A randomized, controlled, clinical trial of @entity14296 in the treatment of XXXX .

@entity1 @entity625 @entity1623 @entity158 @entity14296 @entity3840 @entity309
OBJECTIVE: To evaluate the efficacy and tolerability of the highly selective @entity3840 ( @entity3840 ) inhibitor @entity14296 for the treatment of @entity309 ( @entity309 ). METHODS: A double blind, randomized, placebo and active comparator controlled, 12 week study conducted at 88 US sites. Eligible @entity1 were chronic nonsteroidal antiinflammatory drug (NSAID) users with clinical worsening of @entity309 upon withdrawal of prestudy NSAID. @entity1 received either placebo, @entity14296 90 mg once daily, or @entity1623 500 mg twice daily (2:2:1 allocation ratio). Primary efficacy measures: @entity1 and investigator global assessments of disease activity and direct assessment of @entity625 by counts of tender and swollen joints. Key secondary measures: @entity1 global assessment of @entity158 , the Stanford Health Assessment Questionnaire, and the percentage of @entity1 both completing the study and meeting the ACR20 criteria. Tolerability was assessed by tabulation of adverse events and routine laboratory evaluations. RESULTS: In all, 816 @entity1 were randomized (placebo = 323, @entity14296 = 323, @entity1623 = 170), and 448 completed 12 weeks of treatment (placebo = 122, @entity14296 = 230, @entity1623 = 96). Compared with @entity1 receiving placebo, @entity1 receiving @entity14296 and @entity1623 showed significant improvements in all efficacy endpoints (p < 0.01). Compared with @entity1 receiving @entity1623 , @entity1 receiving @entity14296 demonstrated significant improvements (p < 0.05) on all primary endpoints and most other endpoints including ACR20 criteria. The percentage of @entity1 who achieved an ACR20 response and who completed the study was 21%, 53%, and 39% in the placebo, @entity14296 and @entity1623 groups, respectively. @entity14296 and @entity1623 were both generally well tolerated. CONCLUSION: In this study, @entity14296 90 mg once daily was more effective than either placebo or @entity1623 500 mg twice daily for treating @entity1 with @entity309 over 12 weeks. @entity14296 90 mg was generally well tolerated in @entity1 with @entity309 .
