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Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

NCT ID: NCT01639339

Last Updated: 2021-03-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-12

Study Completion Date

2020-03-12

Brief Summary

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The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

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Detailed Description

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Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.

Conditions

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Lupus Nephritis

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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Placebo plus standard therapy

Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.

Group Type PLACEBO_COMPARATOR

Placebo plus standard therapy

Intervention Type BIOLOGICAL

Placebo plus standard therapy

Standard therapy

Intervention Type DRUG

The standard therapies allowed in this study are:

\- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy

OR

\- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy

Belimumab 10 mg/kg plus standard therapy

Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months.

Group Type EXPERIMENTAL

Belimumab 10 mg/kg plus standard therapy

Intervention Type BIOLOGICAL

Belimumab 10 mg/kg plus standard therapy

Standard therapy

Intervention Type DRUG

The standard therapies allowed in this study are:

\- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy

OR

\- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy

Interventions

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Placebo plus standard therapy

Placebo plus standard therapy

Intervention Type BIOLOGICAL

Belimumab 10 mg/kg plus standard therapy

Belimumab 10 mg/kg plus standard therapy

Intervention Type BIOLOGICAL

Standard therapy

The standard therapies allowed in this study are:

\- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy

OR

\- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy

Intervention Type DRUG

Other Intervention Names

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BENLYSTA™

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
* Biopsy confirmed active lupus nephritis.
* Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications.
* Autoantibody-positive.

Exclusion Criteria

* Pregnant or nursing.
* On dialysis within the past year.
* Treatment with belimumab within the past year .
* Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study.
* Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.
* Severe active central nervous system (CNS) lupus.
* Required management of acute or chronic infections within the past 60 days.
* Current drug or alcohol abuse or dependence.
* Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of severe allergic reaction to contrast agents or biological medicines.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Human Genome Sciences Inc., a GSK Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

La Palma, California, United States

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San Leandro, California, United States

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Torrance, California, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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St Louis, Missouri, 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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Manhasset, 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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Chapel Hill, North Carolina, United States

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Columbus, Ohio, United States

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Bethlehem, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Onalaska, Wisconsin, United States

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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Buenos Aires, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Córdoba, , Argentina

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Mendoza, , Argentina

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Brussels, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Belo Horizonte, Minas Gerais, Brazil

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Juiz de Fora, Minas Gerais, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Belo Horizonte, Minas Gerais, , Brazil

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Goiânia, , Brazil

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Lajeado, , Brazil

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Salvador, , Brazil

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Edmonton, Alberta, Canada

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Montreal, Quebec, Canada

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Wuhan, Hubei, China

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Changsha, Hunan, China

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Nanchang, Jiangxi, China

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Shenyang, Liaoning, China

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Chengdu, Sichuan, China

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Beijing, , China

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Chongqing, , China

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Fuzhou, , China

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Guangzhou, , China

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Nanning, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shenzhen, , China

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Xi'an, , China

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Bogotá, , Colombia

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Olomouc, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Cean Cedex 09, , France

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Créteil, , France

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Lille, , France

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Paris, , France

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Strasbourg, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Hanover, Lower Saxony, Germany

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Essen, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Dresden, Saxony, Germany

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Lübeck, Schleswig-Holstein, Germany

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Jena, Thuringia, Germany

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Berlin, , Germany

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Göttingen, , Germany

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Hong Kong, , Hong Kong

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Miskolc, , Hungary

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Szeged, , Hungary

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Guadalajara, Jalisco, Mexico

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Morelia, Michoacán, Mexico

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Cuernavaca, Morelos, Mexico

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México, , Mexico

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México, D.F., , Mexico

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Groningen, , Netherlands

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Leiden, , Netherlands

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Maastricht, , Netherlands

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Cebu City, , Philippines

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Davao City, , Philippines

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Iloilo City, , Philippines

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Lipa City, Batangas, , Philippines

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Manila, , Philippines

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Moscow, , Russia

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Orenburg, , Russia

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Saint Petersburg, , Russia

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Ufa, , Russia

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Busan, , South Korea

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Daejeon, , South Korea

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Daejeon, , South Korea

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Jeju Special Self-Governing Prov., , South Korea

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Jeonju, , 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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Seoul, , South Korea

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Suwon, , South Korea

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Suwon-si, Gyeonggi-do, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Palma de Mallorca, , Spain

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Valencia, , Spain

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Vigo/ Pontevedra, , Spain

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Gueishan Township,Taoyuan County, , Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Khon Kaen, , Thailand

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Muang, , Thailand

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Rajathevee, , Thailand

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Saimai, , Thailand

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London, , United Kingdom

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London, , United Kingdom

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Countries

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United States Argentina Belgium Brazil Canada China Colombia Czechia France Germany Hong Kong Hungary Mexico Netherlands Philippines Russia South Korea Spain Taiwan Thailand United Kingdom

References

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Sada K, Kurita N, Noma H, Matsuki T, Quasny H, Levy RA, Jones-Leone AR, Gairy K, Yajima N. MOONLIGHT study: the design of a comparative study of the effectiveness of belimumab in patients with a history of lupus nephritis from the post-Marketed effectiveness of belimumab cOhOrt and JapaN Lupus NatIonwide reGistry (LUNA) coHorT. Lupus Sci Med. 2022 Sep;9(1):e000746. doi: 10.1136/lupus-2022-000746.

Reference Type DERIVED
PMID: 37017254 (View on PubMed)

Furie R, Rovin BH, Houssiau F, Contreras G, Teng YKO, Curtis P, Green Y, Okily M, Madan A, Roth DA. Safety and Efficacy of Belimumab in Patients with Lupus Nephritis: Open-Label Extension of BLISS-LN Study. Clin J Am Soc Nephrol. 2022 Nov;17(11):1620-1630. doi: 10.2215/CJN.02520322. Epub 2022 Oct 27.

Reference Type DERIVED
PMID: 36302567 (View on PubMed)

Yu X, Chen N, Xue J, Mok CC, Bae SC, Peng X, Chen W, Ren H, Li X, Noppakun K, Gilbride JA, Green Y, Ji B, Liu C, Madan A, Okily M, Tang CH, Roth DA. Efficacy and Safety of Belimumab in Patients With Lupus Nephritis: Subgroup Analyses of a Phase 3 Randomized Trial in the East Asian Population. Am J Kidney Dis. 2023 Mar;81(3):294-306.e1. doi: 10.1053/j.ajkd.2022.06.013. Epub 2022 Sep 2.

Reference Type DERIVED
PMID: 36058429 (View on PubMed)

Rovin BH, Furie R, Teng YKO, Contreras G, Malvar A, Yu X, Ji B, Green Y, Gonzalez-Rivera T, Bass D, Gilbride J, Tang CH, Roth DA. A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. Kidney Int. 2022 Feb;101(2):403-413. doi: 10.1016/j.kint.2021.08.027. Epub 2021 Sep 22.

Reference Type DERIVED
PMID: 34560137 (View on PubMed)

Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180.

Reference Type DERIVED
PMID: 32937045 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2011-004570-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

114054

Identifier Type: -

Identifier Source: org_study_id

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