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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03000439
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Belgium, Brazil, Canada, China, Costa Rica, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis Juvenile Idiopathic
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Tofacitinib 5 mg BID

oral, twice daily, tablet or solution.

Placebo Comparator: Placebo

Interventions

Drug: - In open-label phase: treatment with tofacitinib

Treatment with investigational drug

Drug: - In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio

Treatment with investigational drug or placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix Children's Hospital, Phoenix, Arizona

Status

Not yet recruiting

Address

Phoenix Children's Hospital

Phoenix, Arizona, 85016

Children's Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Children's National Medical Center, Washington, District of Columbia

Status

Not yet recruiting

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Saint Petersburg, Florida

Status

Not yet recruiting

Address

All Children's Hospital Specialty Physicians

Saint Petersburg, Florida, 33701

Chicago, Illinois

Status

Recruiting

Address

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

Children's Mercy Hospital, Kansas City, Missouri

Status

Not yet recruiting

Address

Children's Mercy Hospital

Kansas City, Missouri, 64108

Hackensack University Medical Center, Hackensack, New Jersey

Status

Not yet recruiting

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Lake Success, New York

Status

Recruiting

Address

Cohen Children's Medical Center of New York

Lake Success, New York, 11042

New Hyde Park, New York

Status

Recruiting

Address

Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040

Hospital for Special Surgery, New York, New York

Status

Not yet recruiting

Address

Hospital for Special Surgery

New York, New York, 10021

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center Investigational Drug Service

Cincinnati, Ohio, 45229

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Oklahoma City, Oklahoma

Status

Not yet recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Portland, Oregon

Status

Recruiting

Address

Randall Children's Hospital at Legacy Emanuel

Portland, Oregon, 97227

International Sites

Instituto CAICI SRL, Rosario, Santa FE, Argentina

Status

Recruiting

Address

Instituto CAICI SRL

Rosario, Santa FE, S2000PBJ

Centro Medico Privado de Reumatologia, San Miguel de Tucuman, Tucuman, Argentina

Status

Recruiting

Address

Centro Medico Privado de Reumatologia

San Miguel de Tucuman, Tucuman, T4000AXL

Brussels, Belgium

Status

Not yet recruiting

Address

Hopital Universitaire des Enfants Reine Fabiola (HUDERF)

Brussels, , 1020

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Gent

Gent, , 9000

Hospital de Clínicas de Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil

Status

Not yet recruiting

Address

Hospital de Clínicas de Porto Alegre

Porto Alegre, RIO Grande DO SUL, 90035-903

Botucatu, SAO Paulo, Brazil

Status

Recruiting

Address

UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP

Botucatu, SAO Paulo, 18618-970

Hospital de Clinicas da UNICAMP, Campinas, SAO Paulo, Brazil

Status

Not yet recruiting

Address

Hospital de Clinicas da UNICAMP

Campinas, SAO Paulo, 13083-888

Faculdade de Medicina da UNESP, Botucatu, SÃO Paulo, Brazil

Status

Recruiting

Address

Faculdade de Medicina da UNESP

Botucatu, SÃO Paulo, 18618-686

Sao Paulo, Brazil

Status

Recruiting

Address

SPDM - Associacao Paulista para o Desenvolvimento da Medicina

Sao Paulo, , 04024-002

Sao Paulo, Brazil

Status

Recruiting

Address

SPDM - Associacao Paulista para o Desenvolvimento da Medicina

Sao Paulo, , 04037-002

Sao Paulo, Brazil

Status

Not yet recruiting

Address

Instituto da Crianca do Hospital das Clinicas da FMUSP

Sao Paulo, , 05409-011

Calgary, Alberta, Canada

Status

Not yet recruiting

Address

Alberta Children's Hospital/University of Calgary

Calgary, Alberta, T3B 6A8

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Montreal, Quebec, Canada

Status

Recruiting

Address

McGill University Health Center, Glen Site

Montreal, Quebec, H4A 3J1

Montreal, Quebec, Canada

Status

Recruiting

Address

Research Institute of McGill University Health Center, Glen site

Montreal, Quebec, H4A 3J1

Chongqing, Chongqing, China

Status

Recruiting

Address

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing, 401122

Suzhou, Jiangsu, China

Status

Recruiting

Address

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215003

Xi'an Children's Hospital, Xi'an, Shaanxi, China

Status

Recruiting

Address

Xi'an Children's Hospital

Xi'an, Shaanxi, 710003

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003

Beijing, China

Status

Recruiting

Address

Beijing Children's Hospital, Capital Medical University/Rheumatology Department

Beijing, , 100045

Children's Hospital of Fudan University, Shanghai, China

Status

Not yet recruiting

Address

Children's Hospital of Fudan University

Shanghai, , 201102

Hospital Metropolitano, San Jose, Costa Rica

Status

Recruiting

Address

Hospital Metropolitano

San Jose, , 10103

Berlin, Germany

Status

Not yet recruiting

Address

Charite - Universitaetsmedizin Berlin, Campus Virchow

Berlin, , 13353

Gesundheit Nord gGmbH, Bremen, Germany

Status

Not yet recruiting

Address

Gesundheit Nord gGmbH

Bremen, , 28177

Garmisch-partenkirchen, Germany

Status

Not yet recruiting

Address

Deutsches Zentrum für Kinder- und Jugendrheumatologie

Garmisch-partenkirchen, , 82467

Sankt Augustin, Germany

Status

Not yet recruiting

Address

Asklepios Klinik Sankt Augustin GmbH, Zentrum für Allgemeine Pädiatrie und Neonatologie

Sankt Augustin, , 53757

St. Josef-Stift Sendenhorst, Sendenhorst, Germany

Status

Recruiting

Address

St. Josef-Stift Sendenhorst

Sendenhorst, , 48324

Semmelweis Egyetem, Budapest, Hungary

Status

Not yet recruiting

Address

Semmelweis Egyetem

Budapest, , 1094

Nirmal Hospital Pvt Ltd, Surat, Gujarat, India

Status

Recruiting

Address

Nirmal Hospital Pvt Ltd

Surat, Gujarat, 395002

Sir Ganga Ram Hospital, Rajinder Nagar, NEW Delhi, India

Status

Not yet recruiting

Address

Sir Ganga Ram Hospital

Rajinder Nagar, NEW Delhi, 110060

Institute of Child Health, Kolkata, WEST Bengal, India

Status

Recruiting

Address

Institute of Child Health

Kolkata, WEST Bengal, 700017

Kolkata, WEST Bengal, India

Status

Recruiting

Address

Institute of Post Graduate Medical Education and Research & SSKM Hospital

Kolkata, WEST Bengal, 700020

Rambam Health Care Campus, Haifa, Israel

Status

Not yet recruiting

Address

Rambam Health Care Campus

Haifa, , 3109601

Meir Medical Center - Pediatric Clinic, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center - Pediatric Clinic

Kfar Saba, , 4428164

Meir Medical Center- Pharmacy, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center- Pharmacy

Kfar Saba, , 4428164

Genova, Genoa, Italy

Status

Recruiting

Address

Istituto Giannina Gaslini Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico

Genova, Genoa, 16147

Milano, Milan, Italy

Status

Recruiting

Address

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Milan, 20122

Guadalajara, Jalisco, Mexico

Status

Recruiting

Address

Clínica de Investigacion en Reumatologia y Obesidad, S.C.

Guadalajara, Jalisco, 44650

Monterrey, Nuevo LEON, Mexico

Status

Recruiting

Address

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo LEON, 64460

San Luis Potosi, Mexico

Status

Not yet recruiting

Address

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.

San Luis Potosi, , 78213

UMC Utrecht, Wilhelmina kinderziekenhuis, Utrecht, Netherlands

Status

Not yet recruiting

Address

UMC Utrecht, Wilhelmina kinderziekenhuis

Utrecht, , 3584 EA

Krakow, Poland

Status

Not yet recruiting

Address

Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie

Krakow, , 31-503

Lodz, Poland

Status

Not yet recruiting

Address

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, , 91-738

Sosnowiec, Poland

Status

Not yet recruiting

Address

Centrum Pediatrii im. Jana Pawla II w Sosnowcu Sp. z o.o.

Sosnowiec, , 41-218

Warszawa, Poland

Status

Recruiting

Address

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

Warszawa, , 02-637

Clinic of FSBEI HE BSMU MoH RF, Ufa, Republic OF Bashkortostan, Russian Federation

Status

Active, not recruiting

Address

Clinic of FSBEI HE BSMU MoH RF

Ufa, Republic OF Bashkortostan, 450083

SAHI CRCH MoH TR, Kazan, Russian Federation

Status

Not yet recruiting

Address

SAHI CRCH MoH TR

Kazan, , 420138

Moscow, Russian Federation

Status

Active, not recruiting

Address

Federal State Budgetary Scientific Institution "Scientific and Research Rheumatology

Moscow, , 115522

Saratov, Russian Federation

Status

Not yet recruiting

Address

Clinical Hospital n. a. S.R. Mirotvortsev of Saratov SMU

Saratov, , 410054

Bratislava, Slovakia

Status

Not yet recruiting

Address

Narodny ustav detskych chorob, Detska klinika LF UK a NUDCH

Bratislava, , 833 40

Detska Fakultna nemocnica Kosice, Kosice, Slovakia

Status

Not yet recruiting

Address

Detska Fakultna nemocnica Kosice

Kosice, , 04011

Narodny ustav reumatickych chorob, Piestany, Slovakia

Status

Not yet recruiting

Address

Narodny ustav reumatickych chorob

Piestany, , 921 12

Emmed Research, Pretoria, Gauteng, South Africa

Status

Not yet recruiting

Address

Emmed Research

Pretoria, Gauteng, 0002

Enhancing Care Foundation, Durban, Kwazulu-natal, South Africa

Status

Recruiting

Address

Enhancing Care Foundation

Durban, Kwazulu-natal, 4091

Panorama Medical Centre, Cape Town, Western CAPE, South Africa

Status

Recruiting

Address

Panorama Medical Centre

Cape Town, Western CAPE, 7500

Hospital Universitario Ramon y Cajal, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario Ramon y Cajal

Madrid, , 28034

Hospital Universitario La Paz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz

Madrid, , 28046

Valencia, Spain

Status

Recruiting

Address

Hospital Universitario y Politecnico La Fe

Valencia, , 46026

Hacettepe University Medical Faculty, Ankara, Turkey

Status

Not yet recruiting

Address

Hacettepe University Medical Faculty

Ankara, , 06100

Fatih / Istanbul, Turkey

Status

Not yet recruiting

Address

Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi Clinical Research Center

Fatih / Istanbul, , 34098

Umraniye Training and Research Hospital, Istanbul, Turkey

Status

Not yet recruiting

Address

Umraniye Training and Research Hospital

Istanbul, , 34764

Kadikoy / Istanbul, Turkey

Status

Recruiting

Address

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital Department of Pediatric Rheumatology

Kadikoy / Istanbul, , 34722

Kayseri, Turkey

Status

Not yet recruiting

Address

Erciyes Universitesi Tip Fakultesi Hastanesi

Kayseri, , 38039

Dnipro, Ukraine

Status

Active, not recruiting

Address

Communal Institution "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.

Dnipro, , 49006

Municipal non-Profit Enterprise, Ivano-Frankivsk, Ukraine

Status

Active, not recruiting

Address

Municipal non-Profit Enterprise

Ivano-Frankivsk, , 76014

Lviv, Ukraine

Status

Terminated

Address

CNE of Lviv Regional Council "Western Ukrainian Specialized Pediatric

Lviv, , 79035

Vinnytsia, Ukraine

Status

Active, not recruiting

Address

Vinnytsia Regional Children's Clinical Hospital

Vinnytsia, , 21000

Glasgow, United Kingdom

Status

Not yet recruiting

Address

NHS Greater Glasgow and Clyde, Royal Hospital for Children

Glasgow, , G51 4TF