Clinical trial NCT03412864: A Post Marketing Surveillance Study of INVOSSA K Inj.
Official title: Post Marketing Surveillance on Safety and Effectiveness Evaluation of INVOSSA K Inj.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: chondrocyte cells
osteoarthritis
gene therapy
Lead sponsor: Kolon Life Science
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female patients over 19 years with osteoarthritis

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


Eligibility criteria: 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

Primary outcomes:
measure: AEs (Adverse Events)
timeFrame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
Secondary outcomes:
measure: 100 mm VAS (Visual Analog Scale)
timeFrame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
measure: Physical examination (Knee joint swelling)
timeFrame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
measure: Physical examination (Tenderness)
timeFrame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
measure: Physical examination (ROM)
timeFrame: 0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)
measure: General efficacy evaluation
timeFrame: 6 Months(visit 3)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Gyeongsangbuk-do
Study officials:
affiliation: Yeungnam University Hospital
name: Oog Jin Shon, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: