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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Celecoxib; Naproxen

Criteria

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