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A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

Primary Purpose

Arthritis Juvenile Idiopathic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
In open-label phase: treatment with tofacitinib
In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis Juvenile Idiopathic focused on measuring systemic Juvenile Idiopathic Arthritis, Xeljanz, Tofacitinib, sJIA, CP-690 550

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • active sJIA disease according to ILAR criteria before screening and at baseline (Day 1);
  • 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:

  • Previous juvenile idiopathic arthritis (JIA) treatment with tofacitinib.
  • 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.

Sites / Locations

  • Phoenix Children's HospitalRecruiting
  • Children's Hospital Los Angeles
  • Children's National Medical Center
  • AdventHealth
  • AdventHealth Pediatric Outpatient Procedures and Sedation
  • AHMG Pediatric Rheumatology and Immunology
  • All Children's Hospital Specialty Physicians
  • AU Medical Center
  • Augusta University
  • Ann & Robert H Lurie Children's Hospital of ChicagoRecruiting
  • Lurie Rheumatology OfficesRecruiting
  • Hackensack University Medical Center
  • Cohen Children's Medical Center of New York
  • Cohen Children's Medical Center of New York
  • Hospital for Special Surgery
  • UNC Children's Hospital
  • UNC Clinical & Translational Research Center
  • UNC Children's Raleigh
  • Cincinnati Children's Hospital Medical Center Investigational Drug ServiceRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • University of Oklahoma Health Sciences Center
  • Randall Children's Hospital at Legacy EmanuelRecruiting
  • PPD Sample Management Department (PK Laboratory)
  • Instituto CAICI SRL
  • Centro Medico Privado de Reumatologia
  • Hopital Universitaire des Enfants Reine Fabiola (HUDERF)
  • Universitair Ziekenhuis GentRecruiting
  • Hospital de Clínicas de Porto Alegre
  • UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESPRecruiting
  • Hospital de Clinicas da UNICAMP
  • Faculdade de Medicina da UNESPRecruiting
  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina
  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina
  • Instituto da Crianca do Hospital das Clinicas da FMUSPRecruiting
  • Alberta Children's Hospital/University of CalgaryRecruiting
  • The Hospital for Sick Children
  • McGill University Health Center, Glen SiteRecruiting
  • Research Institute of McGill University Health Center, Glen siteRecruiting
  • CHU de Québec - Université Laval, Site CHULRecruiting
  • Children's Hospital of Chongqing Medical UniversityRecruiting
  • Guangzhou Women and Children's Medical CenterRecruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & TechnologyRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Children's Hospital of Soochow UniversityRecruiting
  • Xi'an Children's HospitalRecruiting
  • Chengdu Women's and Children's Central HospitalRecruiting
  • The Children's Hospital Zhejiang University School of MedicineRecruiting
  • Beijing Children's Hospital, Capital Medical University/Rheumatology DepartmentRecruiting
  • Children's Hospital of Fudan University
  • Hospital Metropolitano
  • Universitaetsklinikum ErlangenRecruiting
  • HELIOS Kliniken Berlin Buch GmbH
  • HELIOS Klinikum Berlin Buch GmbH
  • Charite - Universitaetsmedizin Berlin, Campus Virchow
  • Gesundheit Nord gGmbH
  • Universitaetsklinikum Carl Gustav Carus Dresden
  • Deutsches Zentrum für Kinder- und Jugendrheumatologie
  • Asklepios Klinik Sankt Augustin GmbH, Zentrum für Allgemeine Pädiatrie und NeonatologieRecruiting
  • St. Josef-Stift Sendenhorst
  • Semmelweis Egyetem
  • Nirmal Hospital Pvt LtdRecruiting
  • Sir Ganga Ram HospitalRecruiting
  • Institute of Child HealthRecruiting
  • Institute of Post Graduate Medical Education and Research & SSKM HospitalRecruiting
  • Rambam Health Care CampusRecruiting
  • Meir Medical Center - Pediatric ClinicRecruiting
  • Meir Medical Center- PharmacyRecruiting
  • Istituto Giannina Gaslini Istituto Pediatrico di Ricovero e Cura a Carattere ScientificoRecruiting
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Clínica de Investigacion en Reumatologia y Obesidad, S.C.Recruiting
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"Recruiting
  • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.Recruiting
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w LodziRecruiting
  • Centrum Pediatrii im. Jana Pawla II w Sosnowcu Sp. z o.o.
  • WIP Warsaw IBD Point Profesor Kierkus
  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory ReicherRecruiting
  • Clinic of FSBEI HE BSMU MoH RF
  • Federal State Budgetary Scientific Institution "Scientific and Research Rheumatology
  • Narodny ustav detskych chorob, Detska klinika LF UK a NUDCH
  • Detska Fakultna nemocnica Kosice
  • Narodny ustav reumatickych chorob
  • Emmed Research
  • Enhancing Care FoundationRecruiting
  • Enhancing Care FoundationRecruiting
  • Panorama Medical CentreRecruiting
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario y Politecnico La FeRecruiting
  • Hacettepe University Medical Faculty
  • Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi Clinical Research Center
  • Umraniye Training and Research Hospital
  • Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital Department of Pediatric Rheumatology
  • Erciyes Universitesi Tip Fakultesi Hastanesi
  • Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.
  • Municipal non-Profit Enterprise
  • CNE of Lviv Regional Council "Western Ukrainian Specialized Pediatric
  • Vinnytsia Regional Children's Clinical Hospital
  • NHS Greater Glasgow and Clyde, Royal Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tofacitinib 5 mg BID

Placebo

Arm Description

oral, twice daily, tablet or solution.

Outcomes

Primary Outcome Measures

Time to flare
Time to sJIA disease flare in the double-blind phase

Secondary Outcome Measures

Occurrence of disease flare in double-blind phase
disease flare frequency by visit in the double-blind phase.
Achievement of corticosteroid tapering at the end of the open-label phase
Rate of successful corticosteroid tapering.
Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment period
Adapted sJIA ACR 30/50/70/90/100 response at every visit from Day 7 onward in the open label and double blind phase.
Fever (Temp >38 Degrees Celsius) attributed to sJIA at Day 3, Day 7 and Day 14 of the open label phase.
CRP ≤ 10 mg/L at every visit of the open label phase.
"Absence of fever", defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phase.
Time to first Adapted JIA ACR 30 response in Part 1 of the open label phase.
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS 27) at every visit from Day 7 onward in the open label and double blind phase.
Change from baseline in each JIA ACR core variable at every visit from Day 7 onward in the open label and double blind phase.
Change from baseline in Child Health Questionnaire (CHQ) responses at the end of Part 1 and Part 2 of the open label phase, at randomization and every 3 months thereafter.
Change from baseline in Child Health Assessment Questionnaire (CHAQ) at every visit from Day 7 onward in the open label and double blind phase.
Occurrence of inactive disease status and minimal disease activity clinical remission at every visit from Day 7 onward (JADAS 27) in the open label and double blind phase.
Occurrence of inactive disease status and clinical remission at every visit from Day 7 onward (JIA ACR) in the open label and double blind phase.

Full Information

First Posted
November 9, 2016
Last Updated
September 1, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03000439
Brief Title
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
Official Title
EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
March 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. Once 31 flares are reported the study will be completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Juvenile Idiopathic
Keywords
systemic Juvenile Idiopathic Arthritis, Xeljanz, Tofacitinib, sJIA, CP-690 550

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tofacitinib 5 mg BID
Arm Type
Experimental
Arm Description
oral, twice daily, tablet or solution.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
In open-label phase: treatment with tofacitinib
Other Intervention Name(s)
CP-690,550, Xeljanz
Intervention Description
Treatment with investigational drug
Intervention Type
Drug
Intervention Name(s)
In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Other Intervention Name(s)
CP-690,550, Xeljanz
Intervention Description
Treatment with investigational drug or placebo
Primary Outcome Measure Information:
Title
Time to flare
Description
Time to sJIA disease flare in the double-blind phase
Time Frame
Up to 82 weeks after randomization
Secondary Outcome Measure Information:
Title
Occurrence of disease flare in double-blind phase
Description
disease flare frequency by visit in the double-blind phase.
Time Frame
Up to 82 weeks after randomization
Title
Achievement of corticosteroid tapering at the end of the open-label phase
Description
Rate of successful corticosteroid tapering.
Time Frame
12 to 40 weeks
Title
Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment period
Time Frame
12 to 40 weeks
Title
Adapted sJIA ACR 30/50/70/90/100 response at every visit from Day 7 onward in the open label and double blind phase.
Time Frame
Up to 82 weeks after randomization
Title
Fever (Temp >38 Degrees Celsius) attributed to sJIA at Day 3, Day 7 and Day 14 of the open label phase.
Time Frame
Day 3, Day 7, Day 14
Title
CRP ≤ 10 mg/L at every visit of the open label phase.
Time Frame
12 to 40 weeks
Title
"Absence of fever", defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phase.
Time Frame
Up to 82 weeks after randomization.
Title
Time to first Adapted JIA ACR 30 response in Part 1 of the open label phase.
Time Frame
12 to 40 weeks
Title
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS 27) at every visit from Day 7 onward in the open label and double blind phase.
Time Frame
Up to 82 weeks after randomization.
Title
Change from baseline in each JIA ACR core variable at every visit from Day 7 onward in the open label and double blind phase.
Time Frame
Up to 82 weeks after randomization.
Title
Change from baseline in Child Health Questionnaire (CHQ) responses at the end of Part 1 and Part 2 of the open label phase, at randomization and every 3 months thereafter.
Time Frame
Up to 82 weeks after randomization.
Title
Change from baseline in Child Health Assessment Questionnaire (CHAQ) at every visit from Day 7 onward in the open label and double blind phase.
Time Frame
Up to 82 weeks after randomization.
Title
Occurrence of inactive disease status and minimal disease activity clinical remission at every visit from Day 7 onward (JADAS 27) in the open label and double blind phase.
Time Frame
Up to 82 weeks after randomization.
Title
Occurrence of inactive disease status and clinical remission at every visit from Day 7 onward (JIA ACR) in the open label and double blind phase.
Time Frame
Up to 82 weeks after randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: active sJIA disease according to ILAR criteria before screening and at baseline (Day 1); 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: Previous juvenile idiopathic arthritis (JIA) treatment with tofacitinib. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
AdventHealth
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
AdventHealth Pediatric Outpatient Procedures and Sedation
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
AHMG Pediatric Rheumatology and Immunology
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
All Children's Hospital Specialty Physicians
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
AU Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Lurie Rheumatology Offices
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cohen Children's Medical Center of New York
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cohen Children's Medical Center of New York
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UNC Children's Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UNC Clinical & Translational Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UNC Children's Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cincinnati Children's Hospital Medical Center Investigational Drug Service
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Randall Children's Hospital at Legacy Emanuel
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Name
PPD Sample Management Department (PK Laboratory)
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Instituto CAICI SRL
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
S2000PBJ
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Hopital Universitaire des Enfants Reine Fabiola (HUDERF)
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP
City
Botucatu
State/Province
SAO Paulo
ZIP/Postal Code
18618-970
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Clinicas da UNICAMP
City
Campinas
State/Province
SAO Paulo
ZIP/Postal Code
13083-888
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Faculdade de Medicina da UNESP
City
Botucatu
State/Province
SÃO Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Individual Site Status
Recruiting
Facility Name
SPDM - Associacao Paulista para o Desenvolvimento da Medicina
City
Sao Paulo
ZIP/Postal Code
04024-002
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
SPDM - Associacao Paulista para o Desenvolvimento da Medicina
City
Sao Paulo
ZIP/Postal Code
04037-002
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto da Crianca do Hospital das Clinicas da FMUSP
City
Sao Paulo
ZIP/Postal Code
05409-011
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Alberta Children's Hospital/University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
McGill University Health Center, Glen Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Institute of McGill University Health Center, Glen site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Québec - Université Laval, Site CHUL
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
401122
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510623
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215003
Country
China
Individual Site Status
Recruiting
Facility Name
Xi'an Children's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710003
Country
China
Individual Site Status
Recruiting
Facility Name
Chengdu Women's and Children's Central Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610073
Country
China
Individual Site Status
Recruiting
Facility Name
The Children's Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310057
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Children's Hospital, Capital Medical University/Rheumatology Department
City
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hospital Metropolitano
City
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Active, not recruiting
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
HELIOS Kliniken Berlin Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
HELIOS Klinikum Berlin Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Gesundheit Nord gGmbH
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Deutsches Zentrum für Kinder- und Jugendrheumatologie
City
Garmisch-partenkirchen
ZIP/Postal Code
82467
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Asklepios Klinik Sankt Augustin GmbH, Zentrum für Allgemeine Pädiatrie und Neonatologie
City
Sankt Augustin
ZIP/Postal Code
53757
Country
Germany
Individual Site Status
Recruiting
Facility Name
St. Josef-Stift Sendenhorst
City
Sendenhorst
ZIP/Postal Code
48324
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Nirmal Hospital Pvt Ltd
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Recruiting
Facility Name
Sir Ganga Ram Hospital
City
Rajinder Nagar
State/Province
NEW Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Name
Institute of Child Health
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700017
Country
India
Individual Site Status
Recruiting
Facility Name
Institute of Post Graduate Medical Education and Research & SSKM Hospital
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700020
Country
India
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center - Pediatric Clinic
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center- Pharmacy
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Istituto Giannina Gaslini Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico
City
Genova
State/Province
Genoa
ZIP/Postal Code
16147
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Clínica de Investigacion en Reumatologia y Obesidad, S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
91-738
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Pediatrii im. Jana Pawla II w Sosnowcu Sp. z o.o.
City
Sosnowiec
ZIP/Postal Code
41-218
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warsaw
ZIP/Postal Code
00-728
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinic of FSBEI HE BSMU MoH RF
City
Ufa
State/Province
Republic OF Bashkortostan
ZIP/Postal Code
450083
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Federal State Budgetary Scientific Institution "Scientific and Research Rheumatology
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Narodny ustav detskych chorob, Detska klinika LF UK a NUDCH
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Detska Fakultna nemocnica Kosice
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Narodny ustav reumatickych chorob
City
Piestany
ZIP/Postal Code
921 12
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Emmed Research
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Enhancing Care Foundation
City
Durban
State/Province
Kwazulu-natal
ZIP/Postal Code
4301
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Enhancing Care Foundation
City
Durban
State/Province
Kwazulu-natal
ZIP/Postal Code
4302
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Panorama Medical Centre
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi Clinical Research Center
City
Fatih / Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Umraniye Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34764
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital Department of Pediatric Rheumatology
City
Kadikoy / Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Erciyes Universitesi Tip Fakultesi Hastanesi
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.
City
Dnipro
ZIP/Postal Code
49006
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Municipal non-Profit Enterprise
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
CNE of Lviv Regional Council "Western Ukrainian Specialized Pediatric
City
Lviv
ZIP/Postal Code
79035
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Vinnytsia Regional Children's Clinical Hospital
City
Vinnytsia
ZIP/Postal Code
21000
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
NHS Greater Glasgow and Clyde, Royal Hospital for Children
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=A3921165
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

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