A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

PHASE2CompletedINTERVENTIONAL
Enrollment

834

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

November 14, 2013

Study Completion Date

April 17, 2014

Conditions
Systemic Lupus Erythematosus
Interventions
BIOLOGICAL

Sifalimumab 200 mg

Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

BIOLOGICAL

Sifalimumab 600 mg

Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

BIOLOGICAL

Sifalimumab 1,200 mg

Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.

OTHER

Placebo

IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks

Trial Locations (107)

Unknown

Research Site, La Jolla

Research Site, Palm Desert

Research Site, San Leandro

Research Site, Fort Lauderdale

Research Site, Orlando

Research Site, Stockbridge

Research Site, Idaho Falls

Research Site, Shreveport

Research Site, Baltimore

Research Site, Lansing

Research Site, Brooklyn

Research Site, Manhasset

Research Site, New York

Research Site, Charlotte

Research Site, Raleigh

Research Site, Dallas

Research Site, Seattle

Research Site, Buenos Aires

Research Site, Ciudad Autonoma de Buenos Aire

Research Site, Ciudad de Buenos Aires

Research Site, La Plata

Research Site, Quilmes

Research Site, San Miguel de Tucumán

Research Site, Curitiba

Research Site, Goiânia

Research Site, Juiz de Fora

Research Site, Porto Alegre

Research Site, Salvador

Research Site, São Paulo

Research Site, Plovdiv

Research Site, Sofia

Research Site, Québec

Research Site, Sherbrooke

Research Site, Osorno

Research Site, Santiago

Research Site, Viña del Mar

Research Site, Bordeaux

Research Site, Le Kremlin-Bicêtre

Research Site, Paris

Research Site, Strasbourg

Research Site, Berlin

Research Site, Cologne

Research Site, Dresden

Research Site, Frankfurt

Research Site, Kiel

Research Site, Leipzig

Research Site, Mainz

Research Site, Münster

Research Site, Regensburg

Research Site, Würzburg

Research Site, Budapest

Research Site, Debrecen

Research Site, Miskolc

Research Site, Zalaegerszeg

Research Site, Bangalore

Research Site, Secunderabad

Research Site, Brescia

Research Site, Florence

Research Site, Milan

Research Site, Padua

Research Site, Pisa

Research Site, Roma

Research Site, Kingston

Research Site, Chihuahua City

Research Site, Guadalajara

Research Site, México

Research Site, San Luis Potosí City

Research Site, Amsterdam

Research Site, Lima

Research Site, San Borja

Research Site, Cebu City

Research Site, Iloilo City

Research Site, Manila

Research Site, Bialystok

Research Site, Bydgoszcz

Research Site, Katowice

Research Site, Krakow

Research Site, Lublin

Research Site, Olsztyn

Research Site, Poznan

Research Site, Warsaw

Research Site, Brasov

Research Site, Bucharest

Research Site, Cluj-Napoca

Research Site, Tg Mures

Research Site, Cape Town

Research Site, Durban

Research Site, Johannesburg

Research Site, Pinelands

Research Site, Soweto

Research Site, Barcelona

Research Site, Guadalajara

Research Site, La Laguna (Tenerife)

Research Site, Madrid

Research Site, Majadahonda

Research Site, Málaga

Research Site, Mérida

Research Site, Santiago de Compostela

Research Site, Seville

Research Site, Bangkok

Research Site, Brighton

Research Site, Cambridge

Research Site, Cannock

Research Site, Guildford

Research Site, Leeds

Research Site, London

Research Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY

NCT01283139 - A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter