Psoriasis Clinical Trial

Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

Summary

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

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Full Description

This is a Phase 2/3, long term, open-label, follow-up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib. Those who have already completed such participation and enroll outside the 14 day window following completion of the End of Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to determine eligibility. A Baseline Visit will then occur within 28 days after the Screening Visit. For subjects who are completing participation in a qualifying study of tofacitinib and enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study. The subjects who enroll within the 14 day window following completion of the EOS Visit of the qualifying/index study will participate in a combined Screening and Baseline Visit for this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3 months, then every 3 months thereafter as long as the subject remains in the study.

Approximately 340 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program.

For subjects who entered this study from the A3921103 and A3921104 qualifying/index studies, their participation in this study ends after the first marketing approval of tofacitinib for the treatment of polyarticular course Juvenile Idiopathic Arthritis (pJIA) in any country. This study will end once the last subject, and all other subjects, who entered from index study A3921165 have completed approximately 1 year in this study, or after the first marketing approval of tofacitinib for the treatment of systemic JIA, whichever comes first.

The total duration of an individual subject's participation may vary depending upon when they enter the trial.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

persistent oligoarthritis, and undifferentiated JIA.

Infections:

Chronic infections.
Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug.
Any treated infections within 2 weeks of baseline visit.
A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
History of infected joint prosthesis with prosthesis still in situ.
History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

275

Study ID:

NCT01500551

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 128 Locations for this study

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Phoenix Children's Hospital- Inpatient Pharmacy
Phoenix Arizona, 85016, United States
Phoenix Children's Hospital
Phoenix Arizona, 85016, United States
Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States
Loma Linda University Children'S Hospital
Loma Linda California, 92354, United States
Loma Linda University Clinical Trials Center
Loma Linda California, 92354, United States
Loma Linda University Eye Institute
Loma Linda California, 92354, United States
Loma Linda University General Pediatric Clinic - Meridian
Loma Linda California, 92354, United States
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
Loma Linda California, 92408, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology)
San Bernardino California, 92408, United States
Rady Children's Hospital Center for Pediatric Clinical Research
San Diego California, 92123, United States
Rady Children's Hospital Education and Office Building
San Diego California, 92123, United States
Rady Children's Hospital Research Pharmacy
San Diego California, 92123, United States
Rady Children's Hospital Rheumatology Clinic
San Diego California, 92123, United States
Rady Children's Hospital San Diego- Education and Office Building
San Diego California, 92123, United States
Rady Children's Hospital San Diego
San Diego California, 92123, United States
Rady Children's Research Pharmacy
San Diego California, 92123, United States
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
IDS Pharmacy
Washington District of Columbia, 20010, United States
Nicklaus Children's Hospital
Miami Florida, 33155, United States
AdventHealth
Orlando Florida, 32803, United States
AdventHealth Investigational Drug Services
Orlando Florida, 32804, United States
AdventHealth Pediatric Outpatient Procedures and Sedation
Orlando Florida, 32804, United States
AHMG Pediatric Rheumatology and Immunology
Orlando Florida, 32804, United States
Johns Hopkins All Children's Hospital
Saint Pertersburg Florida, 33701, United States
All Children's Hospital Speciality Physicians
Saint Petersburg Florida, 33701, United States
Center for Advanced Pediatrics
Atlanta Georgia, 30329, United States
AU Medical Center
Augusta Georgia, 30912, United States
Augusta University Health Pharmacy
Augusta Georgia, 30912, United States
Augusta University
Augusta Georgia, 30912, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago Illinois, 60611, United States
Lurie Rheumatology Offices
Chicago Illinois, 60611, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
Riley Hospital for Children at IU Health
Indianapolis Indiana, 46202, United States
Tufts Medical Center - Floating Hospital for Children
Boston Massachusetts, 02111, United States
Explorer Clinic, University of Minnesota Children's Hospital
Minneapolis Minnesota, 55454, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Cohen Children's Medical Center of New York
Lake Success New York, 11042, United States
Hospital for Special Surgery
New York New York, 10021, United States
Columbia University Medical Center-Herbert Irving Pavillion
New York New York, 10032, United States
UNC Children's Hospital
Chapel Hill North Carolina, 27514, United States
UNC Clinical & Translational Research Unit
Chapel Hill North Carolina, 27599, United States
Pediatric Research
Charlotte North Carolina, 20207, United States
Levine Children's Specialty Center
Charlotte North Carolina, 28203, United States
Atrium Health- Investigational Drug Services
Charlotte North Carolina, 28207, United States
UNC Children's Raleigh
Raleigh North Carolina, 27607, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Randall Children's Hospital at Legacy Emanuel
Portland Oregon, 97227, United States
The Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Dell Children's Medical Group, Dell Children's Medical Center
Austin Texas, 78723, United States
Texas Children's Hospital- Clinical Care Center
Houston Texas, 77030, United States
Texas Children's Hospital- Clinical Research Center
Houston Texas, 77030, United States
Texas Children's Hospital- Investigational Pharmacy
Houston Texas, 77030, United States
Texas Children's Hospital- Main Hospital
Houston Texas, 77030, United States
Texas Children's Hospital/Baylor College of Medicine- Feigin Center
Houston Texas, 77030, United States
Intermountain - Primary Children's Hospital
Salt Lake City Utah, 84113, United States
Seattle Children's Hospital
Seattle Washington, 98105, United States
Instituto CAICI SRL
Rosario Santa FE, S2000, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucuman Tucuman, T4000, Argentina
Hospital Britanico de Buenos Aires
Caba , C1280, Argentina
The Children's Hospital at Westmead
Westmead New South Wales, 2145, Australia
The Royal Children's Hospital
Parkville Victoria, 3052, Australia
Queen Fabiola Children's University Hospital
Brussels , 1020, Belgium
UZ Gent
Gent , 9000, Belgium
UZ Leuven - Gasthuisberg
Leuven , 3000, Belgium
SER - Serviços Especializados em Reumatologia
Salvador Bahia, 40150, Brazil
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz de Fora Minas Gerais, 36010, Brazil
Hospital Pequeno Príncipe Clinical Research Office
Curitiba Parana, 80250, Brazil
Hospital Pequeno Príncipe/
Curitiba Parana, 80250, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre RIO Grande DO SUL, 90035, Brazil
Faculdade de Medicina da UNESP
Botucatu SAO Paulo, 18618, Brazil
Hospital de Clinicas da UNICAMP-Laboratorio de Reumatologia-L06
Campinas SAO Paulo, 13083, Brazil
Hospital de Clinicas da UNICAMP
Campinas SAO Paulo, 13083, Brazil
Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG)
Rio de Janeiro , 21941, Brazil
SPDM - Associacao Paulista para o Desenvolvimento da Medicina
Sao Paulo , 04037, Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP
Sao Paulo , 05409, Brazil
Alberta Children's Hospital
Calgary Alberta, T3B 6, Canada
Teck Acute Care Centre
Vancouver British Columbia, V5Z2H, Canada
C & W Health Centre of BC
Vancouver British Columbia, V6H 3, Canada
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada
The Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
McGill University Health Center, Glen Site, Central Pharmacy
Montreal Quebec, H4A 3, Canada
McGill University Health Center, Glen Site
Montreal Quebec, H4A 3, Canada
Children's Hospital of Chongqing Medical University
Chongqing Chongqing, 40112, China
Guangzhou Women and Children's Medical Center
Guangzhou Guangdong, 51062, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan Hubei, 43003, China
The Second Xiangya Hospital of Central South University
Changsha Hunan, 41001, China
Children's Hospital of Soochow University
Suzhou Jiangsu, 21500, China
Xi'an Children's Hospital
Xi'an Shaanxi, 71000, China
Chengdu Women's and Children's Central Hospital
Chengdu Sichuan, 61007, China
The Children's Hospital Zhejiang University School of Medicine
Hangzhou Zhejiang, 31005, China
Beijing Children's Hospital, Capital Medical University/Rheumatology Department
Beijing , 10004, China
Children's Hospital of Fudan University
Shanghai , 20110, China
Hospital Metropolitano
San Jose , 10103, Costa Rica
Universitaetsklinikum Erlangen Kinder- und Jugendklinik
Erlangen Bayern, 91054, Germany
PRI - Pediatric Rheumatology Research Institute GmbH
Bad Bramstedt , 24576, Germany
HELIOS Klinikum Berlin-Buch
Berlin , 13125, Germany
Universitaets-Kinderklinik Charite SPZ Kinderrheumatologie
Berlin , 13353, Germany
Klinikum Bremen-Mitte, Prof. Hess-Kinderklinik
Bremen , 28177, Germany
Klinikum Bremen-Mitte
Bremen , 28177, Germany
Universitaetsklinikum Carl Gustav Carus Dresden Klinik und Poliklinik fur Kinder-und Jugendmedizin
Dresden , 01307, Germany
Deutsches Zentrum für Kinder- und Jugendrheumatologie
Garmisch-partenkirchen , 82467, Germany
Hamburger Zentrum fur Kinder und Jugendrheumatologie
Hamburg , 22081, Germany
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin , 53757, Germany
St. Josef-Stift Sendenhorst
Sendenhorst , 48324, Germany
Semmelweis Egyetem
Budapest , 1094, Hungary
Nirmal Hospital Pvt Ltd.
Surat Gujarat, 39500, India
Institute of Child Health
Kolkata WEST Bengal, 70001, India
Institute of Post Graduate Medical Education and Research & SSKM Hospital
Kolkata WEST Bengal, 70002, India
Sir Ganga Ram Hospital
New Delhi , 11006, India
Rambam Health Care Campus
Haifa , 31096, Israel
Rambam Health Care
Haifa , 31096, Israel
Meir Medical Center - Pediatric Clinic
Kfar Saba , 44281, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Chaim Sheba M.C Tel hashomer
Ramat Gan , 52621, Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano Milan, 20122, Italy
IRCCS Giannina Gaslini Department/Division
Genova , 16147, Italy
Clínica de Investigacion en Reumatologia y Obesidad, S.C.
Guadalajara Jalisco, 44650, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey Nuevo LEON, 64460, Mexico
Centro de Alta Especialidad de Reumatología e Investigación del Potosí, S.C.
San Luis De Potosí , 78213, Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi , 78290, Mexico
Unidad de Investigaciones Reumatologicas A.C.
San Luis Potosi , 78290, Mexico
Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego
Bydgoszcz , 85-66, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
Krakow , 31-50, Poland
Klinika Kardiologii i Reumatologii Dzieciecej
Lodz , 91-73, Poland
Centrum Pediatrii im. Jana Pawla II w Sosnowcu Sp. z o.o.
Sosnowiec , 41-21, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warszawa , 00-72, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warszawa , 02-63, Poland
FSBEI HE BSMU MoH RF
Ufa Republic OF Bashkortostan, 45000, Russian Federation
Clinic of FSBEI HE BSMU MoH RF
Ufa Republic OF Bashkortostan, 45008, Russian Federation
Federal State Budgetary Scientific Institution
Moscow , 11552, Russian Federation
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University)
Moscow , 11943, Russian Federation
FSAEI HE I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenovskiy University),
Moscow , 11999, Russian Federation
FSAI "NMRCCH" of MOH Russia
Moscow , 11999, Russian Federation
FSBEI HE "St. Petersburg State Pediatric Medical University" of the Ministry of Healthcare
Saint-Petersburg , 19410, Russian Federation
State Budgetary Healthcare Institution of Samara Region "Tolyatti City Clinical Hospital #5"
Tolyatti , 44503, Russian Federation
Narodny ustav detskych chorob, Detska klinika LF UK a NUDCH
Bratislava , 83340, Slovakia
Detska Fakultna nemocnica Kosice
Kosice , 04011, Slovakia
Narodny ustav reumatickych chorob
Piestany , 921 1, Slovakia
Panorama Medical Centre
Panorama Cape Town, 7500, South Africa
Enhancing Care Foundation
Durban Kwazulu-natal, 4302, South Africa
Durban International Clinical Research Site, Enhancing Care Foundation
Durban , 4301, South Africa
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario y Politecnico La Fe
Valencia , 46026, Spain
Hacettepe University Medical Faculty
Ankara , 06100, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Umraniye Training and Research Hospital
Istanbul , 34764, Turkey
Umraniye Training and Research Hospital
Istanbul , 35767, Turkey
Istanbul Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Cocuk Romatoloji Bolumu
Kadikoy / Istanbul , 34722, Turkey
Erciyes University Medical Faculty
Kayseri , 38039, Turkey
Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.
Dnipro , 49006, Ukraine
Ivano-Frankivsk Regional Children's Clinical Hospital
Ivano-Frankivsk , 76014, Ukraine
Communal Non-profit Enterprise
Vinnytsia , 21000, Ukraine
Birmingham Woman's and Children's NHS Foundation Trust
Birmingham WEST Midlands, B4 6N, United Kingdom
NHS Greater Glasgow and Clyde Royal Hospital for Children
Glasgow , G51 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

275

Study ID:

NCT01500551

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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