مؤتمر
Safety and efficacy of intra-articular injection of JTA-004, a novel viscosupplement, in symptomatic knee osteoarthritis: a randomized, double-blind controlled phase II/III study
| العنوان: | Safety and efficacy of intra-articular injection of JTA-004, a novel viscosupplement, in symptomatic knee osteoarthritis: a randomized, double-blind controlled phase II/III study |
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| المؤلفون: | Bettonville, Marie, Delmarcelle, Anne-Sophie, Léon, Marc, Ster, Bogdan, Kaux, Jean-François, Appelboom, Thierry, Margaux, Joëlle, Urbin-Choffray, Didier, Theunissen, Emilie, Besse-Hammer, Tatiana, De Greift, Philippe, Qu, Jiangang, Fortems, Yves, Verlinden, Séverine, Godeaux, Olivier |
| المصدر: | 2nd World congress on Rheumatology and Orthopedics, Paris, France [FR], September 26-27, 2019 |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Human health sciences, Orthopedics, rehabilitation & sports medicine, Sciences de la santé humaine, Orthopédie, rééducation & médecine sportive |
| الوصف: | Objective: The objective was to assess the safety and efficacy of a single intra-articular administration of JTA-004, a novel viscosupplement, in patients suffering from symptomatic knee osteoarthritis (OA) at 6 months.Design and methods: In this prospective, multicenter, double-blind phase II/III trial (NCT02740231), 164 patients with primary OA knee pain were randomly assigned to one of the three JTA-004 strengths or the comparator treatment (Hylan G-F 20) in a 1:1:1:1 ratio. Safety was assessed by monitoring and reporting vital signs, physical examination, adverse events and concomitant medications. The primary efficacy endpoint was the change from baseline at 6 months in WOMAC® VA3.1 pain subscale.Results: JTA-004 was shown to be well tolerated at all strengths evaluated. At 6 months, patients in the three JTA-004 groups showed a better improvement in pain compared to patients in the comparator group although statistical significance was not achieved. As the three JTA-004 strengths had a similar efficacy, a post hoc analysis was subsequently performed between the pooled JTA-004 treated patients and the comparator group. The exploratory analysis showed a 26.1±2.4 (adjusted mean±SE) mm improvement in pain in the pooled JTA-004 group vs. 15.6±4.1 mm in the comparator group at 6 months, demonstrating a statistically significant superiority of JTA-004 over the comparator (p = 0.030).Conclusions: This study provides first evidences of safety and efficacy of JTA-004 in the treatment of symptomatic knee OA. Efficacy will be further confirmed in a subsequent pivotal Phase III study. |
| نوع الوثيقة: | conference paper not in proceedings http://purl.org/coar/resource_type/c_18cp conferencePaper |
| اللغة: | English |
| URL الوصول: | https://orbi.uliege.be/handle/2268/239976 |
| حقوق: | restricted access http://purl.org/coar/access_right/c_16ec info:eu-repo/semantics/restrictedAccess |
| رقم الأكسشن: | edsorb.239976 |
| قاعدة البيانات: | ORBi |
| الوصف غير متاح. |