Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Registration Number
- NCT01972568
- Lead Sponsor
- EMD Serono
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atacicept 75 mg Atacicept 75 milligram (mg) - Placebo Placebo - Atacicept 150 mg Atacicept 150 mg -
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline Week 24 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 Week 24 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
Name Time Method Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24 Screening and Week 24 Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.
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 Week 24 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 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.
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks) 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 From Randomization to First SRI Response During Treatment Period Baseline up to 24 Weeks 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 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.
Change From Week 0 (Day 1) in SF-36 Components at Week 24 Week 0 (Day 1) and 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.
Trial Locations
- Locations (137)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Atencion Integral en Reumatologia (AIR)
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Organizacion Medica de Investigacion (OMI)
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Cordis S.A.
🇦🇷Salta, Argentina
Hospital Italiano
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Centro Polivalente de Asistencia e Inv. Clinica CER
🇦🇷San Juan, Argentina
Investigaciones Clinicas Tucuman
🇦🇷San Miguel de Tucuman, Argentina
Centro Integral de Reumatologia
🇦🇷San Miguel de Tucumán, Argentina
Policlìnica Red Omip S.A - Ensayos Clinicos GC
🇦🇷Mar De Plata, Argentina
Centro de Investigacion Pergamino SA
🇦🇷Pergamino, Argentina
MHAT "Eurohospital" - Plovdiv, OOD
🇧🇬Plovdiv, Bulgaria
Medical Center "Teodora", EOOD
🇧🇬Ruse, Bulgaria
Biomedica
🇨🇱Santiago, Chile
DCC "Sveta Anna", EOOD
🇧🇬Sofia, Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
🇧🇬Stara Zagora, Bulgaria
National Center for Global Health and Medicine Hospital
🇯🇵Shinjuku, Japan
Investigacion y Biomedicina de Chihuahua, S.C.
🇲🇽Chihuahua, Mexico
Accelerium S. de R.L. de C.V.
🇲🇽Monterrey, Mexico
Tohoku University Hospital
🇯🇵Sendai-shi, Japan
Yuaikai Tomishiro Chuo Hospital
🇯🇵Tomigusuku-shi, Japan
Morales Vargas Centro de Investigacion, S.C.
🇲🇽Leon, Mexico
Clinica Vesalio
🇵🇪Lima, Peru
HMA - Hospital Maria Auxiliadora
🇵🇪Lima, Peru
Mary Mediatrix Medical Center
🇵ðŸ‡Batangas, Philippines
Southern California Permanente Medical Group
🇺🇸Anaheim, California, United States
Center for Rheumatology, Immunology & Arthritis
🇺🇸Fort Lauderdale, Florida, United States
The Feinstein Institute for Medical Research
🇺🇸Manhasset, New York, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
🇩🇪Berlin, Germany
ClÃnica de Neoplasias Litoral Ltda.
🇧🇷Santa Catarina, Brazil
Box Arthritis & Rheumatology of the Carolinas PLLC
🇺🇸Charlotte, North Carolina, United States
Clinical Research of West Florida - Corporate
🇺🇸Dunedin, Florida, United States
APRILLUS
🇦🇷Ciudad Autonoma Buenos aires, Argentina
UMHAT "Sv. Ivan Rilski", EAD
🇧🇬Sofia, Bulgaria
STAT Research, Inc.
🇺🇸Dayton, Ohio, United States
Danville Orthopedic Clinic, Inc.
🇺🇸Danville, Virginia, United States
Fundação Faculdade Regional de Medicina de São José do Rio Preto
🇧🇷São José do Rio Preto, Brazil
CPD - Centro de Pesquisas em Diabetes
🇧🇷Porto Alegre, Brazil
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
A-Shine, s.r.o.
🇨🇿Plzen, Czechia
Revmatologicky Ustav
🇨🇿Praha 2, Czechia
Rheumazentrum Ruhrgebiet
🇩🇪Herne, Germany
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Royal National Hospital for Rheumatic Diseases
🇬🇧Bath, United Kingdom
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
🇮🇹Bari, Italy
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
University Hospital Coventry
🇬🇧Coventry, United Kingdom
University College London Hospitals
🇬🇧London, United Kingdom
Wrightington Hospital
🇬🇧Wigan, United Kingdom
Hospital ClÃnico Universitario de Valladolid
🇪🇸Valladolid, Spain
East Bay Rheumatology Medical Group, Inc.
🇺🇸San Leandro, California, United States
Goldpoint Clinical Research, LLC
🇺🇸Indianapolis, Indiana, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Arthritis & Rheumatology Center of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
OMRF
🇺🇸Oklahoma City, Oklahoma, United States
University of Alabama at Birmingham - (UAB)
🇺🇸Birmingham, Alabama, United States
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon-si, Korea, Republic of
Wallace Rheumatic Study Center
🇺🇸Los Angeles, California, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
AA MRC LLC Ahmed Arif Medical Research Center
🇺🇸Grand Blanc, Michigan, United States
Clinical Research Center of Reading LLC
🇺🇸Wyomissing, Pennsylvania, United States
UTMB Pathology Clinical Services
🇺🇸Galveston, Texas, United States
Arthritis & Osteoporosis Clinic
🇺🇸Waco, Texas, United States
Tsukuba University Hospital
🇯🇵Tsukuba-shi, Japan
Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
🇲🇽Guadalajara, Mexico
Pinnacle Research Group LLC
🇺🇸Anniston, Alabama, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
North MS Medical Clinics, Inc.
🇺🇸Tupelo, Mississippi, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
MetroHealth System
🇺🇸Cleveland, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Centro Medico Privado de Reumatologia
🇦🇷San Miguel de Tucuman, Argentina
CLION - ClÃnica de Oncologia da Bahia
🇧🇷Salvador, Brazil
MHAT-Targovishte, AD
🇧🇬Targovishte, Bulgaria
Centro de Estudios Reumatologicos
🇨🇱Santiago, Chile
Centro Medico Prosalud
🇨🇱Santiago, Chile
SOMEAL
🇨🇱Santiago, Chile
CINVEC - Centro de Investigacion Clinica V Region
🇨🇱Vina del Mar, Chile
MEDICAL PLUS s.r.o.
🇨🇿Uherske Hradiste, Czechia
Kerckhoff-Klinik gGmbH
🇩🇪Bad Nauheim, Germany
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Presidio Ospedaliero Vittorio Emanuele
🇮🇹Catania, Italy
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
🇩🇪Kiel, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
🇩🇪Mainz, Germany
Azienda Ospedaliero Universitaria San Martino
🇮🇹Genova, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
St. Luke's International Hospital
🇯🇵Chuo-ku, Japan
NHO Kyushu Medical Center
🇯🇵Fukuoka-shi, Japan
Toho University Ohashi Medical Center
🇯🇵Meguro-ku, Japan
Okayama University Hospital
🇯🇵Okayama-shi, Japan
Kitasato University Hospital
🇯🇵Sagamihara-shi, Japan
Hokkaido University Hospital
🇯🇵Sapporo-shi, Japan
Sapporo City General Hospital
🇯🇵Sapporo-shi, Japan
Hakujujikai Sasebochuo Hospital
🇯🇵Sasebo-shi, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke-shi, Japan
Icle S.C.
🇲🇽Guadalajara, Mexico
Investigacion Clinica de Leon S.C.
🇲🇽Leon, Mexico
Centro de Estudios Clinicos Especializados
🇲🇽Merida, Mexico
Clinica de Enfermedades Cronicas y de Procedimientos Especiales, S.C.
🇲🇽Morelia, Mexico
Hospital Universitario de Saltillo "Dr. Gonzalo Valdés Valdés"
🇲🇽Saltillo, Mexico
ALIVIA ClÃnica de Alta Especialidad S.A. de C.V.
🇲🇽Monterrey, Mexico
Clinica El Golf
🇵🇪Lima, Peru
Clinica Medica Cayetano Heredia
🇵🇪Lima, Peru
Angeles University Foundation Medical Center
🇵ðŸ‡Angeles City, Philippines
Iloilo Doctors Hospital
🇵ðŸ‡Iloilo City, Philippines
Davao Doctors Hospital
🇵ðŸ‡Davao City, Philippines
St. Luke's Medical Center
🇵ðŸ‡Quezon City, Philippines
Szpital Uniwersytecki nr 2 im.dr J. Biziela
🇵🇱Bydgoszcz, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
🇵🇱Warsaw, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z
🇵🇱Torun, Poland
Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
SBEI HPE Altai State Medical University of MoH and SD
🇷🇺Barnaul, Russian Federation
SBHI of Kem. "Regional Clinical Hospital for War Veterans"
🇷🇺Kemerovo, Russian Federation
Municipal City Hospital #2
🇷🇺Omsk, Russian Federation
First Moscow State Medical University n.a. I.M. Sechenov
🇷🇺Moscow, Russian Federation
Republican Hospital n.a. V.A. Baranov
🇷🇺Petrozavodsk, Russian Federation
Regional Clinical Hospital
🇷🇺Vladimir, Russian Federation
City Clinical Hospital #12
🇷🇺Saratov, Russian Federation
Clinical Rheumatology Hospital #25
🇷🇺St. Petersburg, Russian Federation
Out - patient Clinic # 107
🇷🇺St. Petersburg, Russian Federation
Yaroslavl State Medical University
🇷🇺Yaroslavl, Russian Federation
Dr CE Spargo and Dr RB Bhorat
🇿🇦Cape Town, South Africa
Naidoo, A
🇿🇦Durban, South Africa
Winelands Medical Research Centre
🇿🇦Stellenbosch, South Africa
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital de Sagunto
🇪🇸Sagunto, Spain
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Guy's Hospital
🇬🇧London, United Kingdom