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Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus (ADDRESS II)

Primary Purpose

Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atacicept 75 milligram (mg)
Atacicept 150 mg
Placebo
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Atacicept, Placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible male and female subjects, aged 18 years or older
  • Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit
  • At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed >= 6 months prior to the screening visit)
  • Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Subjects have demyelinating disorder
  • Severe central nervous system SLE
  • Use of cyclophosphamide within 3 months of the screening visit
  • Urine protein:creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day
  • Other protocol defined exclusion criteria could apply

Sites / Locations

  • Pinnacle Research Group LLC
  • Achieve Clinical Research, LLC
  • University of Alabama at Birmingham - (UAB)
  • Southern California Permanente Medical Group
  • Wallace Rheumatic Study Center
  • East Bay Rheumatology Medical Group, Inc.
  • Clinical Research of West Florida - Corporate
  • Center for Rheumatology, Immunology & Arthritis
  • University of Miami Miller School of Medicine
  • Clinical Research of West Florida, Inc.
  • Goldpoint Clinical Research, LLC
  • AA MRC LLC Ahmed Arif Medical Research Center
  • Mayo Clinic
  • North MS Medical Clinics, Inc.
  • Washington University School of Medicine
  • Rutgers New Jersey Medical School
  • The Feinstein Institute for Medical Research
  • Hospital for Special Surgery
  • Box Arthritis & Rheumatology of the Carolinas PLLC
  • MetroHealth System
  • Ohio State University Medical Center
  • STAT Research, Inc.
  • Arthritis & Rheumatology Center of Oklahoma
  • OMRF
  • Lynn Health Science Institute
  • Clinical Research Center of Reading LLC
  • Medical University of South Carolina (MUSC)
  • UTMB Pathology Clinical Services
  • Arthritis & Osteoporosis Clinic
  • Danville Orthopedic Clinic, Inc.
  • APRILLUS
  • Atencion Integral en Reumatologia (AIR)
  • Hospital Italiano
  • Organizacion Medica de Investigacion (OMI)
  • Policlìnica Red Omip S.A - Ensayos Clinicos GC
  • Centro de Investigacion Pergamino SA
  • Cordis S.A.
  • Centro Polivalente de Asistencia e Inv. Clinica CER
  • Centro Medico Privado de Reumatologia
  • Investigaciones Clinicas Tucuman
  • Centro Integral de Reumatologia
  • CPD - Centro de Pesquisas em Diabetes
  • CLION - Clínica de Oncologia da Bahia
  • Clínica de Neoplasias Litoral Ltda.
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • MHAT "Eurohospital" - Plovdiv, OOD
  • Medical Center "Teodora", EOOD
  • DCC "Sveta Anna", EOOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • MHAT-Targovishte, AD
  • Biomedica
  • Centro de Estudios Reumatologicos
  • Centro Medico Prosalud
  • SOMEAL
  • CINVEC - Centro de Investigacion Clinica V Region
  • A-Shine, s.r.o.
  • Revmatologicky Ustav
  • Vseobecna fakultni nemocnice v Praze
  • MEDICAL PLUS s.r.o.
  • Kerckhoff-Klinik gGmbH
  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
  • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Universitaetsklinikum Freiburg
  • Rheumazentrum Ruhrgebiet
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
  • Presidio Ospedaliero Vittorio Emanuele
  • Azienda Ospedaliera Universitaria Careggi
  • Azienda Ospedaliero Universitaria San Martino
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Fondazione IRCCS Policlinico San Matteo
  • St. Luke's International Hospital
  • NHO Kyushu Medical Center
  • Toho University Ohashi Medical Center
  • Okayama University Hospital
  • Kitasato University Hospital
  • Hokkaido University Hospital
  • Sapporo City General Hospital
  • Hakujujikai Sasebochuo Hospital
  • Tohoku University Hospital
  • Jichi Medical University Hospital
  • National Center for Global Health and Medicine Hospital
  • Yuaikai Tomishiro Chuo Hospital
  • Tsukuba University Hospital
  • Gachon University Gil Medical Center
  • Konkuk University Medical Center
  • Kyung Hee University Hospital
  • Seoul National University Hospital
  • Ajou University Hospital
  • Investigacion y Biomedicina de Chihuahua, S.C.
  • Icle S.C.
  • Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
  • Investigacion Clinica de Leon S.C.
  • Morales Vargas Centro de Investigacion, S.C.
  • Centro de Estudios Clinicos Especializados
  • Accelerium S. de R.L. de C.V.
  • ALIVIA Clínica de Alta Especialidad S.A. de C.V.
  • Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.
  • Hospital Universitario de Saltillo "Dr. Gonzalo Valdés Valdés"
  • Clinica El Golf
  • Clinica Medica Cayetano Heredia
  • Clinica Vesalio
  • HMA - Hospital Maria Auxiliadora
  • Angeles University Foundation Medical Center
  • Mary Mediatrix Medical Center
  • Davao Doctors Hospital
  • Iloilo Doctors Hospital
  • St. Luke's Medical Center
  • Szpital Uniwersytecki nr 2 im.dr J. Biziela
  • Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
  • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Wojskowy Instytut Medyczny
  • SBEI HPE Altai State Medical University of MoH and SD
  • SBHI of Kem. "Regional Clinical Hospital for War Veterans"
  • First Moscow State Medical University n.a. I.M. Sechenov
  • Municipal City Hospital #2
  • Republican Hospital n.a. V.A. Baranov
  • City Clinical Hospital #12
  • Regional Clinical Hospital
  • Clinical Rheumatology Hospital #25
  • Out - patient Clinic # 107
  • Regional Clinical Hospital
  • Yaroslavl State Medical University
  • Dr CE Spargo and Dr RB Bhorat
  • Naidoo, A
  • Winelands Medical Research Centre
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario 12 de Octubre
  • Hospital de Sagunto
  • Hospital Clínico Universitario de Valladolid
  • Royal National Hospital for Rheumatic Diseases
  • Royal Sussex County Hospital
  • University Hospital Coventry
  • Guy's Hospital
  • University College London Hospitals
  • Wrightington Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Atacicept 75 mg

Atacicept 150 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.

Secondary Outcome Measures

Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity
BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone >20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.
Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24
The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.
Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24
Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.
Time From Randomization to First SRI Response During Treatment Period
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.
Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24
The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and <=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by <10% (defined as <0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
Change From Week 0 (Day 1) in SF-36 Components at Week 24
The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.

Full Information

First Posted
October 24, 2013
Last Updated
December 4, 2017
Sponsor
EMD Serono
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1. Study Identification

Unique Protocol Identification Number
NCT01972568
Brief Title
Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
Acronym
ADDRESS II
Official Title
A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono

4. Oversight

5. Study Description

Brief Summary
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Atacicept, Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atacicept 75 mg
Arm Type
Experimental
Arm Title
Atacicept 150 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atacicept 75 milligram (mg)
Intervention Description
Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Atacicept 150 mg
Intervention Description
Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.
Primary Outcome Measure Information:
Title
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline
Description
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.
Time Frame
Week 24
Title
Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline
Description
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity
Description
BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone >20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.
Time Frame
Week 24
Title
Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24
Description
The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.
Time Frame
Week 24
Title
Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24
Description
Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.
Time Frame
Screening and Week 24
Title
Time From Randomization to First SRI Response During Treatment Period
Description
SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.
Time Frame
Baseline up to 24 Weeks
Title
Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24
Description
The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and <=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by <10% (defined as <0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.
Time Frame
Week 24
Title
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Description
An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.
Time Frame
Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)
Title
Change From Week 0 (Day 1) in SF-36 Components at Week 24
Description
The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.
Time Frame
Week 0 (Day 1) and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible male and female subjects, aged 18 years or older Must have at least moderately active SLE, as defined as SLE Disease Activity Index-2000 (SLEDAI-2K) score greater than or equal to [>=] 6 at screening visit At least 4 of the 11 American college of rheumatology (ACR) classification criteria for SLE (diagnosed >= 6 months prior to the screening visit) Be seropositive for anti-nuclear antibodies (ANA) and/or anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibodies Other protocol defined inclusion criteria could apply Exclusion Criteria: Subjects have demyelinating disorder Severe central nervous system SLE Use of cyclophosphamide within 3 months of the screening visit Urine protein:creatinine ratio (UPCr) >= 2 milligram per milligram (mg/mg) per day Other protocol defined exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
University of Alabama at Birmingham - (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
East Bay Rheumatology Medical Group, Inc.
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Clinical Research of West Florida - Corporate
City
Dunedin
State/Province
Florida
ZIP/Postal Code
34698
Country
United States
Facility Name
Center for Rheumatology, Immunology & Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Goldpoint Clinical Research, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
AA MRC LLC Ahmed Arif Medical Research Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
North MS Medical Clinics, Inc.
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11031
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Box Arthritis & Rheumatology of the Carolinas PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
STAT Research, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Arthritis & Rheumatology Center of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
OMRF
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Clinical Research Center of Reading LLC
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
UTMB Pathology Clinical Services
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
Danville Orthopedic Clinic, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
APRILLUS
City
Ciudad Autonoma Buenos aires
Country
Argentina
Facility Name
Atencion Integral en Reumatologia (AIR)
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
Hospital Italiano
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
Organizacion Medica de Investigacion (OMI)
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
Policlìnica Red Omip S.A - Ensayos Clinicos GC
City
Mar De Plata
Country
Argentina
Facility Name
Centro de Investigacion Pergamino SA
City
Pergamino
Country
Argentina
Facility Name
Cordis S.A.
City
Salta
Country
Argentina
Facility Name
Centro Polivalente de Asistencia e Inv. Clinica CER
City
San Juan
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucuman
Country
Argentina
Facility Name
Investigaciones Clinicas Tucuman
City
San Miguel de Tucuman
Country
Argentina
Facility Name
Centro Integral de Reumatologia
City
San Miguel de Tucumán
Country
Argentina
Facility Name
CPD - Centro de Pesquisas em Diabetes
City
Porto Alegre
Country
Brazil
Facility Name
CLION - Clínica de Oncologia da Bahia
City
Salvador
Country
Brazil
Facility Name
Clínica de Neoplasias Litoral Ltda.
City
Santa Catarina
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José do Rio Preto
Country
Brazil
Facility Name
MHAT "Eurohospital" - Plovdiv, OOD
City
Plovdiv
Country
Bulgaria
Facility Name
Medical Center "Teodora", EOOD
City
Ruse
Country
Bulgaria
Facility Name
DCC "Sveta Anna", EOOD
City
Sofia
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
Country
Bulgaria
Facility Name
MHAT-Targovishte, AD
City
Targovishte
Country
Bulgaria
Facility Name
Biomedica
City
Santiago
Country
Chile
Facility Name
Centro de Estudios Reumatologicos
City
Santiago
Country
Chile
Facility Name
Centro Medico Prosalud
City
Santiago
Country
Chile
Facility Name
SOMEAL
City
Santiago
Country
Chile
Facility Name
CINVEC - Centro de Investigacion Clinica V Region
City
Vina del Mar
Country
Chile
Facility Name
A-Shine, s.r.o.
City
Plzen
Country
Czechia
Facility Name
Revmatologicky Ustav
City
Praha 2
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
Country
Czechia
Facility Name
MEDICAL PLUS s.r.o.
City
Uherske Hradiste
Country
Czechia
Facility Name
Kerckhoff-Klinik gGmbH
City
Bad Nauheim
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universitaet
City
Frankfurt
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
City
Kiel
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
Country
Germany
Facility Name
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
City
Bari
Country
Italy
Facility Name
Presidio Ospedaliero Vittorio Emanuele
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
St. Luke's International Hospital
City
Chuo-ku
Country
Japan
Facility Name
NHO Kyushu Medical Center
City
Fukuoka-shi
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Meguro-ku
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-shi
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara-shi
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
Country
Japan
Facility Name
Sapporo City General Hospital
City
Sapporo-shi
Country
Japan
Facility Name
Hakujujikai Sasebochuo Hospital
City
Sasebo-shi
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke-shi
Country
Japan
Facility Name
National Center for Global Health and Medicine Hospital
City
Shinjuku
Country
Japan
Facility Name
Yuaikai Tomishiro Chuo Hospital
City
Tomigusuku-shi
Country
Japan
Facility Name
Tsukuba University Hospital
City
Tsukuba-shi
Country
Japan
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon-si
Country
Korea, Republic of
Facility Name
Investigacion y Biomedicina de Chihuahua, S.C.
City
Chihuahua
Country
Mexico
Facility Name
Icle S.C.
City
Guadalajara
Country
Mexico
Facility Name
Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
City
Guadalajara
Country
Mexico
Facility Name
Investigacion Clinica de Leon S.C.
City
Leon
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion, S.C.
City
Leon
Country
Mexico
Facility Name
Centro de Estudios Clinicos Especializados
City
Merida
Country
Mexico
Facility Name
Accelerium S. de R.L. de C.V.
City
Monterrey
Country
Mexico
Facility Name
ALIVIA Clínica de Alta Especialidad S.A. de C.V.
City
Monterrey
Country
Mexico
Facility Name
Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.
City
Morelia
Country
Mexico
Facility Name
Hospital Universitario de Saltillo "Dr. Gonzalo Valdés Valdés"
City
Saltillo
Country
Mexico
Facility Name
Clinica El Golf
City
Lima
Country
Peru
Facility Name
Clinica Medica Cayetano Heredia
City
Lima
Country
Peru
Facility Name
Clinica Vesalio
City
Lima
Country
Peru
Facility Name
HMA - Hospital Maria Auxiliadora
City
Lima
Country
Peru
Facility Name
Angeles University Foundation Medical Center
City
Angeles City
Country
Philippines
Facility Name
Mary Mediatrix Medical Center
City
Batangas
Country
Philippines
Facility Name
Davao Doctors Hospital
City
Davao City
Country
Philippines
Facility Name
Iloilo Doctors Hospital
City
Iloilo City
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
Country
Philippines
Facility Name
Szpital Uniwersytecki nr 2 im.dr J. Biziela
City
Bydgoszcz
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
City
Torun
Country
Poland
Facility Name
Rheuma Medicus Zaklad Opieki Zdrowotnej
City
Warsaw
Country
Poland
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
Country
Poland
Facility Name
SBEI HPE Altai State Medical University of MoH and SD
City
Barnaul
Country
Russian Federation
Facility Name
SBHI of Kem. "Regional Clinical Hospital for War Veterans"
City
Kemerovo
Country
Russian Federation
Facility Name
First Moscow State Medical University n.a. I.M. Sechenov
City
Moscow
Country
Russian Federation
Facility Name
Municipal City Hospital #2
City
Omsk
Country
Russian Federation
Facility Name
Republican Hospital n.a. V.A. Baranov
City
Petrozavodsk
Country
Russian Federation
Facility Name
City Clinical Hospital #12
City
Saratov
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Saratov
Country
Russian Federation
Facility Name
Clinical Rheumatology Hospital #25
City
St. Petersburg
Country
Russian Federation
Facility Name
Out - patient Clinic # 107
City
St. Petersburg
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Vladimir
Country
Russian Federation
Facility Name
Yaroslavl State Medical University
City
Yaroslavl
Country
Russian Federation
Facility Name
Dr CE Spargo and Dr RB Bhorat
City
Cape Town
Country
South Africa
Facility Name
Naidoo, A
City
Durban
Country
South Africa
Facility Name
Winelands Medical Research Centre
City
Stellenbosch
Country
South Africa
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital de Sagunto
City
Sagunto
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
Country
Spain
Facility Name
Royal National Hospital for Rheumatic Diseases
City
Bath
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
Country
United Kingdom
Facility Name
Wrightington Hospital
City
Wigan
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32107560
Citation
Morand EF, Isenberg DA, Wallace DJ, Kao AH, Vazquez-Mateo C, Chang P, Pudota K, Aranow C, Merrill JT. Attainment of treat-to-target endpoints in SLE patients with high disease activity in the atacicept phase 2b ADDRESS II study. Rheumatology (Oxford). 2020 Oct 1;59(10):2930-2938. doi: 10.1093/rheumatology/keaa029.
Results Reference
derived
PubMed Identifier
29073347
Citation
Merrill JT, Wallace DJ, Wax S, Kao A, Fraser PA, Chang P, Isenberg D; ADDRESS II Investigators. Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study. Arthritis Rheumatol. 2018 Feb;70(2):266-276. doi: 10.1002/art.40360. Erratum In: Arthritis Rheumatol. 2018 Mar;70(3):467. Arthritis Rheumatol. 2021 Nov;73(11):2043.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

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