A Post Marketing Surveillance Study of INVOSSA K Inj.

Post Marketing Surveillance on Safety and Effectiveness Evaluation of INVOSSA K Inj.

This study is post-marketing surveillance of Invossa K injection in patients with osteoarthritis.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of, 42415
      • Yeungnam University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male or female patients over 19 years with osteoarthritis

Description

Inclusion Criteria:

1. Male or female patients over 19 years

2. Patients who diagnosed with osteoarthritis will plan to INVOSSA K Inj. injection and suitable for following criteria :

   - Moderate knee osteoarthritis (Kellgren & Lawrence grade 3) with persistent symptoms (pain, etc.) in spite of conservative therapy (medication, physical therapy, etc.) for more than 3 months

3. Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form

Exclusion Criteria:

1. Pregnant or breastfeeding female
2. Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days
3. Patients who have severe disease such as heart, liver, kidney disease or other severe complications
4. Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis
5. Patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (DMSO), mannitol, dextran 40 or bovine proteins)
6. Patients who have been treated with injections to the target knee within the past three months or patients with a past history of surgery, including arthroscope, within the past six months
7. Patients currently with leukemia or malignant tumors such as osteochondroma, chondroblastoma, cartilaginous mucinous fibrous tumor, chondroma and chondrosarcoma, which may be exacerbated by administration of INVOSSA-K inj. or patients with a history thereof
8. Patients with Kellgran & Lawrence grade 4 osteoarthritis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs (Adverse Events)	Changes of incidence rate in AEs	0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100 mm VAS (Visual Analog Scale)	Changes of 100 mm VAS at each visit (Scale : 0~100, 0 : No pain, 100 : Worst imaginable pain)	0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (Knee joint swelling)	Changes of Knee joint swelling at each visit	0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (Tenderness)	Changes of tenderness at each visit	0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Physical examination (ROM)	Changes of ROM(Range Of Motion) at each visit	0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
General efficacy evaluation	General efficacy evaluation was assessed by following 4 criteria. (Improved, Not changed, Worsened, Unassessable)	6 Months(visit 3)

Collaborators and Investigators

• Sponsor: Kolon Life Science
• Investigators: Principal Investigator: Oog Jin Shon, MD, PhD., Yeungnam University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Anticipated): July 11, 2023
• Study Completion (Anticipated): July 11, 2023

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: osteoarthritis; chondrocyte cells; gene therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: KS-INVOSSA-PMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No