A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:2 - 17
Updated:4/21/2016
Start Date:September 2009
End Date:December 2012

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A Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis.

This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib
(Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic
Arthritis


Inclusion Criteria:

- Polyarticular (both rheumatoid factor positive and rheumatoid factor
negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the
International League of Associations for Rheumatology (ILAR) criteria for Juvenile
Idiopathic Arthritis (JIA)

- Subjects with Systemic JIA with active arthritis in at least 1 joint but without
active systemic features are eligible

- ≥2 years of age and <18 years of age prior to the Baseline visit

- Body weight ≥10 kg at the Baseline visit

- Candidate for chronic NSAID therapy in the Investigator's judgment

Exclusion Criteria:

- Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis
types of JIA

- Active systemic features over the prior 12 weeks in children with systemic Juvenile
Idiopathic Arthritis (JIA)

- Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated
arthritis should be excluded

- Subjects with active Systemic JIA should not be enrolled
We found this trial at
19
sites
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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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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Hartford, CT
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231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Louisville, KY
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
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Delray Beach, Florida 33484
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Delray Beach, Florida 33484
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Hershey, Pennsylvania 17033
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Honolulu, HI
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Honolulu, HI
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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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Little Rock, AR
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Louisville, KY
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Omaha, Nebraska 68114
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San Diego, California 92123
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Santiago, RM 83804
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Santiago,
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Tucson, Arizona 85704
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Washington, District of Columbia 20010
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