Abstract | OBJECTIVE: METHODS: An open label, multicenter study was conducted in children with JRA aged 2-16 years, weighing > 14 kg, and requiring nonsteroidal antiinflammatory drugs ( NSAID) for control of symptoms. NSAID were discontinued one day prior to study initiation to minimize disease flare. Patients received nabumetone 30 mg/kg once daily (as a tablet or a slurry) for 12 weeks. Efficacy assessment evaluations were performed at Weeks 1, 3, 6, and 12, based on the mean change from baseline at the study endpoint for 6 standard rheumatology variables. An overall assessment of efficacy was determined based on the percentage of patients who did not experience a flare, using the 6 rheumatology variables. Since this was an open label study, only descriptive statistics were obtained for efficacy variables. Routine safety assessments were completed for all patients. RESULTS: In total, 99 patients with JRA were enrolled and 89 completed the study; mean age was 9.2 years. The proportion of nabumetone treated patients with no flare in disease activity during the nabumetone treatment period was 92/99 (93%). Improvement was noted in each efficacy assessment, although statistical evaluations were not performed. The adverse event profile was similar to that reported for nabumetone in adults with RA. CONCLUSION:
Nabumetone 30 mg/kg/day (up to 2000 mg/day) demonstrated a safe profile with no loss of efficacy compared to previous treatment in children with JRA. The dose can be administered by suspending tablets in warm water to create a slurry.
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Authors | Steve Goodman, Paul Howard, Ann Haig, Susan Flavin, Brian Macdonald |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 30
Issue 4
Pg. 829-31
(Apr 2003)
ISSN: 0315-162X [Print] Canada |
PMID | 12672207
(Publication Type: Clinical Trial, Journal Article, Multicenter Study)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Butanones
- Tablets
- Nabumetone
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Topics |
- Adolescent
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects)
- Arthritis, Juvenile
(drug therapy)
- Butanones
(administration & dosage, adverse effects)
- Child
- Child, Preschool
- Female
- Humans
- Male
- Nabumetone
- Patient Compliance
- Tablets
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