A Post Marketing Surveillance Study of INVOSSA K Inj.

Kolon Life Science

Status: Unknown

Conditions: Osteoarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT03412864

KS-INVOSSA-PMS

Details and patient eligibility

About

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

Enrollment: 3,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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