Clinical trial NCT02975336: A Phase II Study of M2951 in SLE
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
M2951
Placebo
Dose response
Oral Corticosteroids
Safety
Efficacy
Autoimmune And Inflammatory Disorders
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2016-11-29
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).


Eligibility criteria: Inclusion Criteria:

* Eligible male and female participants, aged 18 to 75 years
* Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
* SLEDAI-2K total score greater than or equal to (\>=) 6 (including clinical SLEDAI greater than or equal to (\>=) 4) at Screening Visit
* And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (\>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
* Proteinuria (urine protein to creatinine ratio \[UPCR\] \> 4 mg/mg)
* Acutely worsened renal function
* Central nervous system SLE
* Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 30 mg daily prednisone equivalent
* Use of injectable corticosteroids, or change in dose of corticosteroids.
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52
timeFrame: Week 52
measure: DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52
timeFrame: Week 52
measure: DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
timeFrame: Baseline up to Week 56
measure: DBPC Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity According to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
timeFrame: Baseline up to Week 56
measure: DBPC Period: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to Week 56
measure: DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Week 56
measure: DBPC Period: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters
timeFrame: Baseline up to Week 56
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2
timeFrame: Week 2
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4
timeFrame: Week 4
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12
timeFrame: Week 12
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24
timeFrame: Week 24
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36
timeFrame: Week 36
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52
timeFrame: Week 52
measure: DBPC Period: Mean Absolute Value of Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56
timeFrame: Week 56
measure: DBPC Period: Mean Absolute Total B Cell Count at Week 4
timeFrame: Week 4
measure: DBPC Period: Mean Absolute Total B Cell Count at Week 24
timeFrame: Week 24
measure: DBPC Period: Mean Absolute Total B Cell Count at Week 52
timeFrame: Week 52
measure: DBPC Period: Mean Absolute Total B Cell Count at Week 56
timeFrame: Week 56
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 2
timeFrame: Baseline and Week 2
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 4
timeFrame: Baseline and Week 4
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 12
timeFrame: Baseline and Week 12
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 24
timeFrame: Baseline and Week 24
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 36
timeFrame: Baseline and Week 36
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 52
timeFrame: Baseline and Week 52
measure: DBPC Period: Change From Baseline in Serum Immunoglobulin (Ig) Levels (IgG, IgA, IgM) at Week 56
timeFrame: Baseline and Week 56
measure: DBPC Period: Change From Baseline in Total B Cell Count at Week 4
timeFrame: Baseline and Week 4
measure: DBPC Period: Change From Baseline in Total B Cell Count at Week 24
timeFrame: Baseline and Week 24
measure: DBPC Period: Change From Baseline in Total B Cell Count at Week 52
timeFrame: Baseline and Week 52
measure: DBPC Period: Change From Baseline in Total B Cell Count at Week 56
timeFrame: Baseline and Week 56
Secondary outcomes:
measure: DBPC Period: Time to First Severe British Isles Lupus Assessment Group (BILAG) A Flare
timeFrame: Baseline up to Week 56
measure: DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52 in Serologically Active (SA) Subgroup
timeFrame: Week 52
measure: DBPC Period: Number of Participants With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52 in Serologically Active Subgroup
timeFrame: Week 52
measure: DBPC Period: Time to First British Isles Lupus Assessment Group (BILAG) A or 2B Moderate to Severe Flare
timeFrame: Baseline up to Week 56
measure: DBPC Period: Number of Participants With British Isles Lupus Assessment Group (BILAG) 2004 Flare-Free Status During the 52-Week Treatment Period
timeFrame: up to Week 52
measure: DBPC Period: Annualized Flare Rate
timeFrame: Baseline up to Week 52
measure: DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52
timeFrame: Week 52
measure: DBPC Period: Number of Participants With Low Disease Activity Status, Defined by Clinical Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score of Less Than or Equal (<= ) 2 at Week 52
timeFrame: Week 52
measure: DBPC Period: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: DBPC Period: Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: DBPC Period: Number of Participants With Response Based on BILAG-Based Composite Lupus Assessment (BICLA) at Week 52
timeFrame: Week 52
measure: DBPC Period: Change From Baseline in British Isles Lupus Assessment Group (BILAG)-2004 Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: DBPC Period: Change From Baseline in Physician's Global Assessment (PGA) Score at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: DBPC Period: Change From Baseline in Study 36-Item Short Form Health Survey Version 2 (SF-36v2) Physical Component Summary Score and Mental Component Summary Scores at Week 4, 8, 12, 16, 24, 32, 40 and 52
timeFrame: Baseline, Week 4, 8, 12, 16, 24, 32, 40 and 52
measure: DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire at Week 4, 8, 12, 16, 24, 32, 40 and 52
timeFrame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52
measure: DBPC Period: Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Visual Analog Scale (VAS) at Week 4, 8, 12, 16, 24, 32, 40 and 52
timeFrame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52
measure: DBPC Period: Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score at Week 4, 8, 12, 16, 24, 32, 40 and 52
timeFrame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52
measure: DBPC Period: Number of Participants With Patient Global Impression of Change (PGIC) Scale Score of Any Improvement, no Change and Any Worsening
timeFrame: Week 4, 8, 12, 16, 24, 32, 40, and 52
measure: DBPC Period: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 4, 8, 12, 16, 24, 32, 40 and 52
timeFrame: Baseline, Week 4, 8, 12, 16, 24, 32, 40, and 52
measure: DBPC Period: Number of Participants With Change From Baseline in Prednisone Equivalent Corticosteroid (CS) Dose by >=25% to a Dose of <=7.5 Milligram Per Day (mg/Day), With no BILAG A or 2B Flare in Disease Activity at Week 52
timeFrame: Baseline and Week 52
measure: DBPC Period: Change From Baseline to Week 52 in Prednisone Equivalent Corticosteroid (CS) Daily Dose at at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
measure: DBPC Period: Number of Participants With Reduction From Baseline in Prednisone Equivalent Corticosteroid (CS) Daily Dose by > 0 to 25%, >25% to 50%, >50% to 100% or an Increase at Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: DBPC Period: Cumulative Prednisone Equivalent Corticosteroid (CS) Dose at Week 52
timeFrame: Week 52
measure: DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 52
timeFrame: Week 52
measure: DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) at Week 52
timeFrame: Week 52
measure: DBPC Period: Number of Participants With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to 7.5 mg Prednisone Equivalent Per Day or Less With Response Based on SRI-4 at Week 52 in Serologically Active Subgroup
timeFrame: Week 52
measure: DBPC Period: Number of Participants With Lupus Low Disease Activity State (LLDAS) at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group LLC
state: Alabama
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Beverly Hills
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Fontana
country: United States
facility: Southern California Permanent Medical Group
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group, Inc.
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: West Hills
country: United States
facility: Nazanin Firooz, MD Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Denver Anschutz Medical Campus
state: Colorado
city: New Haven
country: United States
facility: Yale School Of Medicine
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida - Corporate
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology, Immunology & Arthritis
state: Florida
city: Miami
country: United States
facility: Hope Clinical Trials
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development
state: Florida
city: Tampa
country: United States
facility: McIlwain Medical Group, PA
state: Florida
city: Tampa
country: United States
facility: Meridien Research, Inc.
state: Florida
city: Marietta
country: United States
facility: Marietta Rheumatology Associates, PC
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: Shreveport
country: United States
facility: LSU Health Sciences Center Gastroenterology
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: AA MRC LLC Ahmed Arif Medical Research Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center PRIME
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Innovative Clinical Research, LLC
state: South Carolina
city: Dallas
country: United States
facility: Metroplex Clinical Research Center, LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management - Brionez
state: Texas
city: Pearland
country: United States
facility: Medical Center Research, LLC Webster Office
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Seattle
country: United States
facility: FSAEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
state: Washington
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Investigaciones Clinicas Tucuman
state: Tucuman
city: San Miguel de Tucumán
country: Argentina
facility: Centro Integral de Reumatologia
state: Tucuman
city: Ciudad Autonoma Buenos aires
country: Argentina
facility: APRILLUS
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Clinica Adventista Belgrano
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital General de Agudos Dr. J. M. Ramos Mejia
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Mendoza
country: Argentina
facility: Instituto de Reumatologia
city: Salta
country: Argentina
facility: Cordis S.A.
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Inv. Clinica CER
city: Plovdiv
country: Bulgaria
facility: UMHAT "Pulmed" OOD
city: Ruse
country: Bulgaria
facility: MHAT - Ruse, AD
city: Sevlievo
country: Bulgaria
facility: Medizinski Zentar-1-Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: Medical Center "Excelsior", OOD
city: Sofia
country: Bulgaria
facility: Medical Center Comac Medical EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "SofiaMed", OOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Osorno
country: Chile
facility: Corporacion de Beneficencia Osorno
city: Santiago
country: Chile
facility: Centro de Estudios Reumatologicos
city: Santiago
country: Chile
facility: Centro Medico Prosalud
city: Santiago
country: Chile
facility: Interin
city: Santiago
country: Chile
facility: Psicomedica Clinical and Research Group
city: Santiago
country: Chile
facility: Quantum Research Santiago
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y Ortopedia SAS
city: Barranquilla
country: Colombia
facility: Clínica de la Costa Ltda.
city: Bogota
country: Colombia
facility: Fundacion Instituto de Reumatologia Fernando Chalem
city: Bogotá
country: Colombia
facility: Simedics Ips Sas
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S.
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milano
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Toon-shi
country: Japan
facility: Ehime University Hospital
state: Ehime-Ken
city: Kitakyushu-shi
country: Japan
facility: Tobata General Hospital
state: Fukuoka-Ken
city: Kitakyushu-shi
country: Japan
facility: University of Occupational and Environmental Health Hospital
state: Fukuoka-Ken
city: Asahikawa-shi
country: Japan
facility: NHO Asahikawa Medical Center
state: Hokkaido
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa-Ken
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa-Ken
city: Kagoshima-shi
country: Japan
facility: Eiraku Clinic
state: Kagoshima-Ken
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi-Ken
city: Hamamatsu-shi
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka-Ken
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi-Ken
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo-To
city: Fuchu-shi
country: Japan
facility: Tokyo Metropolitan Tama Medical Center
state: Tokyo-To
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo-To
city: Yonago-shi
country: Japan
facility: Tottori University Hospital
state: Tottori-Ken
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Muar
country: Malaysia
facility: Hospital Pakar Sultanah Fatimah
state: Johor
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
state: Selangor
city: Bukit Jalil
country: Malaysia
facility: International Medical University (IMU) Healthcare
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Solferino-Phoenix
country: Mauritius
facility: CAP Research
city: Cuauhtemoc
country: Mexico
facility: Unidad de Investigacion de las Enfermedades Reumaticas
state: Distrito Federal
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
state: Distrito Federal
city: Tlalnepantla
country: Mexico
facility: Clinical Research Institute S.C.
state: Estado De Mexico
city: Leon
country: Mexico
facility: Morales Vargas Centro de Investigacion, S.C.
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion en Enfermedades Cronico Degenerativas SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
state: Nuevo León
city: San Luis Potosi
country: Mexico
facility: Hospital Central Dr Ignacio Morones Prieto
state: San Luis Potos
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua, S.C.
city: Arequipa
country: Peru
facility: Hogar Clínica San Juan de Dios - Arequipa
city: Lima
country: Peru
facility: Clinica El Golf
city: Lima
country: Peru
facility: Clinica Medica Cayetano Heredia
city: Lima
country: Peru
facility: Clinica San Juan Bautista
city: Lima
country: Peru
facility: Clinica Vesalio
city: Lima
country: Peru
facility: GINOBS SA. Instituto de Ginecologia y Reproduccion
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Lima
country: Peru
facility: University of Washington Medical Center
city: Miraflores
country: Peru
facility: ICCV Research Instituto del Cerebro y la Columna Vertebral
city: Angeles City, Pampanga
country: Philippines
facility: Angeles University Foundation Medical Center
city: Batangas
country: Philippines
facility: Mary Mediatrix Medical Center
city: Dasmariñas City, Cavite
country: Philippines
facility: De La Salle University Medical Center
city: Davao City
country: Philippines
facility: Davao Doctors Hospital
city: Davao City
country: Philippines
facility: Southern Philippines Medical Center
city: Iloilo City
country: Philippines
facility: Iloilo Doctors Hospital
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Bialystok
country: Poland
facility: CERMED
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela
city: Elblag
country: Poland
facility: Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek. Barbara Bazela
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: Nzoz Atopia
city: Warsawa
country: Poland
facility: Rheuma Medicus Zaklad
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Dr.I. Cantacuzino"
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Sf. Maria"
city: Tirgu Mures
country: Romania
facility: S.C Mediab S.R.L
city: Izhevsk
country: Russian Federation
facility: LLC "Alliance Biomedical - Ural Group"
city: Krasnoyarsk
country: Russian Federation
facility: TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich
city: Moscow
country: Russian Federation
facility: HMA - Hospital Maria Auxiliadora
city: Omsk
country: Russian Federation
facility: Ultramed
city: Saint-Petersburg
country: Russian Federation
facility: LLC Medical Sanitary Unit#157
city: Saint-Petersburg
country: Russian Federation
facility: SPb SBIH "Clinical Rheumatological Hospital # 25"
city: Saratov
country: Russian Federation
facility: SIH "Saratov City Clinical Hospital # 12"
city: St. Petersburg
country: Russian Federation
facility: Research Institute of Emergency Medical Care
city: Tomsk
country: Russian Federation
facility: Nebbiolo LLC
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre
state: Western Cape
city: Durban
country: South Africa
facility: Naidoo, A - Netcare Umhlanga Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.