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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Arthritis, Juvenile Rheumatoid

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Naproxen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br> | Drug: Celecoxib<br>* Celecoxib 50 mg or 100 mg PO BID for 6 weeks<br>|
| Experimental: Naproxen<br> | Drug: Naproxen<br>* Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit | Value at 6 weeks minus value at baseline. | 6 Weeks/Final Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in DBP at Week 6/Final Visit | Value at 6 weeks/Final Visit minus value at baseline. | 6 weeks | 
| Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit. | The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor. | 6 weeks | 
| Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit. | The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor. | Week 6/Final Visit | 
| Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. | Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'. | 6 weeks | 
| Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit. | Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'. | Week 6/Final Visit | 
| Change From Baseline to Week 2 in SBP. | Value at 2 weeks minus value at baseline. | 2 weeks | 
| Change From Baseline in SBP at Week 4. | Value at 4 weeks minus value at baseline. | 4 weeks | 
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. | Value at 2 weeks minus value at baseline. | 2 weeks | 
| Change From Baseline in DBP at Week 4. | Value at 4 weeks minus value at baseline. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis