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NCT06133972RecruitingPhase 3

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
550 (estimated)
First submitted
2 Oct 2023
Start date
21 May 2024
Primary completion date
3 Apr 2034
Lead sponsor
Novartis Pharmaceuticals
Diseases
Lupus (SLE)
NCT number
NCT06133972
EU CT number
2023-505929-14-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 550
  • From 21 May 2024 to the primary completion date, 3 Apr 2034
  • 167 sites in 29 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of prohibited therapies.
  • Plans for administration of live vaccines during the study period.

Other illness

  • Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.

Other

  • Pregnant or nursing (lactating) women.
    • Other protocol-defined inclusion/exclusion criteria may apply.

Who the study is looking for

  • Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
  • Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
  • In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.

Age in the registry: 12 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (167)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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CABAArgentinaActive, not recruiting
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La PlataArgentinaRecruiting
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QuilmesArgentinaRecruiting
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San MiguelArgentinaActive, not recruiting
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San Miguel de TucumánArgentinaActive, not recruiting
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MaroochydoreAustraliaRecruiting
University Multiprofile Hospital For Active Treatment Kaspela EOOD
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PlovdivBulgariaRecruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
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SofiaBulgariaRecruiting
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BarretosBrazilRecruiting
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Belo HorizonteBrazilActive, not recruiting
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NiteróiBrazilActive, not recruiting
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Rio de JaneiroBrazilRecruiting
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SalvadorBrazilRecruiting
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São PauloBrazilActive, not recruiting
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VitóriaBrazilRecruiting
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RimouskiCanadaRecruiting
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TorontoCanadaRecruiting
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VancouverCanadaActive, not recruiting
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SantiagoChileRecruiting
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ValdiviaChileRecruiting
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BeijingChinaRecruiting
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ChangchunChinaRecruiting
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ChengduChinaRecruiting
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GuangzhouChinaRecruiting
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LinyiChinaRecruiting
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NanchangChinaActive, not recruiting
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NanjingChinaRecruiting
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NingboChinaRecruiting
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PingxiangChinaRecruiting
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ShanghaiChinaRecruiting
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ShantouChinaRecruiting
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SuzhouChinaRecruiting
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ÜrümqiChinaRecruiting
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WenzhouChinaRecruiting
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XinxiangChinaRecruiting
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BarranquillaColombiaActive, not recruiting
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BogotaColombiaActive, not recruiting
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BucaramangaColombiaActive, not recruiting
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CaliColombiaRecruiting
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ChíaColombiaActive, not recruiting
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MedellínColombiaActive, not recruiting
Revmatologie s.r.o.
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Brno-SeverCzechiaRecruiting
Revmatologicky Ustav
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Prague 2CzechiaRecruiting
MEDICAL PLUS s.r.o.
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Uherské HradištěCzechiaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
University Hospital Cologne AöR
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CologneGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Hospital Germans Trias i Pujol
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BadalonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital General Universitario de Elche
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ElcheSpainRecruiting
Hospital Universitario De Canarias
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La LagunaSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Hospital Universitario Infanta Sofia
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San Sebastián de los ReyesSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Rio Hortega
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ValladolidSpainRecruiting
Complexo Hospitalario Universitario De Vigo
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VigoSpainRecruiting
Hospital Universitario Araba
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VitoriaSpainRecruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceRecruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceRecruiting
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Guatemala CityGuatemalaRecruiting
Qualiclinic Kft.
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BudapestHungaryRecruiting
Semmelweis University
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BudapestHungaryRecruiting
Bekes Varmegyei Koezponti Korhaz
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GyulaHungaryRecruiting
Vita Verum Medical Bt.
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SzékesfehérvárHungaryRecruiting
Belvárosi Egészségház Kft.
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ZalaegerszegHungaryRecruiting
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HaifaIsraelActive, not recruiting
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Ramat GanIsraelRecruiting
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AhmedabadIndiaRecruiting
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KolhāpurIndiaRecruiting
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KozhikodeIndiaRecruiting
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NagpurIndiaRecruiting
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NashikIndiaRecruiting
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New DelhiIndiaRecruiting
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PuneIndiaRecruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyRecruiting
Azienda Ospedaliera Sant'Anna E San Sebastiano Di Caserta
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CasertaItalyRecruiting
University Hospital Of Ferrara
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FerraraItalyRecruiting
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
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MilanItalyRecruiting
Azienda Sanitaria Locale Napoli 1 Centro
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NaplesItalyRecruiting
Azienda Ospedaliera di Padova
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PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
San Camillo Forlanini Hospital
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RomeItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyRecruiting
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Bunkyo KuJapanRecruiting
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Chuo KuJapanRecruiting
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FuchūJapanActive, not recruiting
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NagoyaJapanActive, not recruiting
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OsakaJapanRecruiting
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SapporoJapanActive, not recruiting
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SendaiJapanRecruiting
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Shinjuku KuJapanActive, not recruiting
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tabashi CityJapanActive, not recruiting
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YokohamaJapanActive, not recruiting
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GwangjuSouth KoreaRecruiting
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SeoulSouth KoreaRecruiting
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GuadalajaraMexicoActive, not recruiting
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LeónMexicoRecruiting
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MéridaMexicoRecruiting
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MéxicoMexicoActive, not recruiting
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Mexico CityMexicoActive, not recruiting
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MoreliaMexicoActive, not recruiting
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IpohMalaysiaRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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BydgoszczPolandRecruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandRecruiting
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ
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BytomPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandRecruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.
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WroclawPolandRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local De Saude Da Regiao De Leiria E.P.E.
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LeiriaPortugalRecruiting
Instituto Portugues de Reumatologia
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LisbonPortugalRecruiting
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
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LisbonPortugalRecruiting
Unidade Local De Saude De Lisboa Ocidental E.P.E.
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LisbonPortugalRecruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalRecruiting
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
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BrasovRomaniaRecruiting
Saint Maria Hospital
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BucharestRomaniaRecruiting
Spitalul Clinic Judetean De Urgenta Cluj
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Cluj-NapocaRomaniaRecruiting
Artromac n.o.
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KošiceSlovakiaRecruiting
Zazabie s.r.o.
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Kosice - Stare MestoSlovakiaRecruiting
Univerzitna nemocnica Nemocnica svaeteho Michala a.s.
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Stare MestoSlovakiaRecruiting
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BangkokThailandRecruiting
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MuangThailandRecruiting
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SongkhlaThailandRecruiting
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Kaohsiung CityTaiwanRecruiting
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TaichungTaiwanRecruiting
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TaipeiTaiwanRecruiting
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TaoyuanTaiwanRecruiting
Pinnacle Research Group, LLC
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AnnistonUnited StatesRecruiting
University of Colorado Denver
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AuroraUnited StatesRecruiting
University of Maryland
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BaltimoreUnited StatesActive, not recruiting
Novel Research LLC
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BellaireUnited StatesRecruiting
Providence Medical Center
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BurbankUnited StatesRecruiting
Clinical Res Of W Florida
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ClearwaterUnited StatesRecruiting
GNP Research
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Cooper CityUnited StatesRecruiting
Henry Ford Health
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DetroitUnited StatesRecruiting
Ahmed Arif Medical Research Center
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Grand BlancUnited StatesRecruiting
Homestead Assoc In Research Inc
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HomesteadUnited StatesRecruiting
West Tennessee Research Institute
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JacksonUnited StatesRecruiting
Accurate Clinical Research
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Lake CharlesUnited StatesRecruiting
Advanced Medical Research
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La PalmaUnited StatesRecruiting
Parris and Associates Rheumatology
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LawrencevilleUnited StatesRecruiting
Accurate Clinical Research
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League CityUnited StatesRecruiting
Shelby Research LLC
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MemphisUnited StatesRecruiting
Paramount Med Rsrch and Consult LLC
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Middleburg HeightsUnited StatesRecruiting
UMC New Orleans
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New OrleansUnited StatesActive, not recruiting
University of Pittsburgh
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PittsburghUnited StatesRecruiting
IRIS Research and Development
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PlantationUnited StatesRecruiting
Epic Medical Research
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Red OakUnited StatesRecruiting
Robert A Hozman MD SC
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SkokieUnited StatesCompleted
Clinical Research of West Florida Inc
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TampaUnited StatesRecruiting
Millennium Clinical Trials
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Westlake VillageUnited StatesActive, not recruiting
Willow Rheumatology Wellness
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WillowbrookUnited StatesRecruiting
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Cape TownSouth AfricaRecruiting
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PretoriaSouth AfricaRecruiting
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Somerset WestSouth AfricaRecruiting
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UmhlangaSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.