A Post Marketing Surveillance Study of INVOSSA K Inj.

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03412864
• Other study ID #: KS-INVOSSA-PMS
• Status: Active, not recruiting
• Start date: July 12, 2017
• Est. completion date: July 11, 2023

Study information

• Verified date: May 2019
• Source: Kolon Life Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: July 11, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Hospital	Daegu	Gyeongsangbuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Kolon Life Science

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs (Adverse Events)	Changes of incidence rate in AEs	0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Secondary	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)
Secondary	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)
Secondary	Physical examination (Tenderness)	Changes of tenderness at each visit	0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Secondary	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)
Secondary	General efficacy evaluation	General efficacy evaluation was assessed by following 4 criteria. (Improved, Not changed, Worsened, Unassessable)	6 Months(visit 3)