A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Who is this study for? Child to young adult patients with Juvenile Idiopathic Arthritis
What treatments are being studied? Tofacitnib
Status: Completed
Location: See all (104) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:

• Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.

• The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.

• Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.

• Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.

Locations
United States
Arkansas
Arkansas Children's Hospital
Little Rock
California
Loma Linda University Children'S Hospital
Loma Linda
Loma Linda University Clinical Trials Center
Loma Linda
Loma Linda University Eye Institute
Loma Linda
Loma Linda University General Pediatric Clinic - Meridian
Loma Linda
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
Loma Linda
Children's Hospital Los Angeles
Los Angeles
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
San Bernardino
Rady Children's Hospital Center for Pediatric Clinical Research
San Diego
Rady Children's Hospital Rheumatology Clinic
San Diego
Rady Children's Hospital San Diego
San Diego
Rady Children's Hospital San Diego- Education and Office Building
San Diego
Rady Children's Research Pharmacy
San Diego
Connecticut
Connecticut Children's Medical Center
Hartford
Washington, D.c.
Children's National Medical Center
Washington D.c.
IDS Pharmacy
Washington D.c.
Florida
Nicklaus Children's Hospital
Miami
Georgia
Center for Advanced Pediatrics
Atlanta
AU Medical Center
Augusta
Augusta University
Augusta
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
The University of Chicago Medical Center
Chicago
Indiana
Riley Hospital for Children at IU Health
Indianapolis
Massachusetts
Tufts Medical Center - Floating Hospital for Children
Boston
Minnesota
Explorer Clinic, University of Minnesota Children's Hospital
Minneapolis
North Carolina
Atrium Health- Investigational Drug Services
Charlotte
Levine Children's Specialty Center
Charlotte
Pediatric Research
Charlotte
New Jersey
Hackensack University Medical Center
Hackensack
New York
Cohen Children's Medical Center of New York
Lake Success
Columbia University Medical Center-Herbert Irving Pavillion
New York
Montefiore Medical Center
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Oregon
Randall Children's Hospital at Legacy Emanuel
Portland
Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia
Texas
Dell Children's Medical Group, Dell Children's Medical Center
Austin
Texas Children's Hospital- Clinical Care Center
Houston
Texas Children's Hospital- Clinical Research Center
Houston
Texas Children's Hospital- Investigational Pharmacy
Houston
Texas Children's Hospital- Main Hospital
Houston
Texas Children's Hospital/Baylor College of Medicine- Feigin Center
Houston
Utah
Intermountain - Primary Children's Hospital
Salt Lake City
Washington
Seattle Children's Hospital
Seattle
Other Locations
Argentina
Hospital Britanico de Buenos Aires
Caba
Instituto CAICI SRL
Rosario
Centro Medico Privado de Reumatologia
San Miguel De Tucumán
Australia
The Royal Children's Hospital
Parkville
The Children's Hospital at Westmead
Westmead
Belgium
UZ Gent
Ghent
UZ Leuven - Gasthuisberg
Leuven
Brazil
Faculdade de Medicina da UNESP
Botucatu
Hospital Pequeno Príncipe Clinical Research Office
Curitiba
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz De Fora
Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG)
Rio De Janeiro
SER - Serviços Especializados em Reumatologia
Salvador
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo
SPDM - Associacao Paulista para o Desenvolvimento da Medicina
São Paulo
Canada
Alberta Children's Hospital
Calgary
McGill University Health Center, Glen Site
Montreal
British Columbia Children's Hospital
Vancouver
China
Beijing Children's Hospital, Capital Medical University/Rheumatology Department
Beijing
The Children's Hospital Zhejiang University School of Medicine
Hangzhou
Children's Hospital of Soochow University
Suzhou
Germany
PRI - Pediatric Rheumatology Research Institute GmbH
Bad Bramstedt
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin
St. Josef-Stift Sendenhorst
Sendenhorst
India
Institute of Child Health
Kolkata
Institute of Post Graduate Medical Education and Research & SSKM Hospital
Kolkata
Sir Ganga Ram Hospital
New Delhi
Nirmal Hospital Pvt Ltd.
Surat
Israel
Rambam Health Care Campus
Haifa
Meir Medical Center - Pediatric Clinic
Kfar Saba
Chaim Sheba M.C Tel hashomer
Ramat Gan
Mexico
Clínica de Investigacion en Reumatologia y Obesidad, S.C.
Guadalajara
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey
Centro de Alta Especialidad de Reumatología e Investigación del Potosí, S.C.
San Luis De Potosí
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City
Unidad de Investigaciones Reumatologicas A.C.
San Luis Potosí City
Poland
Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego
Bydgoszcz
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
Krakow
Klinika Kardiologii i Reumatologii Dzieciecej
Lodz
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw
Russian Federation
Federal State Budgetary Scientific Institution
Moscow
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University)
Moscow
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University),
Moscow
FSAI NMRCCH of MOH Russia
Moscow
FSBEI HE St. Petersburg State Pediatric Medical University of the Ministry of Healthcare
Saint Petersburg
State Budgetary Healthcare Institution of Samara Region Tolyatti City Clinical Hospital #5
Tolyatti
Clinic of FSBEI HE BSMU MoH RF
Ufa
FSBEI HE BSMU MoH RF
Ufa
Slovakia
Narodny ustav reumatickych chorob
Piešťany
South Africa
Durban International Clinical Research Site, Enhancing Care Foundation
Durban
Panorama Medical Centre
Panorama
Spain
Hospital Universitario La Paz
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Hospital Universitario y Politecnico La Fe
Valencia
Turkey
Hacettepe University Medical Faculty
Ankara
Umraniye Training and Research Hospital
Istanbul
Istanbul Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Cocuk Romatoloji Bolumu
Kadikoy / Istanbul
Ukraine
Communal Institution Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.
Dnipro
Ivano-Frankivsk Regional Children's Clinical Hospital
Ivano-frankivsk
Communal Non-profit Enterprise
Vinnytsia
United Kingdom
Birmingham Woman's and Children's NHS Foundation Trust
Birmingham
Time Frame
Start Date: 2013-03-18
Completion Date: 2025-02-12
Participants
Target number of participants: 302
Treatments
Experimental: Tofacitinib
All patients will be in tofacitinib treatment group.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov