Last updated on February 2019

A Safety Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA


Brief description of study

A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. Once 31 flares are reported the study will be completed.

Clinical Study Identifier: NCT03000439

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Rady Children's Hospital Center for Pediatric Clinical Research
San Diego, CA United States
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Rady Children's Hospital Rheumatology Clinic
San Diego, CA United States
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San Diego, CA United States
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Rady Children's Hospital San Diego
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Cohen Children's Medical Center of New York
Lake Success, NY United States
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Cohen Children's Medical Center of New York
New Hyde Park, NY United States
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Cincinnati Children's Hospital Medical Center Investigational Drug Service
Cincinnati, OH United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Randall Children's Hospital at Legacy Emanuel
Portland, OR United States
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Children's Hospital of Pittsburgh of UPMC
Pittsburgh, PA United States
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Alberta Children's Hospital, University of Calgary
Calgary, AB Canada
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McGill University Health Center, Glen Site
Montreal, QC Canada
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Research Institute of McGill University Health Center, Glen site
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Primary Children's Hospital
Salt Lake City, UT United States
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Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Argentina
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The Hospital for Sick Children
Toronto, ON Canada
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State Budgetary Healthcare Institution "Republican Pediatric Clinical Hospital" (SBHI RPCH)
Ufa, Russian Federation
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SAHI CRCH MoH TR
Kazan, Russian Federation
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Federal State Budgetary Scientific Institution "Scientific and Research Rheumatology
Moscow, Russian Federation
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Pharmacy of FSBSI SRRI n.a. V.A. Nasonova
Moscow, Russian Federation
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FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),
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University Children's Clinical Hospital of I.M. Sechenov First MSMU
Moscow, Russian Federation
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FSBEI HE SPbSPMU MoH RF
Saint Petersburg, Russian Federation
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Ivano-Frankivsk Regional Children's Clinical Hospital
Ivano-Frankivsk, Ukraine
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State Institution "Institute of Children and Adolescents Health Care" of the NAMS of Ukraine
Kharkiv, Ukraine
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Vinnytsia Regional Children's Clinical Hospital
Vinnytsia, Ukraine
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Instituto CAICI SRL
Rosario, Argentina
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UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP
Botucatu, Brazil
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Faculdade de Medicina da UNESP
Botucatu, Brazil
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Centro Hospitalario Mac, S.A. de C.V. (hospital for emergencies)
Guadalajara, Mexico
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Cl nica de Investigacion en Reumatologia y Obesidad, S.C.
Guadalajara, Mexico
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Hacettepe University Medical Faculty
Ankara, Turkey
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Erciyes University Medical Faculty
Kayseri, Turkey
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Children's Hospital Los Angeles
Los Angeles, CA United States
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Hospital Britanico de Buenos Aires
Caba, Argentina
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Bioreuma
Concepcion, Chile
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Clinical Hospital n. a. S.R. Mirotvortsev of Saratov SMU
Saratov, Russian Federation
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SBHI SR RCCH No. 1
Yekaterinburg, Russian Federation
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State Budgetary Healthcare Institution of Sverdlovsk Region "Regional Children's Clinical Hospital
Yekaterinburg, Russian Federation
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Umraniye Training and Research Hospital, Dep. of Children
Istanbul, Turkey
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Communal Institution of Lviv Regional Council "Western Ukrainian Specialized Pediatric
Lviv, Ukraine
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SPDM - Associacao Paulista para o Desenvolvimento da Medicina
Sao Paulo, Brazil
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Hospital Clinico de Ninos Dr. Roberto del Rio
Santiago, Chile
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Operadora de Hospitales Angeles. S.A. de C.V.
San Luis Potosi, Mexico
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Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
San Luis Potosi, Mexico
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Emmed Research
Pretoria, South Africa
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Istanbul Medeniyet University Medical Faculty
Istanbul, Turkey
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Istanbul University Cerrahpasa Medical Faculty
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Hospital de Cl nicas de Porto Alegre
Porto Alegre, Brazil
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Pediatrics B Ruth Rappaport children's hospital
Haifa, Israel
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Rambam Health Care Campus - Pharmacy
Haifa, Israel
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Meir Medical Center - Pediatric Clinic
Kfar Saba, Israel
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Meir Medical Center- Pharmacy
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Panorama Medical Centre
Cape Town, South Africa
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Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG)
Rio de Janeiro, Brazil
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Phoenix, AZ United States
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Phoenix, AZ United States
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Campinas, Brazil
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Campinas, Brazil
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Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Mexico
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FSAI NMRCCH MoH RF
Moscow, Russian Federation
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Recruitment Status: Open


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