CLASS clarification: reaffirms the medical importance of the analyses and resultsBMJ 2003; 327 doi: https://doi.org/10.1136/bmjusa.02090004 (Published 19 November 2003) Cite this as: BMJ 2003;327:E143
- G Steven Geis, group vice president, clinical research (firstname.lastname@example.org)
- Pharmacia 5200 Old Orchard Rd Skokie, IL 60077
- Correspondence to: G S Geis
From BMJ USA 2002;September:522
We appreciate the opportunity to correct the inaccuracies in the article by Jüni et al,1 which appear to be based on an incomplete understanding of the CLASS design, data, and statistical issues. Contrary to the editorial's assertions, there were no post hoc changes in the study design or the outcome definitions. The CLASS authors reviewed all the data and decided the 6-month analyses were most appropriate for initial publication,2 while the FDA chose 9-month data as most appropriate for a recent label change.3 Despite differing medical judgment for the time interval that best reflected the data, and contrary to the BMJ editorial allegations, the conclusions were similar.
CLASS was a single study with the objective of comparing the rate of ulcer complications with celecoxib versus traditional NSAIDs. The need for two protocols was prespecified to ensure blinding of study medications. One protocol included celecoxib 400 mg BID and ibuprofen 800 mg TID; the other included celecoxib 400 mg BID and diclofenac 75 mg BID. Aside from this difference and the inclusion of quality of life measures in one protocol, the protocols were …