Effects of intra-articular administration of Hymovis on the expression and activity of matrix metalloproteinases in synovial fluids of patients affected by osteoarthritis of the knee

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Musculoskeletal Diseases; Osteoarthritis

• Registration Number: ISRCTN81261986
• Lead Sponsor: Fidia Pharmaceuticals S.p.a (Fidia Farmaceutici S.p.a) (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-15
• Study Completion: 2015-09-03
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Synovial fluid analysis will be carried out at baseline and at visit 1<br> 2. MMP3 activity will be evaluated via ELISA test<br>

Secondary Outcome Measures

Name	Time	Method
<br> The following variables will be evaluated at baseline and visit 1:<br> 1. Macroscopic analysis of SF<br> 2. Microscopic analysis of SF<br> 3. Expression of MMP2 and MMP13 (ELISA test)<br> 4. Expression of inflammatory cytokines (Flowcytomix analysis)<br> At baseline and FU visits the following will be considered:<br> 1. VAS<br> 2. WOMAC<br> 3. Physician?s global assessment<br> For all the duration of the study safety and tolerability will be assessed by recording all AE<br>