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Efficacy Study Of Tofacitinib In Pediatric JIA Population

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Arkansas Children's Hospital - Attention: Jill Hernandez
Little Rock, Arkansas, 72202 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
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Male or female aged 2 to 17 years.

2. Must have diagnosis of one of the following JIA subcategories:
◦Extended oligoarthritis;
◦Polyarthritis (RF+);
◦Polyarthritis (RF-);
◦Systemic JIA with active arthritis but without active systemic features in the prior 6 months and at the time of enrollment;
◦Psoriatic arthritis;
◦Enthesitis related arthritis.

3. Depending on JIA diagnosis, participants must have at minimum 3 to 5 active joints (an active joint is defined as a joint with swelling or, in the absence of swelling, limited range of motion accompanied by either pain on motion or tenderness).

4. Inadequate response or intolerance to at least one Disease Modifying Anti Rheumatic Drug (DMARD), which may include Methotrexate or biologic agents.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Active uveitis within 3 months of enrollment.

2. History of any other rheumatologic disease, other than Sjogren's syndrome.

3. Previously failed more than 3 biologic therapies (with different mechanisms of action) for JIA.

4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Liquid
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Duration
The time commitment for participation in the study.
Screening: Up to 4 weeks
Treatment: Up to 44 weeks
Site Visits
Screening: Estimated 3 visits
Treatment: Up to 13 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Possible
Trial Procedures
Blood test
Physical examination
Keeping a diary
Questionnaire
Urine test
Vital signs and measurements
NCT02592434
Pfizer
Recruiting
Efficacy Study Of Tofacitinib In Pediatric JIA Population

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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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