<?xml version='1.0' encoding='UTF-8'?><xml><records><record><source-app name="HighWire" version="7.x">Drupal-HighWire</source-app><ref-type name="Journal Article">17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Reiff, Andreas</style></author><author><style face="normal" font="default" size="100%">Lovell, Daniel J</style></author><author><style face="normal" font="default" size="100%">Adelsberg, Janet Van</style></author><author><style face="normal" font="default" size="100%">Kiss, Maria H B</style></author><author><style face="normal" font="default" size="100%">Goodman, Steven</style></author><author><style face="normal" font="default" size="100%">Zavaler, Manuel Ferrandiz</style></author><author><style face="normal" font="default" size="100%">Chen, Pei-Yun</style></author><author><style face="normal" font="default" size="100%">Bolognese, James A</style></author><author><style face="normal" font="default" size="100%">Cavanaugh, Paul</style></author><author><style face="normal" font="default" size="100%">Reicin, Alise S</style></author><author><style face="normal" font="default" size="100%">Giannini, Edward H</style></author></authors><secondary-authors></secondary-authors></contributors><titles><title><style face="normal" font="default" size="100%">Evaluation of the comparative efficacy and tolerability of rofecoxib and naproxen in children and adolescents with juvenile rheumatoid arthritis: a 12-week randomized controlled clinical trial with a 52-week open-label extension.</style></title><secondary-title><style face="normal" font="default" size="100%">The Journal of Rheumatology</style></secondary-title></titles><dates><year><style  face="normal" font="default" size="100%">2006</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2006-05-01 00:00:00</style></date></pub-dates></dates><pages><style  face="normal" font="default" size="100%">985-995</style></pages><volume><style face="normal" font="default" size="100%">33</style></volume><issue><style face="normal" font="default" size="100%">5</style></issue><abstract><style  face="normal" font="default" size="100%">OBJECTIVE: To compare the safety and efficacy of rofecoxib* to naproxen for the treatment of juvenile rheumatoid arthritis (JRA). METHODS: This was a 12-week, multicenter, randomized, double-blind, double-dummy, active comparator-controlled, non-inferiority study with a prespecified 52-week open-label active comparator-controlled extension. Children (ages 2-11 yrs) and adolescents (ages 12-17 yrs) received lower-dose (LD)-rofecoxib [0.3 mg/kg/day up to 12.5 mg/day (base study only)]; or higher-dose (HD)-rofecoxib (0.6 mg/kg/day up to 25 mg/day) or naproxen 15 mg/kg/day as oral suspensions. Adolescents received daily rofecoxib (LD) 12.5 (base study only) or (HD) 25 mg, or naproxen 15 mg/kg/day (maximum 1,000 mg/day) as tablets. The primary endpoint was the time-weighted average proportion of patients meeting the American College of Rheumatology Pediatric-30 (ACR Pedi 30) response criteria. A prespecified bound for the 95% confidence interval for the ratio of the percentage of ACR Pedi 30 responders was used to assess non-inferiority of treatment response between groups. Safety was assessed throughout the study. RESULTS: A total of 310 patients ages 2-17 years (181 (3/4) age 11) were randomized to receive LD-rofecoxib (N=109), HD-rofecoxib (N=100), or naproxen (N=101). The ACR Pedi 30 response rates following 12 weeks of treatment were 46.2%, 54.5%, and 55.1%, respectively. The relative rates of response compared to naproxen were 0.81 (95% CI 0.61, 1.07) and 0.98 (95% CI 0.76, 1.26) for LD- and HD-rofecoxib, respectively. Both rofecoxib doses were not inferior to naproxen. Patients (N=227) entering the extension received HD-rofecoxib or naproxen with efficacy maintained during the extension. All treatments were generally well tolerated throughout the study. CONCLUSION: Daily treatment of JRA patients with rofecoxib up to 12.5 or 25 mg was well tolerated, providing sustained clinical effectiveness comparable to naproxen 15 mg/kg. *On September 30, 2004, Merck &amp; Co., Inc. announced the voluntary worldwide withdrawal of rofecoxib from the market.</style></abstract></record></records></xml>