberg MA, Clarke A, Aranow C, Wellborne FR, Abud-Mendoza C, Hough DR, Pineda L, Migone TS, Zhong ZJ, Freimuth WW, Chatham WW; BLISS-52 Study Group; BLISS-76 Study Group. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Jul;64(7):2328-37. doi: 10.1002/art.34400.
Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzova D, Sanchez-Guerrero J, Schwarting A, Merrill JT, Chatham WW, Stohl W, Ginzler EM, Hough DR, Zhong ZJ, Freimuth W, van Vollenhoven RF; BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918-30. doi: 10.1002/art.30613.
Study Documents
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Document Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Other Identifiers
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BLISS-76
Identifier Type: -
Identifier Source: secondary_id
110751
Identifier Type: OTHER
Identifier Source: secondary_id
HGS1006-C1056
Identifier Type: -
Identifier Source: org_study_id
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