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.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.39 sites in 10 countries201 target enrollmentSeptember 2009

ConditionsArthritis, Juvenile Rheumatoid

InterventionsCelecoxib Naproxen

DrugsCelecoxib Naproxen

Overview

Phase: Phase 4
Intervention: Celecoxib
Conditions: Arthritis, Juvenile Rheumatoid
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 201
Locations: 39
Primary Endpoint: Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

December 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Celecoxib

Intervention: Celecoxib

Naproxen

Intervention: Naproxen

Outcomes

Primary Outcomes

Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit

Time Frame: 6 Weeks/Final Visit

Value at 6 weeks minus value at baseline.

Secondary Outcomes

Change From Baseline in SBP at Week 4.(4 weeks)
Change From Baseline to Week 2 in SBP.(2 weeks)
Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.(Week 6/Final Visit)
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.(2 weeks)
Change From Baseline in DBP at Week 4.(4 weeks)
Change From Baseline in DBP at Week 6/Final Visit(6 weeks)
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.(Week 6/Final Visit)
Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.(6 weeks)
Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.(6 weeks)