225
Participants
Start Date
June 10, 2016
Primary Completion Date
May 16, 2019
Study Completion Date
May 16, 2019
CP-690,550 (tofacitinib)
"During the open label run in phase, all subjects will receive active tofacitinib oral tablets or oral solution twice daily (BID) orally, at a dosage based on the subject's body weight as specified below.~During the double blind, placebo controlled phase, subjects will receive either active tofacitinib oral tablets/oral solution or matching placebo oral tablets/oral solution, twice daily (BID), at a dosage specified below.~Body Weight (Dosage in tablet \[BID\] or solution \[BID\]):~5\<7kg (2mg or 2mL); 7\<10kg(2.5mg or 2. mL); 10 \<15kg (3mg or 3mL); 15\<25kg (3.5mg or 3.5mL); 25\<40kg (4mg or 4mL); 40kg (5 mg or 5 ml).~Oral solution (1 mg/mL) is used for subjects \<40 kg. Oral tablets (5 mg) are used for subjects \>=40 kg."
placebo
matching placebo tablet or solution for tofacitinib
The Sydney Children's Hospital Network Westmead, Westmead
UZ Leuven-Gasthuisberg, Leuven
The Royal Children's Hospital, Parkville
Columbia University Medical Center - Herbert Irving Pavilion, New York
Montefiore Medical Center, The Bronx
Pharmacy Department, The Bronx
Cohen Children's Medical Center of New York, New Hyde Park
Cohen Children's Medical Center of NY, Lake Success
The Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
IDS Pharmacy Children's National Medical Center, Washington D.C.
Vinnytsia Regional Children's Clinical Hospital, Vinnytsia
Hospital Universitario Ramon y Cajal, Madrid
Children's Specialty Center, Charlotte
Carolinas HealthCare System IDS Pharmacy, Charlotte
Pediatric Research, Charlotte
Children's Healthcare of Atlanta-Pediatric Research Center, Atlanta
Children's Healthcare of Atlanta, Atlanta
Children's Specialty Services, Atlanta
Augusta University Health Pharmacy, Augusta
Augusta University, Augusta
Nicklaus Children's Hospital, Miami
Istanbul Medeniyet University Medical Faculty, Istanbul
Istanbul University Cerrahpasa Medical Faculty, Istanbul
Umraniye Training and Research Hospital, Istanbul
Erciyes University Medical Faculty, Kayseri
Clinica de Investigacion en Reumatologia y Obesidad, S.C., Guadalajara
Hospital Universitario y Politecnico La Fe, Valencia
IU Health Investigational Drug Services, Indianapolis
Riley Hospital for Children at IU Health, Indianapolis
Chaim Sheba M.C Tel hashomer, Ramat Gan
Journey Clinic: Center for Children with Cancer and Blood Diseases, Uni. of Minnesota Medical Centre, Minneapolis
Pediatric Specialty Care Explorer Clinic, University of Minnesota, Medical Center, Minneapolis
University of Minnesota Medical Center, Fairview IDS Pharmacy, Minneapolis
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
The University of Chicago Medical Center, Chicago
Arkansas Children's Hospital - Attention: Jill Hernandez, Little Rock
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 en Reumatologia e Investigacion del Potosi S.C., San Luis Potosí City
Sociedad de Beneficencia Espanola, A.C., San Luis Potosí City
"Hospital Central Dr. Ignacio Morones Prieto", San Luis Potosí City
Unidad de Investigaciones Reumatologicas A.C., San Luis Potosí City
Dell Children's Medical Center of Central Texas, Austin
Specially for Children, Dell Children's Medical Center of Central Texas, Austin
PCH Pharmacy - Primary Children's Hospital - Pharmacy, Salt Lake City
Primary Children's Hospital, Salt Lake City
Children's Hospital Los Angeles, Los Angeles
Rady Children's Hospital - San Diego, San Diego
Rady Children's Hospital Center for Pediatric Clinical Research, San Diego
Rady Children's Hospital Education and Office Building, San Diego
Rady Children's Hospital Research Pharmacy, San Diego
Rady Children's Hospital Rheumatology Clinic, San Diego
Loma Linda University Children's Hospital, Loma Linda
Loma Linda University Clinical Trial Center, Loma Linda
Loma Linda University Eye Institute, Loma Linda
Loma Linda University General Pediatric Clinic - Meridian, Loma Linda
Pediatric Specialty Team Centers of LLU Children's Hospital, Loma Linda
Pediatric Specialty Team Centers of LU Children's Hospital, San Bernardino
Legacy Emanuel Medical Center - Inpatient Pharmacy, Portland
Randall Children's Hospital at Legacy Emanuel, Portland
Seattle Children's Hospital, Seattle
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 NSPCCH of Minzdrav of Russia", Moscow
"FSBEI HE St. Petersburg State Pediatric Medical University", Saint Petersburg
"State Budgetary Healthcare Institution of Samara Region Tolyatti City Clinical Hospital #5", Tolyatti
Rambam Health Care, Haifa
Meir Medical Center, Kfar Saba
Connecticut Children's Medical Center -Pharmacy, Hartford
Connecticut Children's Medical Center, Hartford
Tufts Medical Center Floating Hospital for Children, Boston
Hackensack University Medical Center, Hackensack
Cincinnati Childrens Hospital Medical Center, Cincinnati
Instituto CAICI SRL, Rosario
Centro Medico Privado de Reumatologia, San Miguel de Tucumán
Hospital Britanico de Buenos Aires, CABA
SER - Servicos Especializados em Reumatologia, Salvador
Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte
Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte
CMIP -Centro Mineiro de Pesquisa Ltda / Reumatocenter, Juiz de Fora
Hospital Pequeno Principe / A ssociacao Hospitalar de Protecao a Infancia, Curitiba
Instituto de Pesquisa Pele Pequeno Principe, Curitiba
Instituto de Puericultura e Pediatria Martagao Gesteira, Rio de Janeiro
Faculdade de Medicina da UNESP, Botucatu
SPDM- Associacao Paulista para o Desenvolvimento da Medicina-Hospital Sao Paulo, São Paulo
Instituto da Crianca do Hospital das Clinicas da FMUSP, São Paulo
Alberta Children's Hospital - Inpatient Pharmacy, Calgary
Alberta Children's Hospital/University of Calgary, Calgary
Children's & Women's Health Centre of B.C., Vancouver
British Columbia Children's Hospital, Vancouver
McGill University Health Canter, Glen site, Pharmacy, Montreal
McGill University Health Center, Glen Site, Center for Innovative Medicine, Montreal
Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego, Bydgoszcz
Hacettepe University Medical Faculty, Ankara
University Hospital Southampton NHS Foundation Trust, Southampton
University Hospital Southampton NHS Foundation Trust, Southampton
Birmingham Woman's and Children's NHS Foundation Trust, Birmingham
Lead Sponsor
Pfizer
INDUSTRY