Status:
COMPLETED
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Arthritis, Juvenile Rheumatoid
Eligibility:
All Genders
2-17 years
Phase:
PHASE4
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00807846
Start Date
September 1 2009
End Date
December 1 2012
Last Update
February 2 2021
Active Locations (39)
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1
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, United States, 85704
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Children's Hospital-San Diego
San Diego, California, United States, 92123
4
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106