Clinical trial NCT04680637: Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
Official title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Active Systemic Lupus Erythematosus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 168
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: The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.


Eligibility criteria: Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Participant is aged between 18 and 75.
* Fulfills classification criteria for systemic lupus erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening.
* Hybrid SLEDAI score ≥ 6 points with a "Clinical" hSLEDAI score ≥ 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results, including urine or immunologic parameters.
* British-Isles Lupus Assessment Group (BILAG) index score (BILAG 2004) of ≥ 1 A item or ≥ 2 B items.
* Must be taking ≥ 1 of the following SLE treatments (or regional equivalent): hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil, azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or OCS. A participant may enter the study on OCS alone (prednisone ≥ 10 mg/day or equivalent) only if the participant has previously documented trial of anti-malarial or immunosuppressant treatment for SLE. Participants must be on a stable dose for ≥ 8 weeks prior to screening for all antimalarials and immunosuppressants, with the exception of OCS doses which must be stable for ≥ 2 weeks prior to screening.
* For participants taking OCS, dose must be ≤ 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit and for ≥ 2 weeks prior to screening visit.
* Stability of SLE treatments: OCS and other immunosuppressants/immunomodulator agents and doses must be stable since screening visit.
* Disease activity: active disease as indicated by clinical hSLEDAI score ≥ 4 must be observed (clinical hSLEDAI score is the hSLEDAI assessment score without the inclusion of points attributable to laboratory results including urine and immunologic parameters).

Exclusion Criteria:

* Lupus nephritis if any of the following are present: urine protein creatinine ratio ≥ 2000 mg/g (or equivalent) at screening, OR requiring induction therapy currently or within 1 year prior to screening, OR histological evidence (if available) of diffuse proliferative glomerulonephritis within 12 weeks prior to screening.
* Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
* Currently present or within 1 year prior to screening a diagnosis of any chronic inflammatory disease other than SLE (eg, rheumatoid arthritis) which would interfere with SLE disease assessment.
* History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for \> 2 weeks within 4 months prior to screening.
* Active infection (including chronic or localized infections) for which anti-infectives are indicated currently or within 4 weeks prior to screening visit OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening visit.
* Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.
* Positive test for tuberculosis during creening defined as: either a positive or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD) (≥5 mm of induration at 48 to 72 hours after test is placed).
* Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb). A history of hepatitis B vaccination without history of hepatitis B infection (ie, positive hepatitis B surface antibody (HBsAb), negative HBsAg and negative HBcAb) is allowed.
* Positive for hepatitis C antibody.
* Known history of HIV or positive HIV test at screening.
* Presence of 1 or more significant concurrent medical conditions, including but not limited to the following:

  * poorly controlled diabetes (hemoglobin A1C \> 7) or hypertension
  * symptomatic heart failure (New York Heart Association class III or IV)
  * myocardial infarction or unstable angina pectoris within the past 12 months prior to screening
  * severe chronic pulmonary disease requiring oxygen therapy
  * multiple sclerosis or any other demyelinating disease
* Any history of malignancy with the following exceptions:
* resolved non-melanoma skin cancers \> 5 years prior to screening
* resolved cervical carcinoma \> 5 years prior to screening
* resolved breast ductal carcinoma in situ \> 5 years of screening
* Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent within 6 months prior to screening or sirolimus within 4 weeks prior screening.
* Currently receiving or had treatment with a Janus kinase (JAK) inhibitor within 3 months or less than 5 drug half-lives (whichever is longer) prior to screening.
* Currently receiving or had treatment with an immune checkpoint inhibitor (eg, programmed death 1 \[PD-1\] inhibitor, programmed death ligand 1 \[PD-L1\] inhibitor, cytotoxic T-lymphocyte associated protein 4 \[CTLA-4\] inhibitor).

Note: Abatacept is not considered a CTLA-4 inhibitor and is referred to below.

* Currently receiving or had treatment within 12 months prior to screening with T-cell depleting agents (eg, antithymocyte globulin, Campath).
* Currently receiving of had treatment with an interleukin 2 (IL-2) based therapy (eg, Proleukin).
* Current or previous treatment with a biologic agent with immunosuppressive/immunomodulatory activity as follows: rituximab within 6 months prior to screening; abatacept and belimumab within the past 3 months prior to screening; other biologics within \< 5 drug half lives prior to screening.
* Participants who have received intraarticular, intralesional, or intramuscular corticosteroids within 2 weeks prior to screening or intravenous corticosteroids within 6 weeks prior to screening.
* Participants who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines during the treatment period and up to 6 weeks after the end of treatment period in the study.
* Currently receiving treatment in another investigational device or drug study.
* Ending a treatment with an investigational drug or investigational device less than 3 months or 5 half-lives from the last dose of the investigational drug (whichever is longer) at screening.

Primary outcomes:
measure: Number of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Number of Participants Who Achieved a BILAG-based Composite Lupus Assessment (BICLA) Response at Week 52
timeFrame: Week 52
measure: Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) Response at Week 52
timeFrame: Week 52
measure: Number of Participants With a Reduction of Oral Corticosteroids (OCS) to ≤ 7.5 mg/Day by Week 44 and Sustained Through Week 52 in Participants With a Baseline OCS Dose ≥ 10 mg/Day
timeFrame: Baseline to Week 52
measure: Number of Participants Who Achieved a SRI-4 Response at Week 24
timeFrame: Week 24
measure: Number of Participants Who Achieved a BICLA Response at Week 24
timeFrame: Week 24
measure: Number of Participants With a hSLEDAI Response at Week 24 and Week 52
timeFrame: Week 24 and Week 52
measure: Number of Participants With an Improvement From Baseline in Tender and Swollen Joint Count ≥ 50% at Weeks 8, 12, 24, 36, and 52 in Participants With ≥ 6 Tender and Swollen Joints in Hands and Wrists
timeFrame: Weeks 8, 12, 24, 36 and 52
measure: Number of Participants With an Improvement From Baseline in Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Activity Score ≥ 50% at Week 8, 12, 24, 36, and 52 in Participants With a CLASI Activity Score ≥ 8 at Baseline
timeFrame: Weeks 8, 12, 24, 36 and 52
measure: Annualized Flare Rate Over 52 Weeks
timeFrame: Up to 52 weeks
measure: Change From Baseline in Fatigue Standardized Score Using the Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a Instrument at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Physical Component Score of the Medical Outcomes Short Form-36 Questionnaire Version 2 (SF-36V2) at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Mental Component Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Physical Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Social Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Physical Role Functioning Domain Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Bodily Pain Domain Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Mental Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Emotional Role Domain Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Vitality Domain Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the General Health Domain Score of the SF-36V2 at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Physical Health Domain Score of the Lupus Quality of Life (LupusQoL) at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Pain Domain Score of the LupusQoL at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Planning Domain Score of the LupusQoL at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Intimate Relationship Domain Score of the LupusQoL at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Burden to Others Domain Score of the LupusQoL at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Emotional Health Domain Score of the LupusQoL at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Body Image Domain Score of the LupusQoL at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Change From Baseline in the Fatigue Domain Score of the LupusQoL at Week 12, 24, 36 and 52
timeFrame: Baseline to Week 12, 24, 36 and 52
measure: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 to Week 56
measure: Serum Efavaleukin Alfa Concentrations by Timepoint
timeFrame: Day 1: 6-24 and 48-96 hrs, Day 29, Day 43: 6-24 and 48-96 hrs, Day 85, Day 169, Day 253, Day 309, and Day 365
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham,Arthritis Clinical Intervention Program
state: Alabama
city: Gilbert
country: United States
facility: Arizona Arthritis and Rheumatology Associates PC
state: Arizona
city: Glendale
country: United States
facility: Arizona Arthritis And Rheumatology Associates PC
state: Arizona
city: Tucson
country: United States
facility: Arizona Arthritis and Rheumatology Associates PC
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Health Care
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Tustin
country: United States
facility: Robin K Dore MD Inc
state: California
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Aventura
country: United States
facility: Life Clinical Trials
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology Immunology and Arthritis
state: Florida
city: Hollywood
country: United States
facility: GNP Research
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology and Immunology Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Medical Clinic
state: Florida
city: Tampa
country: United States
facility: Baycare Medical Group Inc
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Schaumburg
country: United States
facility: Greater Chicago Specialty Physicians
state: Illinois
city: Skokie
country: United States
facility: Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc
state: Illinois
city: Hopkinsville
country: United States
facility: Western Kentucky Rheumatology PLLC
state: Kentucky
city: Lake Charles
country: United States
facility: Accurate Clinical Research
state: Louisiana
city: Grand Blanc
country: United States
facility: Michigan Rheumatology Group, PC - Grand Blanc Office
state: Michigan
city: Lansing
country: United States
facility: Arthritis and Rheumatology of Michigan
state: Michigan
city: Bronx
country: United States
facility: Institute for Clinical and Translation Research at Einstein and Montefiore Clinical Research Center
state: New York
city: Brooklyn
country: United States
facility: New York University Langone Ambulatory Care Brooklyn Heights
state: New York
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Syracuse
country: United States
facility: State University of New York - Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill Thurston Arthritis Research Center
state: North Carolina
city: Charlotte
country: United States
facility: Joint and Muscle Research Institute
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research PLLC
state: North Carolina
city: Charlotte
country: United States
facility: Javara
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Rheumatology
state: North Carolina
city: Oklahoma City
country: United States
facility: Arthritis and Rheumatology Center of Oklahoma PLLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Lupus Center of Excellence
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Arthritis Center, PA
state: South Carolina
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute, LLC
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Ramesh C Gupta MD
state: Tennessee
city: Allen
country: United States
facility: Arthritis and Rheumatology Institute
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: El Paso
country: United States
facility: Texas Arthritis Center PA
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management
state: Texas
city: Houston
country: United States
facility: Laila A Hassan, MD, PA
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Associates, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio Medical Arts Research Clinic Marc
state: Texas
city: Waco
country: United States
facility: Arthritis and Osteoporosis Clinic
state: Texas
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Plovdiv
country: Bulgaria
facility: Diagnostic-Consultative Center Sveti Georgi EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: Medical Center Academy EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Providencia
country: Chile
facility: Investigacion y Terapias Reumatologicas Innovadoras LTDA - Interin LTDA
state: Santiago
city: Providencia
country: Chile
facility: Enroll SpA
state: Santiago
city: Providencia
country: Chile
facility: Sociedad de prestaciones Medicas y Paramedicas Goecke Gatica y Compania Limitada - Prosalud
state: Santiago
city: Osorno
country: Chile
facility: Corporacion de Beneficiencia Osorno
city: Santiago
country: Chile
facility: Estudios Clinicos Limitada - Centro de Estudios Reumatologicos
city: Santiago
country: Chile
facility: CECIM
city: Valdivia
country: Chile
facility: Sociedad de Prestaciones Medicas Intermedica Limitada
city: Viña del Mar
country: Chile
facility: Oncocentro Apys
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro Integral de Reumatología del Caribe Circaribe SAS
state: Atlántico
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas SAS
state: Cundinamarca
city: Bogota
country: Colombia
facility: Solano y Terront Servicios Medicos Ltda - Uniendo
state: Cundinamarca
city: Ibague
country: Colombia
facility: Mediservis del Tolima IPS SAS
state: Tolima
city: Santiago de Cali
country: Colombia
facility: Centro Medico Julian Coronel
state: Valle Del Cauca
city: Montpellier cedex 05
country: France
facility: Centre Hospitalier Universitaire de Montpellier Hopital Lapeyronie
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
city: Vandoeuvre Les Nancy Cedex
country: France
facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
city: Athens
country: Greece
facility: Athens Naval Hospital
city: Athens
country: Greece
facility: Laiko General Hospital
city: Athens
country: Greece
facility: Attiko Hospital
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Patra
country: Greece
facility: Olympion Hospital-General Clinic of Patras AE
city: Thessaloniki
country: Greece
facility: Euromedica - Kyanous Stavros
city: Thessaloniki
country: Greece
facility: Ippokrateio Hospital of Thessaloniki
city: New Territories
country: Hong Kong
facility: Tuen Mun Hospital
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Napoli
country: Italy
facility: Università degli studi della Campania Luigi Vanvitelli
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Umberto I
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria Integrata Santa Maria della Misericordia
city: Verona
country: Italy
facility: Centro Ricerche Cliniche
city: Nagoya-shi
country: Japan
facility: Japan Community Healthcare Organization Chukyo Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: National Hospital Organization Chibahigashi National Hospital
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health Japan
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kagoshima-shi
country: Japan
facility: Eiraku Clinic
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: St Marianna University Hospital
state: Kanagawa
city: Sendai-shi
country: Japan
facility: National University Corporation Tohoku University Tohoku University Hospital
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Hamamatsu-shi
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: St Lukes International Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic Universtiy Medcial Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Mexico City
country: Mexico
facility: CITER SA de CV (Centro de Investigación y Tratamiento de las Enfermedades Reumáticas SA de CV)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia SA de CV
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica, Sc
state: Jalisco
city: Monterrey
country: Mexico
facility: Eukarya Pharmasite sc
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Centro de Investigacion Integral Medivest SC
city: Cuautitlan Izcalli
country: Mexico
facility: Phylasis Clínicas Research S. De R. L. De C. V.
city: Bydgoszcz
country: Poland
facility: Centrum medyczne intercore sp zoo
city: Czestochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
city: Malbork
country: Poland
facility: Centrum Badan Klinicznych Wojciech Brzezicki
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED sc
city: Poznan
country: Poland
facility: Gabinety Lekarskie RIVERMED
city: Wroclaw
country: Poland
facility: Reumatop Grzegorz Rozumek, Karin Pistorius
city: Kazan
country: Russian Federation
facility: Limited liability company Scientific Research Medical Complex Your Health
city: Moscow
country: Russian Federation
facility: FSBSI SRI of Rheumatology na V A Nasonova
city: Moscow
country: Russian Federation
facility: I M Sechenov First Medical University of the MoH of RF
city: Saint Petersburg
country: Russian Federation
facility: LLC Medical Sanitary Unit №157
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budget Healthcare Institution Clinical Rheumatology Hospital 25
city: Yaroslavl
country: Russian Federation
facility: Center for medical consultations and research - practice
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
state: Andalucía
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Hospiten Rambla
state: Canarias
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluña
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: Galicia
city: Vitoria
country: Spain
facility: Hospital Universitario Araba
state: País Vasco
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital St Gallen
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Adana
country: Turkey
facility: Cukurova Universitesi Balcali Hastanesi Saglik Uygulama ve Arastirma Merkezi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: