Date: 2015-04-17
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Anika Therapeutics (USA – MA)
Product: Cingal® (cross-linked sodium hyaluronate combined with triamcinolone hexacetonide)
Action
mechanism: Cingal combines the cross-linked hyaluronic acid formulation of Monovisc®, approved to provide long-term relief of the symptoms of OA, with an FDA-approved steroid to provide additional short-term pain relief.
Disease: symptomatic relief of osteoarthritis (OA) of the knee
Therapeutic area: Rheumatic diseases
Country: Czech republic, Hungary, Poland
Trial
details: Cingal 13-02 is an open-label, follow-on study to Cingal 13-01 to evaluate the safety of a repeat injection of cross-linked sodium hyaluronate combined with triamcinolone hexacetonide (Cingal®) to provide symptomatic relief of osteoarthritis of the knee.(NCT02381652)
Latest
news: * On April 17, 2015, Anika Therapeutics announced the completion of enrollment in the Cingal 13-02 study, an open-label, follow-on study to the Cingal 13-01 study, to evaluate the safety of a repeat injection of cross-linked sodium hyaluronate combined with triamcinolone hexacetonide (Cingal®) intended to provide symptomatic relief of osteoarthritis (OA) of the knee. A total of 242 subjects, all of whom participated in the Cingal 13-01 study, were enrolled and re-treated with an additional Cingal injection. Study results will be available mid-year, and they will be used to support labeling for repeat injections with Cingal.In the pivotal Cingal 13-01 study, 368 subjects were enrolled in a multicenter, randomized, double blind, saline-controlled study with an active comparator arm (Monovisc). The Cingal 13-01 study was conducted to investigate the safety and efficacy of Cingal in treating pain in patients with OA. The study results demonstrated that Cingal is statistically and clinically superior to saline with the data meeting the primary and all secondary endpoints. Adverse event rates were very low, evidencing the safety of the product.
In the Cingal 13-01 study, Cingal met the primary endpoint by demonstrating superiority over saline for the change in WOMAC Pain Score over baseline levels through 12 weeks after treatment in the Intent to Treat (ITT) population (-40.2 mm vs. -31.0 mm, p=0.0099). The benefits proved long lasting as Cingal delivered a 72% improvement (-42.4 mm, p < 0.01) in WOMAC Pain Score relative to baseline at 26 weeks after injection.
Cingal also met all secondary endpoints relative to saline in the ITT analysis. Over 92.0% of Cingal subjects met the definition of OMERACT-OARSI Responders through 26 Weeks (p=0.01 vs. saline). Global Assessments (Patient and Evaluator) show the strong clinical benefit of Cingal through 26 weeks, with improvements over saline of 10.6 mm and 9.1 mm respectively (p < 0.01). In addition to pain relief, endpoints measuring stiffness and physical function through 26 weeks support the superiority of Cingal compared with saline (p=0.01 and p=0.02, respectively). These study results were included in pre-marketing applications submitted in the United States and European Union, and they demonstrate that Anika\'s single injection HA viscosupplementation product, Monovisc, provides long-term pain relief and that the addition of the steroid provides a short-term, statistically-significant improvement in pain reduction during the first three weeks following treatment.
