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%
References (36)
- et al.
Pathogenesis and management of pain in osteoarthritis
Lancet
(2005) - et al.
OARSI recommendations for the management of hip and knee osteoarthritisPart I: Critical appraisal of existing treatment guidelines and systematic review of current research evidence
Osteoarthritis Cartilage
(2007) - et al.
Potential mechanism of action of intra-articular hyaluronan therapy in osteoarthritis: are the effects molecular weight dependent?
Semin Arthritis Rheum
(2002) - et al.
A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee
Osteoarthritis Cartilage
(2006) - et al.
OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited
Osteoarthritis Cartilage
(2004) - et al.
Intra-articular therapy in osteoarthritis
Baillieres Clin Rheumatol
(1997) - et al.
A systematic review of randomised controlled trials of pharmacological therapy in osteoarthritis of the knee, with emphasis on trial methodology
Semin Arthritis Rheum
(1997) - et al.
Viscosupplementation for the treatment of osteoarthritis of the knee
Cochrane Database Syst Rev
(2005) - et al.
Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States
Arthritis Rheum
(1998) The facts about arthritis
Prevalence of disabilities and associated health conditions among adults: United States, 1999
MMWR Morb Mortal Wkly Rep
Who is your customer?
License! June
Population projections. 2004
Viscosupplementation with hyaluronans for osteoarthritis of the knee: clinical efficacy and economic implications
Drugs Aging
Hyaluronan (HA) fragments induce chemokine gene expression in alveolar macrophagesThe role of HA size and CD44
J Clin Invest
Regulation of lung injury and repair by Toll-like receptors with hyaluronan
Nat Med
Inflammatory and immunological responses to hyaluronan preparationsStudy of a murine biocompatibility model
J Bone Joint Surg
[Experimental knee pain model in rats and analgesic effect of sodium hyaluronate (SPH)]
Nippon Yakurigaku Zasshi
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This study was supported by Ferring Pharmaceuticals Inc., Parsippany, New Jersey.