Phase 4
Completed N=198
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Arthritis, Juvenile Rheumatoid
Source: ClinicalTrials.gov NCT00807846 ↗
Enrolled (actual)
198
Serious AEs
0.5%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit — 0.366; -0.734 mmHg (millimeter of mercury) — p=0.274
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit |
0.366; -0.734 | 0.274 |
| SECONDARY Change From Baseline to Week 2 in SBP. |
-0.202; -1.290 | 0.148 |
| SECONDARY Change From Baseline in SBP at Week 4. |
-0.170; -2.007 | 0.027 sig |
| SECONDARY Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. |
-1.346; -0.139 | 0.106 |
| SECONDARY Change From Baseline in DBP at Week 4. |
-0.628; -0.848 | 0.776 |
| SECONDARY Change From Baseline in DBP at Week 6/Final Visit |
-0.535; -0.356 | 0.815 |
| SECONDARY Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit. |
-10.581; -13.614 | 0.303 |
| SECONDARY Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit. |
47; 54 | 0.392 |
| SECONDARY Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. |
-12.990; -12.588 | 0.897 |
| SECONDARY Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit. |
33; 45 | 0.200 |
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
Data sourced from ClinicalTrials.gov (NCT00807846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.