NCT03412864

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

6 years

First QC Date

January 19, 2018

Last Update Submit

May 24, 2019

Conditions

Osteoarthritis

Keywords

chondrocyte cellsosteoarthritisgene therapy

Outcome Measures

Primary Outcomes (1)

  • AEs (Adverse Events)

    Changes of incidence rate in AEs

    0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)

Secondary Outcomes (5)

  • 100 mm VAS (Visual Analog Scale)

    0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)

  • Physical examination (Knee joint swelling)

    0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)

  • Physical examination (Tenderness)

    0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)

  • Physical examination (ROM)

    0 month(visit 1), 1 month(visit 2) and 6 Months(visit 3)

  • General efficacy evaluation

    6 Months(visit 3)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male or female patients over 19 years with osteoarthritis

You may qualify if:

  • Male or female patients over 19 years
  • 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
  • Patients (or substitute) who is provided all information regarding participation of this PMS signed the informed consent form

You may not qualify if:

  • Pregnant or breastfeeding female
  • Patients who have administered corticosteroid before INVOSSA K Inj. injection within the past 30 days
  • Patients who have severe disease such as heart, liver, kidney disease or other severe complications
  • Patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis
  • 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)
  • 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
  • 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
  • Patients with Kellgran \& Lawrence grade 4 osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeungnam University Hospital

Daegu, Gyeongsangbuk-do, 42415, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Oog Jin Shon, MD, PhD.

    Yeungnam University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 29, 2018

Study Start

July 12, 2017

Primary Completion

July 11, 2023

Study Completion

July 11, 2023

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

KR(1)