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

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 10, 2018

Primary Completion Date

March 27, 2024

Study Completion Date

March 27, 2024

Conditions
Arthritis Juvenile Idiopathic
Interventions
DRUG

In open-label phase: treatment with tofacitinib

Treatment with investigational drug

DRUG

In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio

Treatment with investigational drug or placebo

Trial Locations (52)

1094

Semmelweis Egyetem, Budapest

4302

Enhancing Care Foundation, Durban

7500

Panorama Medical Centre, Cape Town

9000

Universitair Ziekenhuis Gent, Ghent

10103

Hospital Metropolitano, San José

11040

Cohen Children's Medical Center of New York, New Hyde Park

11042

Cohen Children's Medical Center of New York, Lake Success

16147

Istituto Giannina Gaslini Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico, Genova

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

21000

Vinnytsia Regional Children's Clinical Hospital, Vinnytsia

28046

Hospital Universitario La Paz, Madrid

34722

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital Department of Pediatric Rheumatology, Kadikoy / Istanbul

44650

Clínica de Investigacion en Reumatologia y Obesidad, S.C., Guadalajara

46026

Hospital Universitario y Politecnico La Fe, Valencia

48324

St. Josef-Stift Sendenhorst, Sendenhorst

49006

"Communal Institution Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.", Dnipro

60611

Ann & Robert H Lurie Children's Hospital of Chicago, Chicago

64460

"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey

76014

Municipal non-Profit Enterprise, Ivano-Frankivsk

78213

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C., San Luis Potosí City

79035

"CNE of Lviv Regional Council Western Ukrainian Specialized Pediatric", Lviv

85016

Phoenix Children's Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

91054

Universitaetsklinikum Erlangen, Erlangen

100045

Beijing Children's Hospital, Capital Medical University/Rheumatology Department, Beijing

110060

Sir Ganga Ram Hospital, Rajinder Nagar

115522

"Federal State Budgetary Scientific Institution Scientific and Research Rheumatology", Moscow

215003

Children's Hospital of Soochow University, Suzhou

310057

The Children's Hospital Zhejiang University School of Medicine, Hangzhou

395002

Nirmal Hospital Pvt Ltd, Surat

401122

Children's Hospital of Chongqing Medical University, Chongqing

410011

The Second Xiangya Hospital of Central South University, Changsha

430030

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan

450083

Clinic of FSBEI HE BSMU MoH RF, Ufa

510623

Guangzhou Women and Children's Medical Center, Guangzhou

610073

Chengdu Women's and Children's Central Hospital, Chengdu

700017

Institute of Child Health, Kolkata

700020

Institute of Post Graduate Medical Education and Research & SSKM Hospital, Kolkata

710003

Xi'an Children's Hospital, Xi'an

3109601

Rambam Health Care Campus, Haifa

4428164

Meir Medical Center - Pediatric Clinic, Kfar Saba

S2000PBJ

Instituto CAICI SRL, Rosario

T4000AXL

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

18618-686

Faculdade de Medicina da UNESP, Botucatu

18618-970

UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP, Botucatu

04024-002

SPDM - Associacao Paulista para o Desenvolvimento da Medicina, São Paulo

04037-002

SPDM - Associacao Paulista para o Desenvolvimento da Medicina, São Paulo

05409-011

Instituto da Crianca do Hospital das Clinicas da FMUSP, São Paulo

T3B 6A8

Alberta Children's Hospital/University of Calgary, Calgary

H4A 3J1

Research Institute of McGill University Health Center, Glen site, Montreal

02-637

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher, Warsaw

06100

Hacettepe University Medical Faculty, Ankara

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03000439 - A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA | Biotech Hunter | Biotech Hunter