Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

PHASE2CompletedINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

April 30, 2016

Study Completion Date

September 30, 2016

Conditions
Lupus Erythematosus, Systemic
Interventions
DRUG

Atacicept 75 milligram (mg)

Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.

DRUG

Atacicept 150 mg

Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.

DRUG

Placebo

Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.

Trial Locations (138)

10021

Hospital for Special Surgery, New York

11031

The Feinstein Institute for Medical Research, Manhasset

19610

Clinical Research Center of Reading LLC, Wyomissing

24541

Danville Orthopedic Clinic, Inc., Danville

28210

Box Arthritis & Rheumatology of the Carolinas PLLC, Charlotte

29425

Medical University of South Carolina (MUSC), Charleston

33136

University of Miami Miller School of Medicine, Miami

33309

Center for Rheumatology, Immunology & Arthritis, Fort Lauderdale

33603

Clinical Research of West Florida, Inc., Tampa

34698

Clinical Research of West Florida - Corporate, Dunedin

35216

Achieve Clinical Research, LLC, Birmingham

35294

University of Alabama at Birmingham - (UAB), Birmingham

36207

Pinnacle Research Group LLC, Anniston

38801

North MS Medical Clinics, Inc., Tupelo

43210

Ohio State University Medical Center, Columbus

44109

MetroHealth System, Cleveland

45417

STAT Research, Inc., Dayton

46260

Goldpoint Clinical Research, LLC, Indianapolis

48439

AA MRC LLC Ahmed Arif Medical Research Center, Grand Blanc

55905

Mayo Clinic, Rochester

63110

Washington University School of Medicine, St Louis

73103

Arthritis & Rheumatology Center of Oklahoma, Oklahoma City

73104

OMRF, Oklahoma City

73112

Lynn Health Science Institute, Oklahoma City

76708

Arthritis & Osteoporosis Clinic, Waco

77555

UTMB Pathology Clinical Services, Galveston

90048

Wallace Rheumatic Study Center, Los Angeles

92806

Southern California Permanente Medical Group, Anaheim

94578

East Bay Rheumatology Medical Group, Inc., San Leandro

07103

Rutgers New Jersey Medical School, Newark

Unknown

APRILLUS, Ciudad Autonoma Buenos Aires

Atencion Integral en Reumatologia (AIR), Ciudad Autonoma Buenos Aires

Hospital Italiano, Ciudad Autonoma Buenos Aires

Organizacion Medica de Investigacion (OMI), Ciudad Autonoma Buenos Aires

Policlìnica Red Omip S.A - Ensayos Clinicos GC, Mar del Plata

Centro de Investigacion Pergamino SA, Pergamino

Cordis S.A., Salta

Centro Polivalente de Asistencia e Inv. Clinica CER, San Juan

Centro Integral de Reumatologia, San Miguel de Tucumán

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

Investigaciones Clinicas Tucuman, San Miguel de Tucumán

CPD - Centro de Pesquisas em Diabetes, Porto Alegre

CLION - Clínica de Oncologia da Bahia, Salvador

Clínica de Neoplasias Litoral Ltda., Santa Catarina

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto

"MHAT Eurohospital - Plovdiv, OOD", Plovdiv

"Medical Center Teodora, EOOD", Rousse

"DCC Sveta Anna, EOOD", Sofia

"UMHAT Sv. Ivan Rilski, EAD", Sofia

"Medical Center Nov Rehabilitatsionen Tsentar, EOOD", Stara Zagora

MHAT-Targovishte, AD, Targovishte

Biomedica, Santiago

Centro de Estudios Reumatologicos, Santiago

Centro Medico Prosalud, Santiago

SOMEAL, Santiago

CINVEC - Centro de Investigacion Clinica V Region, Viña del Mar

A-Shine, s.r.o., Pilsen

Revmatologicky Ustav, Prague

Vseobecna fakultni nemocnice v Praze, Prague

MEDICAL PLUS s.r.o., Uherské Hradiště

Kerckhoff-Klinik gGmbH, Bad Nauheim

Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin

Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt

Universitaetsklinikum Freiburg, Freiburg im Breisgau

Rheumazentrum Ruhrgebiet, Herne

Universitaetsklinikum Schleswig-Holstein - Campus Kiel, Kiel

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari, Bari

Presidio Ospedaliero Vittorio Emanuele, Catania

Azienda Ospedaliera Universitaria Careggi, Florence

Azienda Ospedaliero Universitaria San Martino, Genova

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Fondazione IRCCS Policlinico San Matteo, Pavia

St. Luke's International Hospital, Chūōku

NHO Kyushu Medical Center, Fukuoka

Toho University Ohashi Medical Center, Meguro-ku

Okayama University Hospital, Okayama

Kitasato University Hospital, Sagamihara-shi

Hokkaido University Hospital, Sapporo

Sapporo City General Hospital, Sapporo

Hakujujikai Sasebochuo Hospital, Sasebo-shi

Tohoku University Hospital, Sendai

Jichi Medical University Hospital, Shimotsuke-shi

National Center for Global Health and Medicine Hospital, Shinjuku

Yuaikai Tomishiro Chuo Hospital, Tomigusuku-shi

Tsukuba University Hospital, Tsukuba

Investigacion y Biomedicina de Chihuahua, S.C., Chihuahua City

Icle S.C., Guadalajara

Unidad de Investigacion en Enfermedades Cronico Degenerativas SC, Guadalajara

Investigacion Clinica de Leon S.C., León

Morales Vargas Centro de Investigacion, S.C., León

Centro de Estudios Clinicos Especializados, Mérida

Accelerium S. de R.L. de C.V., Monterrey

ALIVIA Clínica de Alta Especialidad S.A. de C.V., Monterrey

Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C., Morelia

"Hospital Universitario de Saltillo Dr. Gonzalo Valdés Valdés", Saltillo

Clinica El Golf, Lima

Clinica Medica Cayetano Heredia, Lima

Clinica Vesalio, Lima

HMA - Hospital Maria Auxiliadora, Lima

Angeles University Foundation Medical Center, Angeles City

Mary Mediatrix Medical Center, Batangas

Davao Doctors Hospital, Davao City

Iloilo Doctors Hospital, Iloilo City

St. Luke's Medical Center, Quezon City

Szpital Uniwersytecki nr 2 im.dr J. Biziela, Bydgoszcz

"Niepubliczny Zaklad Opieki Zdrowotnej Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z", Torun

Rheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw

Wojskowy Instytut Medyczny, Warsaw

SBEI HPE Altai State Medical University of MoH and SD, Barnaul

"SBHI of Kem. Regional Clinical Hospital for War Veterans", Kemerovo

First Moscow State Medical University n.a. I.M. Sechenov, Moscow

Municipal City Hospital #2, Omsk

Republican Hospital n.a. V.A. Baranov, Petrozavodsk

Clinical Rheumatology Hospital #25, Saint Petersburg

Out - patient Clinic # 107, Saint Petersburg

City Clinical Hospital #12, Saratov

Regional Clinical Hospital, Saratov

Regional Clinical Hospital, Vladimir

Yaroslavl State Medical University, Yaroslavl

Dr CE Spargo and Dr RB Bhorat, Cape Town

Naidoo, A, Durban

Winelands Medical Research Centre, Stellenbosch

Gachon University Gil Medical Center, Incheon

Konkuk University Medical Center, Seoul

Kyung Hee University Hospital, Seoul

Seoul National University Hospital, Seoul

Ajou University Hospital, Suwon

Hospital General Universitario Gregorio Marañon, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital de Sagunto, Sagunto

Hospital Clínico Universitario de Valladolid, Valladolid

Royal National Hospital for Rheumatic Diseases, Bath

Royal Sussex County Hospital, Brighton

University Hospital Coventry, Coventry

Guy's Hospital, London

University College London Hospitals, London

Wrightington Hospital, Wigan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT01972568 - Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus | Biotech Hunter | Biotech Hunter