A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Study Purpose

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematosus in adult patients with moderate to severe symptoms. The main questions it aims to answer are:

  • - How well cenerimod works on top of the treatment already being administered.
  • - How safe cenerimod is for adult patients with Systemic Lupus Erythematosus.
Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Inclusion criteria at screening:
  • - Signed Informed Consent Form (ICF) prior to any study-mandated procedure.
  • - Diagnosis of Systemic Lupus Erythematosus (SLE) made at least 6 months prior to Screening, according to 2019 European League Against Rheumatism / American College of Rheumatology Criteria.
  • - A modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score ≥ 6 and clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
The mSLEDAI-2K score does not include "leukopenia".
  • - British Isles Lupus Assessment Group-2004 (BILAG) Grade B in ≥ 2 organ systems or a BILAG Grade A in ≥ 1 organ system.
  • - Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 visual analog scale.
  • - Currently treated with one or more of the following SLE background medications: - Anti-malarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine).
  • - Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤1.44 g/day).
  • - Azathioprine (≤ 2 mg/kg/day).
  • - Methotrexate (≤ 25 mg/week).
  • - Oral Corticosteroids (OCS): - if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.
  • - if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.
  • - Belimumab (≤10 mg/kg every 4 weeks intravenously [i.v.], or 200 mg/week subcutaneously [s.
c.]). Treatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate or belimumab must have been started at least 90 days prior to Screening. Treatment with OCS must have been started at least 30 days prior to Screening. • For women of childbearing potential (WoCBP):
  • - Negative serum pregnancy test at Screening.
  • - Agreement to undertake monthly urine pregnancy tests from Randomization up to 6 months after study treatment discontinuation.
  • - Agreement to use a highly effective method of contraception from Screening (Visit 1) up to 6 months after study treatment discontinuation.
Inclusion criteria at randomization:
  • - A clinical mSLEDAI-2K score ≥ 4 with at least 2 points for musculoskeletal or mucocutaneous manifestations (i.e., myositis, arthritis, rash, alopecia, mucosal ulcers).
  • - BILAG Grade B in 2 or more organ systems or a BILAG Grade A in 1 or more organ system.
  • - PGA score ≥ 1.0 on a 0 to 3 visual analog scale.
  • - Presence of at least one of the following biomarkers of serological evidence of active SLE (in a Screening sample as measured by central laboratory): - Anti-dsDNA antibodies elevated above normal, - Antinuclear antibodies with a titer of at least 1:160, - Anti-Smith antibody elevated above normal.
  • - Currently treated with one or more of the following SLE background medications that must be stable for at least 30 days prior to Randomization (except OCS, which must be stable for at least 15 days prior to Randomization): - Antimalarials (≤ 400 mg/day hydroxychloroquine, ≤ 500 mg/day chloroquine, ≤ 100 mg/day quinacrine); - Mycophenolate mofetil (≤ 2 g/day) / mycophenolic acid (≤ 1.44g/day); - Azathioprine (≤ 2 mg/kg/day); - Methotrexate (≤ 25 mg/week); - OCS: - if OCS is the only SLE background medication: ≥ 7.5 mg/day and ≤ 30 mg/day prednisone or equivalent.
  • - if OCS is not the only SLE background medication: ≤ 30 mg/day prednisone or equivalent.
  • - Belimumab (≤ 10 mg/kg every 4 weeks i.v. or ≤ 200 mg/week s.
c.).
  • - WoCBP must have a negative urine pregnancy test at Randomization.
Main

Exclusion Criteria:

  • - Pregnant, planning to be become pregnant up to Final Study Visit, or lactating women.
  • - Severe active central nervous system lupus or active severe or unstable neuropsychiatric SLE including but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; or mononeuritis multiplex: - That would make the subject unable to fully understand the ICF; OR.
  • - Where, in the opinion of the investigator/delegate, protocol-specified standard of care is insufficient and the use of a more aggressive therapeutic approach, such as adding i.v. cyclophosphamide and/or high dose i.v. pulse corticosteroid (CS) therapy or other treatments not permitted in the protocol is indicated.
  • - A diagnosis of mixed connective tissue disease or any history of overlap syndromes of SLE with psoriasis, rheumatoid arthritis, erosive arthritis, scleroderma, autoimmune hepatitis or uncontrolled autoimmune thyroid disease.
  • - History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia or syncope associated with cardiac disorders.
  • - Subjects who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III/IV within 6 months prior to Screening.
  • - Resting heart rate < 50 bpm as measured by the 12-lead ECG at Screening or at Randomization.
  • - An elevated QT interval corrected according to Fridericia's formula (QTcF) interval of > 470 ms (females) / > 450 ms (males) at Screening or at Randomization.
  • - History or presence of severe respiratory disease or pulmonary fibrosis, based on medical history, lung function, and chest X-ray (or CT scan as per local guidelines), performed at Screening or within 6 months prior to Screening.
  • - History of clinically relevant bronchial asthma or chronic obstructive pulmonary disease that has required treatment with oral or parenteral CS for more than a total of 2 weeks within the last 6 months prior to Screening.
  • - History or presence of malignancy (except for surgically excised and non-recurrent cutaneous basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma), lymphoproliferative disease, or history of total lymphoid irradiation within 10 years prior to Screening.
  • - Presence of any of the following abnormalities detected during the ophthalmological evaluation and/or by optical coherence tomography (OCT) during screening: - Macular edema of any cause: diabetic, cystoid, tractional.
  • - Foveal degeneration, macular hole, macular pseudohole, hereditary or degenerative maculopathies.
  • - Active uveitis, papilledema.
  • - Retinal neovascularization of any cause and in any location.
  • - History of chronic liver or biliary disease (other than Gilbert's Syndrome) or subjects with alanine aminotransferase or aspartate aminotransferase > 3 × Upper Limit of Normal (ULN) or total bilirubin > 1.5 × ULN (unless in the context of known Gilbert's Syndrome).
  • - Significant hematology abnormality at screening assessment: - lymphocyte count < 500 /μL (0.5 × 10^9/L); - hemoglobin < 7 g/dL; - white blood cell count < 2000/μL (2.0 × 10^9/L); or.
  • - platelets < 25000/μL (25 × 10^9/L).
  • - Estimated glomerular filtration rate < 15 mL/min/1.73 m^2.
  • - Treatment with the following medications within 15 days or 5 half-lives of the medication (whichever is longer) prior to Randomization: - β-blockers, diltiazem, verapamil, digoxin, digitoxin, or any other anti-arrhythmic or heart-rate -lowering systemic therapy.
  • - QT-prolonging drugs with known risk of torsade de pointes irrespective of indication.
  • - Treatment with the following medications within 30 days or 5 half-lives of the medication (whichever is longer) prior to Randomization: - Cyclophosphamide, cyclosporine, voclosporin, tacrolimus, sirolimus, etc. - Pulse methylprednisolone.
  • - Vaccination with live vaccines (including live vaccines for COVID-19).
  • - Intra-articular, intramuscular or i.v. CS within 6 weeks prior to Randomization.
  • - Treatment with the following medications within 90 days or 5 half-lives of the medication (whichever is longer) prior to Randomization: - Leflunomide.
  • - i.v. immunoglobulins.
  • - Treatment with any investigational agent within 90 days or 5 half-lives of the drug (whichever is longer) prior to Randomization.
  • - Treatment with B cell-depleting biological agents (e.g., rituximab or ocrelizumab) or biological immunosuppressive agents (e.g., anti-tumor necrosis factor [TNF], anti-interleukin [IL]-1, anti-IL6 therapies), within 12 months prior to Randomization.
  • - Treatment with anifrolumab within 6 months prior to Randomization.
  • - Treatment with any of the following medications any time prior to Screening: - Alemtuzumab, - Sphingosine-1-phosphate receptor modulators (e.g., fingolimod), - Subjects previously randomized to cenerimod or placebo in any trial involving cenerimod.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05648500
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Idorsia Pharmaceuticals Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Idorsia Pharmaceuticals Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Brazil, Bulgaria, Colombia, France, Greece, India, Mexico, Philippines, Poland, Romania, South Korea, Taiwan, Thailand, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lupus Erythematosus, Systemic
Arms & Interventions

Arms

Experimental: Cenerimod 4 mg

Participants will receive cenerimod once daily in addition to background SLE therapy.

Placebo Comparator: Matching placebo

Participants will receive matching placebo once daily in addition to background SLE therapy.

Interventions

Drug: - Cenerimod

Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg.

Drug: - Placebo

Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Providence Medical Foundation, Fullerton 5351247, California 5332921

Status

Withdrawn

Address

Providence Medical Foundation

Fullerton 5351247, California 5332921, 92835

California Research Institute, Huntington Park 5358736, California 5332921

Status

Recruiting

Address

California Research Institute

Huntington Park 5358736, California 5332921, 90255

University of Colorado Denver, Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

University of Colorado Denver

Aurora 5412347, Colorado 5417618, 80045

RASF-Clinical Research Inc., Boca Raton 4148411, Florida 4155751

Status

Withdrawn

Address

RASF-Clinical Research Inc.

Boca Raton 4148411, Florida 4155751, 33486

Clinical Research of West Florida, Inc., Clearwater 4151316, Florida 4155751

Status

Recruiting

Address

Clinical Research of West Florida, Inc.

Clearwater 4151316, Florida 4155751, 33765

Omega Research MetroWest, LLC, DeBary 4152926, Florida 4155751

Status

Recruiting

Address

Omega Research MetroWest, LLC

DeBary 4152926, Florida 4155751, 32713

SouthCoast Research Center, Inc., Miami 4164138, Florida 4155751

Status

Recruiting

Address

SouthCoast Research Center, Inc.

Miami 4164138, Florida 4155751, 33136

IRIS Research and Development, LLC, Plantation 4168782, Florida 4155751

Status

Recruiting

Address

IRIS Research and Development, LLC

Plantation 4168782, Florida 4155751, 33324-2736

Renew Health Clinical Research LLC, Tampa 4174757, Florida 4155751

Status

Withdrawn

Address

Renew Health Clinical Research LLC

Tampa 4174757, Florida 4155751, 33607

Augusta University, Augusta 4180531, Georgia 4197000

Status

Recruiting

Address

Augusta University

Augusta 4180531, Georgia 4197000, 30912

Advance Quality Medical Research, Orland Park 4904937, Illinois 4896861

Status

Recruiting

Address

Advance Quality Medical Research

Orland Park 4904937, Illinois 4896861, 60462

Lake Charles 4330236, Louisiana 4331987

Status

Recruiting

Address

Accurate Clinical Research Inc. - Lake Charles

Lake Charles 4330236, Louisiana 4331987, 70605

New Orleans 4335045, Louisiana 4331987

Status

Not yet recruiting

Address

Louisiana State University School of Medicine section of Rheumatology

New Orleans 4335045, Louisiana 4331987, 70112

Axon Clinical Research -Baltimore, Baltimore 4347778, Maryland 4361885

Status

Recruiting

Address

Axon Clinical Research -Baltimore

Baltimore 4347778, Maryland 4361885, 21237

Klein & Associates, M.D., P.A., Hagerstown 4357141, Maryland 4361885

Status

Withdrawn

Address

Klein & Associates, M.D., P.A.

Hagerstown 4357141, Maryland 4361885, 21740

June DO, PC, Lansing 4998830, Michigan 5001836

Status

Withdrawn

Address

June DO, PC

Lansing 4998830, Michigan 5001836, 48911

Bronx Care Health and Wellness Center, The Bronx 5110266, New York 5128638

Status

Recruiting

Address

Bronx Care Health and Wellness Center

The Bronx 5110266, New York 5128638, 10457

DJL Clinical Research, PLLC, Charlotte 4460243, North Carolina 4482348

Status

Recruiting

Address

DJL Clinical Research, PLLC

Charlotte 4460243, North Carolina 4482348, 28210

Superior Clinical Reseach LLC, Smithfield 4492168, North Carolina 4482348

Status

Recruiting

Address

Superior Clinical Reseach LLC

Smithfield 4492168, North Carolina 4482348, 27577

Oklahoma City 4544349, Oklahoma 4544379

Status

Not yet recruiting

Address

University of Oklahoma College of Medicine

Oklahoma City 4544349, Oklahoma 4544379, 73117

Philadelphia 4560349, Pennsylvania 6254927

Status

Withdrawn

Address

Temple University Health Systems/ Lewis Katz School of Medicine

Philadelphia 4560349, Pennsylvania 6254927, 19140

Shelby Research, LLC, Memphis 4641239, Tennessee 4662168

Status

Withdrawn

Address

Shelby Research, LLC

Memphis 4641239, Tennessee 4662168, 38119-5214

Allen Arthritis, Allen 4670300, Texas 4736286

Status

Withdrawn

Address

Allen Arthritis

Allen 4670300, Texas 4736286, 75013

Accurate Clinical Research Inc., Baytown 4672731, Texas 4736286

Status

Recruiting

Address

Accurate Clinical Research Inc.

Baytown 4672731, Texas 4736286, 77521

Rheumatology Care Center, PLLC, Bellaire 4673353, Texas 4736286

Status

Recruiting

Address

Rheumatology Care Center, PLLC

Bellaire 4673353, Texas 4736286, 77041

Metroplex Clinical Research Center, Dallas 4684888, Texas 4736286

Status

Withdrawn

Address

Metroplex Clinical Research Center

Dallas 4684888, Texas 4736286, 75231

Houston MD Medspa and Wellness Clinic, Houston 4699066, Texas 4736286

Status

Recruiting

Address

Houston MD Medspa and Wellness Clinic

Houston 4699066, Texas 4736286, 77084

Accurate Clinical Research Inc., Houston 4699066, Texas 4736286

Status

Recruiting

Address

Accurate Clinical Research Inc.

Houston 4699066, Texas 4736286, 77089

Sun Research Institute, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

Sun Research Institute

San Antonio 4726206, Texas 4736286, 78215

International Sites

Fundación Respirar, Buenos Aires 3435910, Argentina

Status

Recruiting

Address

Fundación Respirar

Buenos Aires 3435910, , 1426

Instituto Medico CER, Buenos Aires 3435910, Argentina

Status

Recruiting

Address

Instituto Medico CER

Buenos Aires 3435910, , B1878DVB

Aprillus Asistencia e Investigacion, Buenos Aires 3435910, Argentina

Status

Recruiting

Address

Aprillus Asistencia e Investigacion

Buenos Aires 3435910, , C1046AGA

Hospital Ramos Mejia, Buenos Aires 3435910, Argentina

Status

Recruiting

Address

Hospital Ramos Mejia

Buenos Aires 3435910, , C1221ADC

Arsema Clinica Adventista Belgrano, Buenos Aires 3435910, Argentina

Status

Recruiting

Address

Arsema Clinica Adventista Belgrano

Buenos Aires 3435910, , C1430EGF

Mendoza 3844421, Argentina

Status

Recruiting

Address

IR Medical Center /Hospital de Día/ Instituto de Reumatología y Traumatología

Mendoza 3844421, , M5500CPH

Instituto CAICI SRL, Rosario 3838583, Argentina

Status

Recruiting

Address

Instituto CAICI SRL

Rosario 3838583, , S2000PBJ

San Miguel de Tucumán 3836873, Argentina

Status

Recruiting

Address

Centro de investigaciones medicas Tucuman

San Miguel de Tucumán 3836873, , T4000AXL

Centro Integral de Reumatología, San Miguel de Tucumán 3836873, Argentina

Status

Recruiting

Address

Centro Integral de Reumatología

San Miguel de Tucumán 3836873, , T4000DVB

ICT (Investigaciones Clínicas Tucumán), San Miguel de Tucumán 3836873, Argentina

Status

Recruiting

Address

ICT (Investigaciones Clínicas Tucumán)

San Miguel de Tucumán 3836873, , T4000ICL

Santa Casa de Belo Horizonte, Belo Horizonte 3470127, Brazil

Status

Recruiting

Address

Santa Casa de Belo Horizonte

Belo Horizonte 3470127, , 30150-320

Hospital Brasília, Brasília 3469058, Brazil

Status

Withdrawn

Address

Hospital Brasília

Brasília 3469058, , 71635-580

Centro Mineiro de Pesquisas, Juiz de Fora 3459505, Brazil

Status

Active, not recruiting

Address

Centro Mineiro de Pesquisas

Juiz de Fora 3459505, , 36010-570

Instituto Méderi de Pesquisa e Saúde, Passo Fundo 3454857, Brazil

Status

Active, not recruiting

Address

Instituto Méderi de Pesquisa e Saúde

Passo Fundo 3454857, , 99010-120

Porto Alegre 3452925, Brazil

Status

Recruiting

Address

Centro Multidisciplinar de Pesquisa Clínica (Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre 3452925, , 90050-170

LMK Servicos Medico S/S, Porto Alegre 3452925, Brazil

Status

Recruiting

Address

LMK Servicos Medico S/S

Porto Alegre 3452925, , 90480

Rio de Janeiro 3451190, Brazil

Status

Recruiting

Address

IMPAR SERVICOS HOSPITALARES S/A ; Hospital São Lucas

Rio de Janeiro 3451190, , 22061-080

Salvador 3450554, Brazil

Status

Recruiting

Address

SER - Serviços Especializados em Reumatologia da Bahia

Salvador 3450554, , 40150-150

Hospital de Clínicas de Porto Alegre, Santa Cecília 3450376, Brazil

Status

Not yet recruiting

Address

Hospital de Clínicas de Porto Alegre

Santa Cecília 3450376, , 90035-903

São Bernardo do Campo 3449344, Brazil

Status

Not yet recruiting

Address

Centro Multidiciplinar de Estudos Clínicos- CEMEC

São Bernardo do Campo 3449344, , 09715-090

São José do Rio Preto 3448639, Brazil

Status

Recruiting

Address

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto 3448639, , 15090-000

CPClin - Centro de Pesquisas Clínicas, São Paulo 3448439, Brazil

Status

Recruiting

Address

CPClin - Centro de Pesquisas Clínicas

São Paulo 3448439, , 01228-200

Uberlândia 3445831, Brazil

Status

Recruiting

Address

Ebserh Hospital de Clínicas da Universidade Federal de Uberlândia-HC-UFU

Uberlândia 3445831, , 38402-028

Plovdiv 728193, Bulgaria

Status

Recruiting

Address

University Multi-profile Hospital for Active Treatment - Plovdiv AD

Plovdiv 728193, , 4001

Plovdiv 728193, Bulgaria

Status

Recruiting

Address

"University Multiprofile Hospital for Active Treatment - Pulmed" OOD

Plovdiv 728193, , 4002

Medical Center ArtMed OOD, Plovdiv 728193, Bulgaria

Status

Recruiting

Address

Medical Center ArtMed OOD

Plovdiv 728193, , 4002

Plovdiv 728193, Bulgaria

Status

Recruiting

Address

Outpatient Clinic for Specialized Outpatient Medical Care - Medical Center Kyuchuk Parizh Ltd.

Plovdiv 728193, , 4004

DCC 1 Ruse, Rousse 727523, Bulgaria

Status

Recruiting

Address

DCC 1 Ruse

Rousse 727523, , 7000

DCC "Sveta Anna" EOOD, Sofia 727011, Bulgaria

Status

Not yet recruiting

Address

DCC "Sveta Anna" EOOD

Sofia 727011, , 1750

Sofia 727011, Bulgaria

Status

Recruiting

Address

Acibadem City Clinic Diagnostic-Consultative Center" EOOD, 127 Okolovrasten pat, Mladost

Sofia 727011, , 1784

DCC Equita EOOD, Varna 726050, Bulgaria

Status

Recruiting

Address

DCC Equita EOOD

Varna 726050, , 9000

Clínica de la costa Ltda., Barranquilla 3689147, Colombia

Status

Recruiting

Address

Clínica de la costa Ltda.

Barranquilla 3689147, , 080020

Bluecare salud SAS, Bogotá 3688689, Colombia

Status

Recruiting

Address

Bluecare salud SAS

Bogotá 3688689, , 110221

Bogotá 3688689, Colombia

Status

Recruiting

Address

IDEARG (Instituto de Enfermedades Autoinmunes Renato Guzmán)

Bogotá 3688689, , 110221

SERVIMED S.A.S Bucaramanga, Bucaramanga 3688465, Colombia

Status

Recruiting

Address

SERVIMED S.A.S Bucaramanga

Bucaramanga 3688465, , 680003

Preventive Care SAS, Chía 3686675, Colombia

Status

Recruiting

Address

Preventive Care SAS

Chía 3686675, , 250001

Hospital Pablo Tobón Uribe, Medellín 3674962, Colombia

Status

Recruiting

Address

Hospital Pablo Tobón Uribe

Medellín 3674962, , 050034

Montería 3674453, Colombia

Status

Withdrawn

Address

Fundación Centro De Excelencia En Enfermedades Crónicas No Transmisibles-FUNCENTRA

Montería 3674453, , 230003

Fundación Valle de Lili, Santiago de Cali 3687925, Colombia

Status

Recruiting

Address

Fundación Valle de Lili

Santiago de Cali 3687925, , 760032

Santiago de Cali 3687925, Colombia

Status

Recruiting

Address

Centro de Estudios de Reumatología y Dermatología

Santiago de Cali 3687925, , 760042

Healthy Medical Center SAS, Zipaquirá 3665542, Colombia

Status

Recruiting

Address

Healthy Medical Center SAS

Zipaquirá 3665542, , 250252

Hôpital Pitié-Salpêtrière, Paris 2988507, France

Status

Recruiting

Address

Hôpital Pitié-Salpêtrière

Paris 2988507, , 75013

CHU Félix Guyon Site Nord, Saint-Denis 2980916, France

Status

Recruiting

Address

CHU Félix Guyon Site Nord

Saint-Denis 2980916, , 97400

CHU de Purpan, Toulouse 2972315, France

Status

Recruiting

Address

CHU de Purpan

Toulouse 2972315, , 31059

Naval Hospital of Athens, Athens 264371, Greece

Status

Recruiting

Address

Naval Hospital of Athens

Athens 264371, , 115 21

Athens 264371, Greece

Status

Recruiting

Address

General Hospital of Athens "Hippokration"

Athens 264371, , 11527

General Hospital of Athens "Laiko", Athens 264371, Greece

Status

Recruiting

Address

General Hospital of Athens "Laiko"

Athens 264371, , 11527

University General Hospital "Attikon", Athens 264371, Greece

Status

Recruiting

Address

University General Hospital "Attikon"

Athens 264371, , 124 62

General University Hospital of Larissa, Larissa 258576, Greece

Status

Recruiting

Address

General University Hospital of Larissa

Larissa 258576, , 41110

General University Hospital of Patras, Pátrai 255683, Greece

Status

Recruiting

Address

General University Hospital of Patras

Pátrai 255683, , 26504

Euromedica - Kyanos Stavros, Thessaloniki 734077, Greece

Status

Recruiting

Address

Euromedica - Kyanos Stavros

Thessaloniki 734077, , 546 36

Thessaloniki 734077, Greece

Status

Recruiting

Address

General Hospital of Thessaloniki "Hippokration"

Thessaloniki 734077, , 546 42

424 General Military Hospital, Thessaloniki 734077, Greece

Status

Recruiting

Address

424 General Military Hospital

Thessaloniki 734077, , 56429

Assured Care Plus Hospital, Maharashtra, India

Status

Not yet recruiting

Address

Assured Care Plus Hospital

Maharashtra, , 422101

Cuernavaca 3529947, Mexico

Status

Withdrawn

Address

Panamerican Clinical Research Mexico S.A. de C.V.

Cuernavaca 3529947, , 62290

Consultorio Privado de Especialidad, Guadalajara 4005539, Mexico

Status

Recruiting

Address

Consultorio Privado de Especialidad

Guadalajara 4005539, , 44650

Guadalajara 4005539, Mexico

Status

Recruiting

Address

Centro de Estudios de Investigación Básica y Clínica, S.C.

Guadalajara 4005539, , 44690

León 3998655, Mexico

Status

Active, not recruiting

Address

Consultorio Médico de Reumatología - Hospital Aranda de la Parra

León 3998655, , 37000

Biológicos Especializados S.A. de C.V., Mexico City 3530597, Mexico

Status

Recruiting

Address

Biológicos Especializados S.A. de C.V.

Mexico City 3530597, , 06700

Mexico City 3530597, Mexico

Status

Recruiting

Address

CITER, Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.

Mexico City 3530597, , 06700

Mérida 3523349, Mexico

Status

Recruiting

Address

Unidad de Atención Médica e Investigación en Salud

Mérida 3523349, , 97000

Morelia 3995402, Mexico

Status

Recruiting

Address

Centro de Investigación Clínica Chapultepec S. A. de C. V.

Morelia 3995402, , 58260

SMIQ, S. de R.L. de C.V., Querétaro 3816887, Mexico

Status

Recruiting

Address

SMIQ, S. de R.L. de C.V.

Querétaro 3816887, , 76070

San Luis Potosí City 3985606, Mexico

Status

Recruiting

Address

Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

San Luis Potosí City 3985606, , 78200

San Luis Potosí City 3985606, Mexico

Status

Not yet recruiting

Address

Unidad de Investigaciones Reumatológicas A.C

San Luis Potosí City 3985606, , 78290

Zapopan 3979770, Mexico

Status

Recruiting

Address

Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

Zapopan 3979770, , 45070

Chong-Hua Hospital, Cebu City 1717512, Philippines

Status

Recruiting

Address

Chong-Hua Hospital

Cebu City 1717512, , 6000

Davao Doctors Hospital, Davao City 1715348, Philippines

Status

Recruiting

Address

Davao Doctors Hospital

Davao City 1715348, , 8000

Mary Mediatrix Medical Center, Lipa 1706091, Philippines

Status

Recruiting

Address

Mary Mediatrix Medical Center

Lipa 1706091, , 4217

Makati Medical Center, Makati 1703414, Philippines

Status

Recruiting

Address

Makati Medical Center

Makati 1703414, , 1229

UP-PGH, Manila 1701668, Philippines

Status

Recruiting

Address

UP-PGH

Manila 1701668, , 1000

Quezon City 1692192, Philippines

Status

Recruiting

Address

Far Eastern University - Nicanor Reyes Medical Foundation

Quezon City 1692192, , 1118

Jose R. Reyes Memorial Medical Center, Santa Cruz 1688216, Philippines

Status

Recruiting

Address

Jose R. Reyes Memorial Medical Center

Santa Cruz 1688216, , 1003/1014

Centrum Medyczne Pratia Częstochowa, Częstochowa 3100946, Poland

Status

Recruiting

Address

Centrum Medyczne Pratia Częstochowa

Częstochowa 3100946, , 42-200

Centrum Medyczne Angelius Provita, Katowice 3096472, Poland

Status

Recruiting

Address

Centrum Medyczne Angelius Provita

Katowice 3096472, , 40-611

Vita Longa Sp. z o.o., Katowice 3096472, Poland

Status

Recruiting

Address

Vita Longa Sp. z o.o.

Katowice 3096472, , 40-748

Małopolskie Badania Kliniczne, Krakow 3094802, Poland

Status

Recruiting

Address

Małopolskie Badania Kliniczne

Krakow 3094802, , 30-002

Centrum Medyczne Plejady, Krakow 3094802, Poland

Status

Recruiting

Address

Centrum Medyczne Plejady

Krakow 3094802, , 30-363

Zespół Poradni Specjalistycznych REUMED, Lublin 765876, Poland

Status

Recruiting

Address

Zespół Poradni Specjalistycznych REUMED

Lublin 765876, , 20-607

Malwa-Med Iwona Chlebicka, Wroclaw 3081368, Poland

Status

Recruiting

Address

Malwa-Med Iwona Chlebicka

Wroclaw 3081368, , 50-304

Neomed Brasov, Brasov 683844, Romania

Status

Recruiting

Address

Neomed Brasov

Brasov 683844, , 500285

SC Sana Monitoring SRL, Bucharest 683506, Romania

Status

Withdrawn

Address

SC Sana Monitoring SRL

Bucharest 683506, , 11025

Delta Health Care SRL, Bucharest 683506, Romania

Status

Recruiting

Address

Delta Health Care SRL

Bucharest 683506, , 14142

Spitalul Clinic Dr. Ion Cantacuzino, Bucharest 683506, Romania

Status

Withdrawn

Address

Spitalul Clinic Dr. Ion Cantacuzino

Bucharest 683506, , 30167

Craiova 680332, Romania

Status

Recruiting

Address

Spitalul Clinic Judetean de Urgentã Craiova

Craiova 680332, , 200642

SC Medaudio-Optica SRL, Râmnicu Vâlcea 668872, Romania

Status

Recruiting

Address

SC Medaudio-Optica SRL

Râmnicu Vâlcea 668872, , 240762

Pusan National University Hospital, Busan 1838524, South Korea

Status

Recruiting

Address

Pusan National University Hospital

Busan 1838524, , 49241

Daegu 1835329, South Korea

Status

Active, not recruiting

Address

Catholic University of Daegu (Daegu Catholic University Medical Center)

Daegu 1835329, , 42472

Seoul National University Hospital, Junggu 8606540, South Korea

Status

Recruiting

Address

Seoul National University Hospital

Junggu 8606540, , 03080

Seoul 1835848, South Korea

Status

Recruiting

Address

Hanyang University Hospital, Seongdong-gu

Seoul 1835848, , 04763

Seoul 1835848, South Korea

Status

Active, not recruiting

Address

Ewha University Mokdong Hospital, Yangcheon-gu

Seoul 1835848, , 07985

Seoul 1835848, South Korea

Status

Recruiting

Address

KonKuk University Medical Center, Gwangjin-gu

Seoul 1835848, , 5030

Seoul 1835848, South Korea

Status

Recruiting

Address

Seoul Saint Mary's Hospital of the Catholic University of Korea, Seocho-gu

Seoul 1835848, , 6591

Kaohsiung Medical University Hospital, Kaohsiung City 1673820, Taiwan

Status

Recruiting

Address

Kaohsiung Medical University Hospital

Kaohsiung City 1673820, , 807

Far Eastern Memorial Hospital, New Taipei City 12908892, Taiwan

Status

Recruiting

Address

Far Eastern Memorial Hospital

New Taipei City 12908892, , 220

China Medical University Hospital, Taichung 1668399, Taiwan

Status

Recruiting

Address

China Medical University Hospital

Taichung 1668399, , 404

Chi Mei Medical Center, Tainan City 1668355, Taiwan

Status

Recruiting

Address

Chi Mei Medical Center

Tainan City 1668355, , 71004

National Taiwan University Hospital, Taipei 1668341, Taiwan

Status

Recruiting

Address

National Taiwan University Hospital

Taipei 1668341, , 10002

Taipei Medical University Hospital, Taipei 1668341, Taiwan

Status

Recruiting

Address

Taipei Medical University Hospital

Taipei 1668341, , 110

Taipei Veterans General Hospital, Taipei 1668341, Taiwan

Status

Recruiting

Address

Taipei Veterans General Hospital

Taipei 1668341, , 11217

Cheng Hsin General Hospital, Taipei 1668341, Taiwan

Status

Recruiting

Address

Cheng Hsin General Hospital

Taipei 1668341, , 112

TRI-Service General Hospital, Taipei 1668341, Taiwan

Status

Recruiting

Address

TRI-Service General Hospital

Taipei 1668341, , 114

Linkou Chang Gung Memorial Hospital, Taoyuan 6696918, Taiwan

Status

Recruiting

Address

Linkou Chang Gung Memorial Hospital

Taoyuan 6696918, , 33305

Vajira Hospital, Bangkok 1609350, Thailand

Status

Recruiting

Address

Vajira Hospital

Bangkok 1609350, , 10300

Khon Kaen 1609776, Thailand

Status

Recruiting

Address

Srinagarind Hospital, Khon Kaen University

Khon Kaen 1609776, , 40002

Songklanagarind Hospital, Songkhla 1606147, Thailand

Status

Recruiting

Address

Songklanagarind Hospital

Songkhla 1606147, , 90110

Cherkasy 710791, Ukraine

Status

Recruiting

Address

Communal Non-Commercial Enterprise "Cherkasy Regional Hospital of Cherkasy Regional Council"

Cherkasy 710791, , 18009

Khmelnytskyi 706369, Ukraine

Status

Recruiting

Address

Communal Non-Commercial Enterprise "Khmelnytsky Regional Hospital" of Khmelnytsky Regional Council

Khmelnytskyi 706369, , 29000

Clinic of Modern Rheumatology, Kyiv 703448, Ukraine

Status

Recruiting

Address

Clinic of Modern Rheumatology

Kyiv 703448, , 02081

Kyiv City Clinical Hospital #3, Kyiv 703448, Ukraine

Status

Recruiting

Address

Kyiv City Clinical Hospital #3

Kyiv 703448, , 02125

Kyiv 703448, Ukraine

Status

Not yet recruiting

Address

Kyiv Railway Clinical Hospital #2 of Branch "Health Center" of Joint-Stock Company "Ukrainian Railway"

Kyiv 703448, , 03049

Kyiv 703448, Ukraine

Status

Recruiting

Address

State Ins Nat Scie Cen M.D.Strazhesko Ins of Cardio Clin

Kyiv 703448, , 03151

Kyiv 703448, Ukraine

Status

Recruiting

Address

Communal Non-Commercial Enterprise of Kyiv Regional Council Kyiv Clinical Regional Hospital, Consultation and Diagnostic Center

Kyiv 703448, , 04106

Volyn Regional Clinical Hospital, Lutsk 702569, Ukraine

Status

Recruiting

Address

Volyn Regional Clinical Hospital

Lutsk 702569, , 43000

Lviv 702550, Ukraine

Status

Recruiting

Address

Com Non-Com Entr of Lviv Reg Coun "Lviv Reg Clin Hos, Rheu Dprt, Danylo Halytsky Lviv Nat Med Uni

Lviv 702550, , 79010

Lviv 702550, Ukraine

Status

Recruiting

Address

Medical Center of Limited Liability Company "Kalyna. Center of Modern Medicine

Lviv 702550, , 79034

Lviv 702550, Ukraine

Status

Recruiting

Address

Medical Centre "Academical Medical Group" LLC

Lviv 702550, , 79044

Uzhhorod 690548, Ukraine

Status

Recruiting

Address

Uzhhorod City Multidisciplinary Clinical Hospital

Uzhhorod 690548, , 88000

Vinnytsia 689558, Ukraine

Status

Recruiting

Address

Private Small-Scale Enterprise Medical Centre "Pulse", Therapeutical Department

Vinnytsia 689558, , 21001

Vinnytsia 689558, Ukraine

Status

Recruiting

Address

Municipal Nonprofit Institution "Vinnytsia City Clinical Hospital #1"

Vinnytsia 689558, , 21029

Zhytomyr 686967, Ukraine

Status

Recruiting

Address

Communal Enterprise "Hospital #1" of Zhytomyr City Council, Consultation and Treatment Department "Scientific Research Center"

Zhytomyr 686967, , 10002