Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HYALEXO

NCT05229458 | Unknown

• 1 other identifier: YYDATP-PMCF
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial is a post marketing clinical follow up study, aiming to evaluate the performance and safety of Hyalexo for pain relief in patients suffering from osteoarthritis or degenerative joint diseases. The study will involve 54 subjects, who will be enrolled in 4 centers in France. The performance outcomes will be evaluated by the koos score, and VAS for pain, while the safety outcomes will be assessed by a safety checklist and by collecting all the adverse events (Adverse Event/Adverse Device Effect/Serious Adverse Event/Serious Adverse Device Effect/Unanticipated Serious Adverse Device Effect/Device Deficiencies) at all visits.

Conditions

Osteoarthritis; Degenerative Joint Disease

Outcome Measures

Primary Outcomes (1)

• KOOS for Pain at 12 weeks

  • Functional assessment of HYALEXO® by KOOS (Knee Injury and Osteoarthritis Outcome score) for Pain subscale at 12 weeks after the last administration of the investigational product, compared to the baseline. This was the endpoint used for the sample size calculation.

  12 weeks

Secondary Outcomes (6)

• KOOS for Symptoms, Activity of Daily Living, Sport and Recreation and knee related Quality of life

  1,6,12 weeks and 6 months

• KOOS for Pain at 1, 6 weeks and 6 months

  1, 6 weeks and 6 months

• Weight-bearing pain using a Visual Analogue Scale(VAS)

  1,6,12 weeks and 6 months

• Changes is rest pain(VAS)

  1,6,12 weeks and 6 months

• Changes in motion pain(VAS)

  1,6,12 weeks and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Four centres in France (about 13 - 14 patients enrolled each; the enrolment is competitive).

You may qualify if:

• Patients older than 18 years old(inlcusive≥18years).
• Men or women.
• Patients suffering from painful chronic idiopathic symptomatic degenerative joint diseases(clinical evidence) OR knee osteoarthritis (as defined by the American College of Rheumatology (ACR) criteria); for patients with osteoarthritis at both knees, only the most painful one will be included in the study.
• VAS knee pain≥40mm at screening and 30 days before.
• Patients willing and able to comply with study terms.
• Patients willing to discontinue all other degenerative joint diseases or knee osteoarthritis treatments.

You may not qualify if:

• Patients that are unable or unwilling to provide informed consent and/or patients participating in a concurrent clinical trial and/or patients that have participated in a similar clinical trial within the last 30 days.
• Patients with known hypersensitivity to any components of investigational product.
• Patients with infected or severely inflamed joints
• Patients with skin diseases or infections in the area of the injection site.
• Patients with hepatic failure or history thereof.
• Protected persons defined in the following articles of the French Public Health Code:
• L. 1121-5 pregnant women or breastfeeding.
• L. 1121-6: persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than that of research.
• L. 1121-7: minors.
• L. 1121-8: adults who are subject to legal protection measures or out of state to express their consent.
• L. 1122-1-2: people in emergency situations who cannot give prior consent.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jerome Porterie, Dr

  Cabinet de Cabinet de Rhumatologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Barattini, MD

CONTACT

+40 774012684; franco.barattini@tigermedgrp.com

Rawia Harb, JuniorCRA

CONTACT

+39 3338316738; rawia.harb@tigermedgrp.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 8, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04