OsteoarthritisA Double-Blind, Randomized, Saline-Controlled Study of the Efficacy and Safety of EUFLEXXA® for Treatment of Painful Osteoarthritis of the Knee, With an Open-Label Safety Extension (The FLEXX Trial)
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Subjects and Methods
The study was conducted in the United States from October 2006 to May 2008 in accordance with the International Conference on Harmonization Guidelines for Good Clinical Practice and the Declaration of Helsinki concerning medical research in humans. Subjects were enrolled at 36 sites. Criteria for inclusion were as follows: OA of the knee by American College of Rheumatology criteria (18); moderate to severe pain score of 41 to 90 mm recorded on 100-mm visual analog scale (VAS) immediately
Results
Subject disposition is reflected in Figure 1. To randomize 588 subjects (IA-BioHA n = 293, IA-SA = 295), 821 were screened. Overall, there was an 88% completion rate in each treatment group. There were no differences in demographics between those completing and those discontinuing the study. There were 34 discontinuations in each group. AE discontinuations included 6 in the IA-SA group and 11 in the IA-BioHA group. Protocol violations caused discontinuation in 6 (3 in each group). Two subjects
Discussion
Treatment with IA-BioHA was superior to IA-SA in reducing knee pain due to OA at 26 weeks. Secondary measurements were generally supportive of the primary outcome measurement. IA-BioHA was well tolerated, with no joint effusions.
It is of interest that 6 months following the series of 3 IA-BioHA injections, almost half (47%) the subjects were pain free (100-mm VAS of <20 mm based on 50-foot walk). This compares favorably with 39% pain free with IA-SA. The OARSI responder criteria require a 50%
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This study was supported by Ferring Pharmaceuticals Inc., Parsippany, New Jersey.