Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

461

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

April 30, 2012

Study Completion Date

October 31, 2012

Conditions
Lupus Erythematosus, Systemic
Interventions
DRUG

Atacicept 75 mg

75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

DRUG

Atacicept 150 mg

150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

OTHER

Placebo Comparator

Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Trial Locations (113)

10021

Hospital for Special Surgey, New York

11030

Feinstein Institute for Medical Research, Manhasset

48201

Wayne State University, Detroit

48910

Justus J. Fiechtner, MD, MPH, Lansing

35249-7201

Division of Clinical Immunology and Rheumatology - UAB, Birmingham

Unknown

Stanford University, Palo Alto

Research Site, San Diego

Inland Rheumatology Clinical Trials Inc, Upland

Research Site, Jacksonville

Research Site, Boise

SUNY Health Science Center at Brooklyn, Brooklyn

Research Site, New York

Research Site, Cincinnati

University of Cincinnati Medical Center, Division of Immunology, Cincinnati

Research Site, Temple

Virginia Mason Medical Center, Seattle

Research Site, Buenos Aires

Research Site, Córdoba

Research Site, Quilmes

Research Site, San Juan

Research Site, San Miguel de Tucumán

Research Site, Cairns

Research Site, Clayton, Victoria

Research Site, Sunshine Coast, Queensland

Research Site, Woodville S.A.

Research Site, Wein

Research Site, Sofia

Research Site, Osijek

Research Site, Rijeka

Research Site, Split

Research Site, Zagreb

Research Site, Prague

Research Site, Bordeaux Pessac

Research Site, Lille

Research Site, Montpelier Cedex

Research Site, Paris

Research Site, Strasbourg

Research Site, Toulouse

Research Site, Berlin

Research Site, Erlangen

Research Site, Hanover

Research Site, Heidelberg

Research Site, Herne

Research Site, München

Research Site, Münster

Research Site, Athens

Research Site, Thessaloniki

Research Site, Secunderabad, Andhra Pradesh

Research Site, Haifa

Research Site, Jerasalem

Research Site, Petah Tikva

Research Site, Tel Aviv

Research Site, Riga

Research Site, Beirut

Research Site, Kaunas

Research Site, Vilnius

Research Site, Kuala Lumpur

Research Site, Perak

Research Site, Seremban

Research Site, Guadalajara Jalisco

Research Site, Tijuana, BC

Research Site, Amsterdam

Research Site, Leiden

Research Site, Maastricht

Research Site, Angeles City

Research Site, Davao City

Research Site, Iloilo City

Research Site, Las Piñas

Research Site, Manila

Research Site, Bialystok

Research Site, Gdansk

Research Site, Krakow

Research Site, Lublin

Research Site, Szczecin

Research Site, Torun

Research Site, Warsaw

Research Site, Kemerovo

Research Site, Petrozavodsk

Research Site, Ryazan

Research Site, Saint Petersburg

Research Site, Saratov

Research Site, Tula

Research Site, Yaroslavl

Research Site, Belgrade

Research Site, New Belgrade

Research Site, Niška Banja

Research Site, Cape Town

Research Site, Durban

Research Site, Panorama, Western Cape

Research Site, Parlow, Western Cape

Research Site, Pinelands

Research Site, Stellenbosch, Western Cape

Research Site, Gyeonggi-do

Research Site, Seoul

Research Site, Barcelona

Research Site, Madrid

Research Site, Málaga

Research Site, Santiago de Compostela

Research Site, Sankt Gallen

Research Site, Taichung

Research Site, Taipei

Research Site, Taoyuan District

Research Site, Donetsk

Research Site, Kharkiv

Research Site, Kyiv

Research Site, Lviv

Research Site, Ternopil

Research Site, Vinnytsia

Research Site, Zhytomyr

Research Site, London

Research Site, Manchester

02115

Brigham and Women's Hospital, Boston

02370

US Local Medical Information, Rockland

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono

INDUSTRY

NCT00624338 - Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) | Biotech Hunter | Biotech Hunter