The Efficacy and Safety of Invossa K Injection in Patients Diagnosed With Knee Osteoarthritis

NCT03383471 | Unknown Phase 3

• 1 other identifier: KS-INV-02-3
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K Injection patients diagnosed with Kellgren \& Lawrence grade 2 knee osteoarthritis.

Conditions

Osteoarthritis

Keywords

chondrocyte cells; osteoarthritis; gene therapy

Outcome Measures

Primary Outcomes (2)

• IKDC (International knee documentation committee) Subjective Knee Evaluation

  Changes in IKDC Subjective Knee Evaluation (score)

  Week 0 and 52

• 100 mm VAS (Visual analogue scale)

  Changes in 100 mm VAS

  Week 0 and 52

Secondary Outcomes (12)

• WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score

  Week 0, 26, 39 and 52

• IKDC Subjective Knee Evaluation

  Week 0, 26 and 39

• 100 mm VAS

  Week 0, 26 and 39

• OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate

  Week 26, 39 and 52

• MRI scan

  Week 0, and 52

Study Arms (2)

Invossa K Inj.

EXPERIMENTAL

Invossa K Inj.

Biological: Invossa K Inj.

Placebo

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Interventions

Invossa K Inj. BIOLOGICAL

Invossa K Inj.

Invossa K Inj.

Placebo DRUG

Placebo control

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 19 and older
• Patients with IKDC Subjective Knee Evaluation of ≤ 60 of the target knee.
• Patients with a score of ≥ 40 on the 100 mm pain VAS of the target knee.
• Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
• BMI should fall between 18.5 and 30
• Patients who satisfies the clinical/radiational criteria by the American College of Rheumatology guidelines, and applies to one of the following.
• Age \> 50 years old
• Morning stiffness \< 30 minutes
• Crepitus and Osteophytes
• With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
• Patients with persistent symptoms in spite of conservative therapy for more than 3 months : Improvement of 100 mm VAS are less than 10 mm after 3 months
• Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
• Agreed to use an effective contraceptive method during the study period
• Voluntarily agreed to participate in this study, and signed the informed consent form

You may not qualify if:

• Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
• Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)
• Patients with severe pain in other areas that could effect the diagnosis of the symptoms
• Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
• History of surgery like arthroendoscopy within the past 6 months on the target knee
• Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months
• History of injection within the past 3 months on the target knee
• Pregnant or breastfeeding female
• With another joint disease apart from degenerative arthritis
• Patients with hepatitis including carrier
• Patients with HIV and an infectious disease which is clinically uncontrolled
• Patients who have any of the following clinically significant diseases or have a medical history within 6 months :
• Clinically significant heart diseases which are considered by the investigator
• Uncontrolled hypertension : if the systolic blood pressure exceeds 160 mmHg or diastolic blood pressure exceeds 100 mmHg in a sitting position
• Kidney disease

Sponsors & Collaborators

• Kolon Life Science: lead

Study Sites (17)

Korea University Anam Hospital

Ansan, South Korea

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Kyungpook National University School of Medicine

Daegu, South Korea

Location

Chungnam National University School of Medicine

Daejeon, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

College of Medicine, Hanyang University

Seoul, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

School of Medicine, Kyung Hee University

Seoul, South Korea

Location

Seoul National University Borame Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

The Catholic University of Korea College of Medicine

Seoul, South Korea

Location

Yonsei University School of Medicine

Seoul, South Korea

Location

Ajou University School of Medicine

Suwon, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Myung-Chul Lee, MD, PhD

  Department of Orthopedic Surgery, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 26, 2017
• Study Start: February 12, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 30, 2020
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

KR (17)