302
Participants
Start Date
March 18, 2013
Primary Completion Date
February 12, 2025
Study Completion Date
February 12, 2025
Tofacitinib
"Tofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight for all subjects for all three index studies (A3921103, A3921104, and A3921165)~5 mg BID Dose Level:~Body Weight (Dose in tablet \[mg BID\] or solution \[ml BID\]) 5 - \< 7 kg (2 mg or 2 ml) 7 - \< 10 kg (2.5 mg or 2.5 ml) 10 - \<15 kg (3 mg or 3 ml) 15 - \<25 kg (3.5 mg or 3.5 ml) 25 - \<40 kg (4 mg or 4 ml) \>=40 kg (5 mg or 5 ml)~Oral solution (1 mg/mL concentration) will be used for subjects weighing \<40 kg. Oral tablets (5 mg) will be used for subjects weighing \>=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution.~Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing."
Tofacitinib
For subjects rolling over from study A3921103 and actively participating in this study at the time of Protocol Amendment 6 and receiving a dosage of tofacitinib in accordance with the dosing scheme specified in Protocol Amendment 5, investigators will have the option of maintaining the subject's current dosage regimen from index study A3921103 (if the desired clinical response has been attained with no safety concern) or adjusting the dosage regimen in accordance with the dosing scheme specified in this section.
The Children's Hospital at Westmead, Westmead
UZ Leuven - Gasthuisberg, Leuven
The Royal Children's Hospital, Parkville
Durban International Clinical Research Site, Enhancing Care Foundation, Durban
Panorama Medical Centre, Panorama
UZ Gent, Ghent
Columbia University Medical Center-Herbert Irving Pavillion, New York
Montefiore Medical Center, The Bronx
Cohen Children's Medical Center of New York, Lake Success
The Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
IDS Pharmacy, Washington D.C.
Pediatric Research, Charlotte
Communal Non-profit Enterprise, Vinnytsia
Hamburger Zentrum fur Kinder und Jugendrheumatologie, Hamburg
PRI - Pediatric Rheumatology Research Institute GmbH, Bad Bramstedt
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario La Paz, Madrid
Levine Children's Specialty Center, Charlotte
Atrium Health- Investigational Drug Services, Charlotte
Center for Advanced Pediatrics, Atlanta
AU Medical Center, Augusta
Augusta University, Augusta
Nicklaus Children's Hospital, Miami
Istanbul Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Cocuk Romatoloji Bolumu, Kadikoy / Istanbul
Umraniye Training and Research Hospital, Istanbul
Clínica de Investigacion en Reumatologia y Obesidad, S.C., Guadalajara
Cincinnati Children's Hospital Medical Center, Cincinnati
Hospital Universitario y Politecnico La Fe, Valencia
Riley Hospital for Children at IU Health, Indianapolis
St. Josef-Stift Sendenhorst, Sendenhorst
"Communal Institution Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.", Dnipro
Chaim Sheba M.C Tel hashomer, Ramat Gan
Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin
Explorer Clinic, University of Minnesota Children's Hospital, Minneapolis
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
The University of Chicago Medical Center, Chicago
"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey
Arkansas Children's Hospital, Little Rock
Ivano-Frankivsk Regional Children's Clinical Hospital, Ivano-Frankivsk
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
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
Dell Children's Medical Group, Dell Children's Medical Center, Austin
Intermountain - Primary Children's Hospital, Salt Lake City
Children's Hospital Los Angeles, Los Angeles
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- Education and Office Building, San Diego
Rady Children's Hospital San Diego, San Diego
Rady Children's Research Pharmacy, San Diego
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
Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology), San Bernardino
Randall Children's Hospital at Legacy Emanuel, Portland
Seattle Children's Hospital, Seattle
Beijing Children's Hospital, Capital Medical University/Rheumatology Department, Beijing
Sir Ganga Ram Hospital, New Delhi
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
Children's Hospital of Soochow University, Suzhou
The Children's Hospital Zhejiang University School of Medicine, Hangzhou
Nirmal Hospital Pvt Ltd., Surat
"State Budgetary Healthcare Institution of Samara Region Tolyatti City Clinical Hospital #5", Tolyatti
FSBEI HE BSMU MoH RF, Ufa
Clinic of FSBEI HE BSMU MoH RF, Ufa
Institute of Child Health, Kolkata
Institute of Post Graduate Medical Education and Research & SSKM Hospital, Kolkata
Meir Medical Center - Pediatric Clinic, Kfar Saba
Connecticut Children's Medical Center, Hartford
Tufts Medical Center - Floating Hospital for Children, Boston
Hackensack University Medical Center, Hackensack
Instituto CAICI SRL, Rosario
Centro Medico Privado de Reumatologia, San Miguel de Tucumán
Hospital Britanico de Buenos Aires, CABA
SER - Serviços Especializados em Reumatologia, Salvador
CMIP - Centro Mineiro de Pesquisa Ltda, Juiz de Fora
Hospital Pequeno Príncipe Clinical Research Office, Curitiba
Faculdade de Medicina da UNESP, Botucatu
Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG), Rio de Janeiro
SPDM - Associacao Paulista para o Desenvolvimento da Medicina, São Paulo
Instituto da Crianca do Hospital das Clinicas da FMUSP, São Paulo
Alberta Children's Hospital, Calgary
British Columbia Children's Hospital, Vancouver
McGill University Health Center, Glen Site, Montreal
Rambam Health Care Campus, Haifa
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
Narodny ustav reumatickych chorob, Piešťany
Hacettepe University Medical Faculty, Ankara
Birmingham Woman's and Children's NHS Foundation Trust, Birmingham
Lead Sponsor
Pfizer
INDUSTRY