A post-marketing, pilot study to assess the role of intra-articular administration on the expression and activation of metalloproteinases in synovial fluid.

Fidia Pharmaceuticals S.p.a (Fidia Farmaceutici S.p.a) (Italy)0 个研究点目标入组 30 人开始时间: 2014年9月15日最近更新: 2020年10月26日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Ambulant patient > 45 years of age in good health conditions
•2. Patient of any race, both outpatients or hospitalized, affected by OA diagnosed both clinically and radiologically according to the American College of Rheumatology criteria:
•2.1. Pain
•2.2. Presence of radiographic osteophytes
•2.3. At least one of the following items:
•2.3.1. Age > 50
•2.3.2. Morning stiffness < 30 minutes of duration
•2.3.3. Crepitus on motion
•3. Kellgren-Lawrence grade II-IV confirmed by X-ray (performed within 6 months preceding the inclusion in the study)
•4. Patient diagnosed with idiopathic OA of the knee since at least one year
•5. Patient presenting synovial effusion of the knee joint echographically confirmed
•6. Patient who discontinued previous oral/topic NDAIDs therapy since at least one week before the first intra-articular injection
•7. Male or fertile, non pregnant or breast feeding female who consents to use a reliable birth control method for the whole treatment duration
•8. Patient without conditions or psychological impairment who could interfere with compliance to the protocol and the study conclusion in the investigator's opinion
•9. Patient able to understand study obligations and who provided a written informed consent in compliance with the Helsinki declaration (version October 2013)

排除标准

•1. Concomitant chronic inflammatory diseases (e.g. rheumatoid arthritis or psoriasis)
•2. Painful knee condition other than OA
•3. Secondary knee OA or relevant knee injuries in the target knee within 6 months before the inclusion
•4. Known or suspected allergic reactions to hyaluronic preparations or to other components of the devices under study
•5. Presence of infections and/or skin diseases in the area of injection site; e.g. psoriasis
•6. Known coagulopathy
•7. Therapy with one of the devices under study within 6 months before the inclusion
•8. Systemic anti-inflammatory therapy at a fixed dose within 1 month before the inclusion
•9. In therapy with i.a. HA or i.a. corticosteroids within 6 months before the inclusion
•10. In therapy with biphosphonates, and/or oral pharmaceutical products containing glucosamine and/or chondroitin sulphate and/or diacerein within 1 month before inclusion
•11. Participation in any other study involving investigational or marketed products simultaneously or within one month prior to study entry
•12. Previous surgery in the target knee within 9 months prior to inclusion, or planned surgery throughout the duration of the study
•13. Presence of pathologies or conditions that might interfere with subject compliance/cooperation during the study, in the judgment of the investigator
•14. History of alcoholism, treatment abuse, psychological or other emotional problems that, in the judgment of the investigator, could invalidate informed consent or limit the subjects compliance with protocol requirements
•15. Females who are pregnant, lactating or not in menopause and are not using recognized contraceptive measures as indicated by investigators for the duration of the study

研究者

发起方

Fidia Pharmaceuticals S.p.a (Fidia Farmaceutici S.p.a) (Italy)

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