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Long-Term Safety Study Of Tofacinib In Patients With Juvenile Idiopathic Arthritis

Last updated on April 8, 2019

FOR MORE INFORMATION
Study Location
Phoenix Children's Hospital- Inpatient Pharmacy
Phoenix, Arizona, 85016 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Juvenile Idiopathic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-18 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria
for the qualifying/index study and in the opinion of the investigator have sufficient
evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects
turning 18 years of age during participation in the qualifying/index study or
subsequently will be eligible for participation in this study.

- The subject has discontinued disallowed concomitant medications for the required time
prior to the first dose of study drug, as defined in Appendix 1, and is taking only
those concomitant medications in doses and frequency allowed by the protocol.

- Fertile male subjects and female subjects of childbearing potential who are, in the
opinion of the investigator, sexually active and at risk for pregnancy with their
partner(s) must be using a highly effective method of contraception as outlined in
this protocol throughout the study and for at least 28 days after the last dose of
study medication.

- Subjects must have previously completed participation in a qualifying study of
tofacitinib for the treatment of JIA. Subjects who have required earlier
discontinuation of treatment in a qualifying study for reasons other than tofacitinib
related serious adverse events may be eligible.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Systemic JIA (sJIA) with active systemic features other than active joints and
elevated acute phase reactants, persistent oligoarthritis, and undifferentiated JIA.

- Infections:

1. Chronic infections.

2. Any infection requiring hospitalization, parenteral antimicrobial therapy or
judged to be opportunistic by the investigator within the 6 months prior to the
first dose of study drug.

3. Any treated infections within 2 weeks of baseline visit.

4. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis
B or hepatitis C virus.

5. History of infected joint prosthesis with prosthesis still in situ.

- History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.

NCT01500551
Pfizer
Recruiting
Long-Term Safety Study Of Tofacinib In Patients With Juvenile Idiopathic Arthritis

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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