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

Viatris

Status and phase

Completed

Phase 4

Conditions

Arthritis, Juvenile Rheumatoid

Treatments

Drug: Celecoxib

Drug: Naproxen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00807846

A3191342

Details and patient eligibility

About

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

Enrollment

201 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

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