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



Status:Recruiting
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:2 - 18
Updated:4/6/2019
Start Date:March 18, 2013
End Date:March 31, 2021
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have
previously participated in tofacitinib JIA studies.

This is a Phase 2/3, long term, open‑label, follow‑up study. Subjects will have previously
participated in qualifying/index JIA studies of tofacitinib. Those who have already completed
such participation and enroll outside the 14 day window following completion of the End of
Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to
determine eligibility. A Baseline Visit will then occur within 28 days after the Screening
Visit. For subjects who are completing participation in a qualifying study of tofacitinib and
enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of
the qualifying/index study can be combined with the Screening and Baseline Visits for this
study. The subjects who enroll within the 14 day window following completion of the EOS Visit
of the qualifying/index study will participate in a combined Screening and Baseline Visit for
this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3
months, then every 3 months thereafter as long as the subject remains in the study.

Approximately 340 participants are projected to enroll into this open label extension study
after completing a qualifying/index study in the JIA program.

This study (A3921145) is planned to run until the first global marketing approval of
tofacitinib for the treatment of JIA. The total duration of an individual subject's
participation may vary depending upon when they enter the trial.

Inclusion Criteria:

- 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:

- 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.
We found this trial at
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4501 Cameron Valley Parkway
Charlotte, North Carolina 28211
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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2040 Ridgewood Drive Northeast
Atlanta, Georgia 30322
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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2015 Uppergate Drive
Atlanta, Georgia 30322
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Augusta, Georgia 30912
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314 East 204th Street
Bronx, New York 10467
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74 Perdriel
Caba, Buenos Aires C1280
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1001 Blythe Boulevard
Charlotte, North Carolina 28203
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Charlotte, North Carolina 28203
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1628 East Morehead Street
Charlotte, North Carolina 28207
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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282 Washington Street
Hartford, Connecticut 06106
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Indianapolis, Indiana 46202
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Lake Success, New York 11042
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Loma Linda, California 92354
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11234 Anderson Street
Loma Linda, California 92354
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Loma Linda, California 92354
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4616 De Longpre Avenue
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Miami, Florida 33155
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New Hyde Park, New York 11040
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New York, New York 10032
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1919 East Thomas Road
Phoenix, Arizona 85016
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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100 Mario Capecchi Drive
Salt Lake City, Utah 84113
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Salt Lake City, Utah 84143
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San Diego, California 92123
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington, District of Columbia 20010
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