Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
NCT ID: NCT02070978
Last Updated: 2019-03-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
253 participants
INTERVENTIONAL
2014-07-29
2018-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atacicept 75 mg
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.
Atacicept 150 mg
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.
Placebo/Atacicept 150 mg
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential who had a negative pregnancy test
Exclusion Criteria
* Diagnosis of any demyelinating disease, such as, but not restricted to, multiple sclerosis (MS) or optic neuritis
* Pregnancy
* Active clinically significant viral, bacterial, or fungal infection, or any major episode of infection that in the investigator's opinion makes the participants unsuitable to continued participation in the study
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
Locations
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Pinnacle Research Group LLC
Anniston, Alabama, United States
University of Alabama at Birmingham - (UAB)
Birmingham, Alabama, United States
Wallace Rheumatic Study Center
Beverly Hills, California, United States
Southern California Permenent Medical Group
Fontana, California, United States
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, United States
Clinical Research of West Florida - Corporate
Clearwater, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
McIlwain Medical Group, PA
Tampa, Florida, United States
AA MRC LLC Ahmed Arif Medical Research Center
Grand Blanc, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Clayton Medical Associates, P.C.
St Louis, Missouri, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
The Feinstein Institute for Medical Research
Manhasset, New York, United States
Hospital for Special Surgery
New York, New York, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
MetroHealth System
Cleveland, Ohio, United States
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, United States
OMRF
Oklahoma City, Oklahoma, United States
Clinical Research Center of Reading LLC
Wyomissing, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Austin Regional Clinic, P.A.
Austin, Texas, United States
Little River Arthritis & Osteoporosis Clinic
Waco, Texas, United States
Instituto CAICI
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Integral de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Investigaciones Clinicas Tucuman
San Miguel de Tucumán, Tucumán Province, Argentina
Organizacion Medica de Investigacion (OMI)
Ciudad Autonoma Buenos Aires, , Argentina
APRILLUS
Ciudad Autonoma Buenos Aires, , Argentina
Atencion Integral en Reumatologia (AIR)
Ciudad Autonoma Buenos Aires, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
Cordis S.A.
Salta, , Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER
San Juan, , Argentina
Centro de Pesquisas em Diabetes Ltda.
Porto Alegre, Rio Grande do Sul, Brazil
MHAT "Eurohospital" - Plovdiv, OOD
Plovdiv, , Bulgaria
Medical Center "Teodora", EOOD
Rousse, , Bulgaria
MHAT - Ruse, AD
Rousse, , Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, , Bulgaria
DCC "Sveta Anna", EOOD
Sofia, , Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, , Bulgaria
MHAT-Targovishte, AD
Targovishte, , Bulgaria
Corporacion de Beneficencia Osorno
Osorno, , Chile
Quantum Research Santiago
Puerto Varas, , Chile
Centro Medico Prosalud
Santiago, , Chile
Biomedica
Santiago, , Chile
Centro de Estudios Reumatologicos
Santiago, , Chile
CINVEC - Centro de Investigacion Clinica V Region
Viña del Mar, , Chile
Revmatologicky Ustav
Prague, , Czechia
Revmatologicka ambulance
Uherské Hradiště, , Czechia
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, Rhineland-Palatinate, Germany
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, , Germany
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Hospital Universitario de Saltillo "Dr. Gonzalo Valdés Valdés"
Saltillo, Coahuila, Mexico
Morales Vargas Centro de Investigacion, S.C.
León, Guanajuato, Mexico
Icle S.C.
Guadalajara, Jalisco, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
Guadalajara, Jalisco, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico City, Mexico
Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.
Morelia, Michoacán, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, Nuevo León, Mexico
Centro Multidisciplinario para el desarrollo Especializado de la Investigacion Clinica en Yucatan
Mérida, Yucatán, Mexico
Investigacion y Biomedicina de Chihuahua, S.C.
Chihuahua City, , Mexico
Hogar Clínica San Juan de Dios - Arequipa
Arequipa, , Peru
Clinica Medica Cayetano Heredia
Lima, , Peru
Invest Clinicas Sac Inst de Ginecologia y Reproduccion
Lima, , Peru
Angeles University Foundation Medical Center
Angeles City, Pampanga, , Philippines
Mary Mediatrix Medical Center
Batangas, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
Iloilo Doctors Hospital
Iloilo City, , Philippines
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, , Poland
FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
Moscow, , Russia
SBIH of Republic Kareliya "Republican Hospital n.a. V.A. Baranov"
Petrozavodsk, , Russia
SPb SBIH "Clinical Rheumatological Hospital # 25"
Saint Petersburg, , Russia
SIH "Saratov City Clinical Hospital # 12"
Saratov, , Russia
SBIH of Vladimir region "Regional Clinical Hospital"
Vladimir, , Russia
SBHI of Yaroslavl Region "Clinical Hospital # 8"
Yaroslavl, , Russia
Naidoo, A
Durban, KwaZulu-Natal, South Africa
Winelands Medical Research Centre
Stellenbosch, Western Cape, South Africa
Seoul National University Hospital
Seoul, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Konkuk University Medical Center
Seoul, , South Korea
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Queen's Hospital
Romford, Essex, United Kingdom
University College London Hospitals
London, Greater London, United Kingdom
Guy's Hospital
London, Greater London, United Kingdom
Countries
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References
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Wallace DJ, Isenberg DA, Morand EF, Vazquez-Mateo C, Kao AH, Aydemir A, Pudota K, Ona V, Aranow C, Merrill JT. Safety and clinical activity of atacicept in the long-term extension of the phase 2b ADDRESS II study in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Nov 3;60(11):5379-5389. doi: 10.1093/rheumatology/keab115.
Other Identifiers
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2013-002758-62
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
700461-024
Identifier Type: -
Identifier Source: org_study_id
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