Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)

PHASE2TerminatedINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

July 29, 2014

Primary Completion Date

April 5, 2016

Study Completion Date

February 9, 2018

Conditions
Lupus Erythematosus, Systemic
Interventions
DRUG

Atacicept 75 mg

Participants who received atacicept 75 milligram (mg) as once-weekly subcutaneous injection in the core study ADDRESS II continued to receive this dose during this LTE study. Participants in this reporting arm received the medication up to a maximum of 143.7 weeks.

DRUG

Atacicept 150 mg

Participants who received placebo in the core study ADDRESS II switched to receive atacicept 150 mg as once-weekly subcutaneous injection for up to a maximum of 97.7 weeks during this LTE study.

DRUG

Atacicept 150 mg

Participants who received atacicept 150 mg in core study ADDRESS II continued to receive atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Trial Locations (84)

1431

"UMHAT Sv. Ivan Rilski, EAD", Sofia

1750

"DCC Sveta Anna, EOOD", Sofia

2009

Angeles University Foundation Medical Center, Angeles City, Pampanga

4002

"MHAT Eurohospital - Plovdiv, OOD", Plovdiv

4127

Mary Mediatrix Medical Center, Batangas

4319

Naidoo, A, Durban

5000

Iloilo Doctors Hospital, Iloilo City

5400

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

6000

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

7000

"Medical Center Teodora, EOOD", Rousse

7002

MHAT - Ruse, AD, Rousse

7600

Winelands Medical Research Centre, Stellenbosch

7700

MHAT-Targovishte, AD, Targovishte

8000

Davao Doctors Hospital, Davao City

10021

Hospital for Special Surgery, New York

11031

The Feinstein Institute for Medical Research, Manhasset

13353

Charite Universitaetsmedizin Berlin - Campus Charite Mitte, Berlin

16499

Ajou University Hospital, Suwon

19610

Clinical Research Center of Reading LLC, Wyomissing

20122

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan

25000

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

28210

DJL Clinical Research, PLLC, Charlotte

29425

Medical University of South Carolina (MUSC), Charleston

31000

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

33603

Clinical Research of West Florida, Inc., Tampa

33613

McIlwain Medical Group, PA, Tampa

33765

Clinical Research of West Florida - Corporate, Clearwater

35294

University of Alabama at Birmingham - (UAB), Birmingham

36207

Pinnacle Research Group LLC, Anniston

37000

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

44109

MetroHealth System, Cleveland

44600

Icle S.C., Guadalajara

44620

Unidad de Investigacion en Enfermedades Cronico Degenerativas SC, Guadalajara

47005

Hospital Clinico Universitario de Valladolid, Valladolid

48439

AA MRC LLC Ahmed Arif Medical Research Center, Grand Blanc

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

55905

Mayo Clinic, Rochester

58249

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

63110

Washington University, St Louis

63117

Clayton Medical Associates, P.C., St Louis

64000

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

73103

Arthritis & Rheumatology Center of Oklahoma, Oklahoma City

73104

OMRF, Oklahoma City

76708

Little River Arthritis & Osteoporosis Clinic, Waco

78731

Austin Regional Clinic, P.A., Austin

90211

Wallace Rheumatic Study Center, Beverly Hills

92335

Southern California Permenent Medical Group, Fontana

94578

East Bay Rheumatology Medical Group, Inc., San Leandro

97130

Centro Multidisciplinario para el desarrollo Especializado de la Investigacion Clinica en Yucatan, Mérida

110744

Seoul National University Hospital, Seoul

119992

"FSBEI HE First Moscow State Medical University n.a. I.M. Sechenov of the MoH of the RF", Moscow

150003

"SBHI of Yaroslavl Region Clinical Hospital # 8", Yaroslavl

185019

"SBIH of Republic Kareliya Republican Hospital n.a. V.A. Baranov", Petrozavodsk

190068

"SPb SBIH Clinical Rheumatological Hospital # 25", Saint Petersburg

410039

"SIH Saratov City Clinical Hospital # 12", Saratov

600023

"SBIH of Vladimir region Regional Clinical Hospital", Vladimir

5290000

Corporacion de Beneficencia Osorno, Osorno

5550170

Quantum Research Santiago, Puerto Varas

7500000

Centro Medico Prosalud, Santiago

7500710

Biomedica, Santiago

7501126

Centro de Estudios Reumatologicos, Santiago

07103

Rutgers New Jersey Medical School, Newark

S2000PBJ

Instituto CAICI, Rosario

T4000AXL

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

T4000DVB

Centro Integral de Reumatologia, San Miguel de Tucumán

T4000ICL

Investigaciones Clinicas Tucuman, San Miguel de Tucumán

C1015ABO

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

C1046AAQ

APRILLUS, Ciudad Autonoma Buenos Aires

C1426AAL

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

X5016KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

A4400ANW

Cordis S.A., Salta

90035-170

Centro de Pesquisas em Diabetes Ltda., Porto Alegre

Unknown

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

128 50

Revmatologicky Ustav, Prague

686 01

Revmatologicka ambulance, Uherské Hradiště

06700

Clinstile, S.A. de C.V., Mexico City

00000

Hogar Clínica San Juan de Dios - Arequipa, Arequipa

Lima 31

Clinica Medica Cayetano Heredia, Lima

Lima 33

Invest Clinicas Sac Inst de Ginecologia y Reproduccion, Lima

85-168

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

05030

Konkuk University Medical Center, Seoul

RM7 0AG

Queen's Hospital, Romford

NW1 2PG

University College London Hospitals, London

SE1 7EH

Guy's Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT02070978 - Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II) | Biotech Hunter | Biotech Hunter