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 for at least 6 weeks before screening - 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 JIA treatment with tofacitinib; - Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with sJIA.
Current symptoms or findings of more than minimal pleuritis with sJIA
  • - Subjects who have previously failed treatment with more than two biologic DMARDs.
Note: all subjects will be allowed to have previously failed one biologic DMARD, and up to forty (40) percent of subjects will be allowed to have previously failed two biologic DMARDs provided that washout periods are respected.

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, Brazil, Canada, Chile, China, Israel, Mexico, Russian Federation, South Africa, Turkey, Ukraine, 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

San Diego, California

Status

Recruiting

Address

Rady Children's Hospital Center for Pediatric Clinical Research

San Diego, California, 92123

San Diego, California

Status

Recruiting

Address

Rady Children's Hospital Rheumatology Clinic

San Diego, California, 92123

Rady Children's Hospital San Diego, San Diego, California

Status

Recruiting

Address

Rady Children's Hospital San Diego

San Diego, California, 92123

Saint Petersburg, Florida

Status

Not yet recruiting

Address

All Children's Hospital Specialty Physicians

Saint Petersburg, Florida, 33701

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

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

Portland, Oregon

Status

Recruiting

Address

Randall Children's Hospital at Legacy Emanuel

Portland, Oregon, 97227

Pittsburgh, Pennsylvania

Status

Not yet recruiting

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

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

Not yet recruiting

Address

Centro Medico Privado de Reumatologia

San Miguel de Tucuman, Tucuman, T4000AXL

Hospital Britanico de Buenos Aires, Caba, Argentina

Status

Not yet recruiting

Address

Hospital Britanico de Buenos Aires

Caba, , C1280AEB

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

Rio de Janeiro, Brazil

Status

Not yet recruiting

Address

Instituto de Puericultura e Pediatria Martagao Gesteira (IPPMG)

Rio de Janeiro, , 21941-912

Sao Paulo, Brazil

Status

Not yet recruiting

Address

SPDM - Associacao Paulista para o Desenvolvimento da Medicina

Sao Paulo, , 04024-002

Sao Paulo, Brazil

Status

Not yet 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

Bioreuma, Concepcion, Chile

Status

Recruiting

Address

Bioreuma

Concepcion, , 4070280

Chongqing, Chongqing, China

Status

Recruiting

Address

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing, 401122

Beijing, China

Status

Not yet recruiting

Address

Children's Hospital Affiliated to Capital Institute of Pediatrics/Rheumatology Immunology

Beijing, , 100020

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

Haifa, Israel

Status

Not yet recruiting

Address

Pediatrics B Ruth Rappaport children's hospital

Haifa, , 3109601

Rambam Health Care Campus - Pharmacy, Haifa, Israel

Status

Not yet recruiting

Address

Rambam Health Care Campus - Pharmacy

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

Guadalajara, Jalisco, Mexico

Status

Not yet recruiting

Address

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

Guadalajara, Jalisco, 44650

Monterrey, Nuevo LEON, Mexico

Status

Not yet 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

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

Status

Not yet 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

Recruiting

Address

Federal State Budgetary Scientific Institution "Scientific and Research Rheumatology

Moscow, , 115522

Moscow, Russian Federation

Status

Not yet recruiting

Address

FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),

Moscow, , 119435

FSAI NMRCCH MoH RF, Moscow, Russian Federation

Status

Not yet recruiting

Address

FSAI NMRCCH MoH RF

Moscow, , 119991

FSBEI HE SPbSPMU MoH RF, Saint Petersburg, Russian Federation

Status

Not yet recruiting

Address

FSBEI HE SPbSPMU MoH RF

Saint Petersburg, , 194100

Saratov, Russian Federation

Status

Not yet recruiting

Address

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

Saratov, , 410054

Yekaterinburg, Russian Federation

Status

Not yet recruiting

Address

State Budgetary Healthcare Institution of Sverdlovsk Region "Regional Children's Clinical Hospital

Yekaterinburg, , 620149

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

Not yet recruiting

Address

Enhancing Care Foundation

Durban, Kwazulu-natal, 4091

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

Status

Not yet recruiting

Address

Panorama Medical Centre

Cape Town, Western CAPE, 7500

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

Istanbul, Turkey

Status

Recruiting

Address

Istanbul Medeniyet University Medical Faculty

Istanbul, , 34000

Umraniye Training and Research Hospital, Istanbul, Turkey

Status

Not yet recruiting

Address

Umraniye Training and Research Hospital

Istanbul, , 34764

Kayseri, Turkey

Status

Not yet recruiting

Address

Erciyes Universitesi Tip Fakultesi Hastanesi

Kayseri, , 38039

Dnipro, Ukraine

Status

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

Recruiting

Address

Municipal non-Profit Enterprise

Ivano-Frankivsk, , 76014

Lviv, Ukraine

Status

Recruiting

Address

CNE of Lviv Regional Council "Western Ukrainian Specialized Pediatric

Lviv, , 79035

Vinnytsia, Ukraine

Status

Recruiting

Address

Vinnytsia Regional Children's Clinical Hospital

Vinnytsia, , 21000