A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
NCT ID: NCT03000439
Last Updated: 2025-06-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2018-05-10
2024-03-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy Study Of Tofacitinib In Pediatric JIA Population
NCT02592434
Tofacitinib in Juvenile Idiopathic Arthritis
NCT07211932
A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis
NCT01904292
Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis
NCT01500551
A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis
NCT00988221
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tofacitinib 5 mg BID
oral, twice daily, tablet or solution.
In open-label phase: treatment with tofacitinib
Treatment with investigational drug
In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Treatment with investigational drug or placebo
Placebo
In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Treatment with investigational drug or placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
In open-label phase: treatment with tofacitinib
Treatment with investigational drug
In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Treatment with investigational drug or placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Treatment with stable doses of methotrexate (MTX) ≤25 mg/week or ≤20 mg/m2/week, whichever is lower, is permitted;
* Treatment with a stable dose of oral prednisone ≤1 mg/kg/day up to a maximum of 30 mg/day, or equivalent, for at least 1 week before the first study drug dose is permitted.
Exclusion Criteria
* Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with systemic juvenile idiopathic arthritis (sJIA). Current symptoms or findings of more than minimal pleuritis with sJIA.
* Current infection or serious infection within 3 months of study enrollment.
2 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Cohen Children's Medical Center of New York
Lake Success, New York, United States
Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Instituto CAICI SRL
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Universitair Ziekenhuis Gent
Ghent, , Belgium
Faculdade de Medicina da UNESP
Botucatu, São Paulo, Brazil
UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP
Botucatu, São Paulo, Brazil
SPDM - Associacao Paulista para o Desenvolvimento da Medicina
São Paulo, , Brazil
SPDM - Associacao Paulista para o Desenvolvimento da Medicina
São Paulo, , Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, , Brazil
Alberta Children's Hospital/University of Calgary
Calgary, Alberta, Canada
Research Institute of McGill University Health Center, Glen site
Montreal, Quebec, Canada
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Xi'an Children's Hospital
Xi'an, Shaanxi, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
The Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Beijing Children's Hospital, Capital Medical University/Rheumatology Department
Beijing, , China
Hospital Metropolitano
San José, , Costa Rica
Universitaetsklinikum Erlangen
Erlangen, Bavaria, Germany
St. Josef-Stift Sendenhorst
Sendenhorst, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Nirmal Hospital Pvt Ltd
Surat, Gujarat, India
Sir Ganga Ram Hospital
Rajinder Nagar, NEW Delhi, India
Institute of Child Health
Kolkata, West Bengal, India
Institute of Post Graduate Medical Education and Research & SSKM Hospital
Kolkata, West Bengal, India
Rambam Health Care Campus
Haifa, , Israel
Meir Medical Center - Pediatric Clinic
Kfar Saba, , Israel
Istituto Giannina Gaslini Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico
Genova, Genoa, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milan, Italy
Clínica de Investigacion en Reumatologia y Obesidad, S.C.
Guadalajara, Jalisco, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
San Luis Potosí City, , Mexico
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, , Poland
Clinic of FSBEI HE BSMU MoH RF
Ufa, Bashkortostan Republic, Russia
Federal State Budgetary Scientific Institution "Scientific and Research Rheumatology
Moscow, , Russia
Enhancing Care Foundation
Durban, KwaZulu-Natal, South Africa
Panorama Medical Centre
Cape Town, Western Cape, South Africa
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital Department of Pediatric Rheumatology
Kadikoy / Istanbul, , Turkey (Türkiye)
Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.
Dnipro, , Ukraine
Municipal non-Profit Enterprise
Ivano-Frankivsk, , Ukraine
CNE of Lviv Regional Council "Western Ukrainian Specialized Pediatric
Lviv, , Ukraine
Vinnytsia Regional Children's Clinical Hospital
Vinnytsia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-002018-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921165
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.