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

Osteoarthritis Clinical Trial

Official title:

A Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Invossa K Injection in Patients Diagnosed as Knee Osteoarthritis With Kellgren & Lawrence Grade 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03383471
• Other study ID #: KS-INV-02-3
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 11, 2017
• Last updated: March 5, 2018
• Start date: February 12, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: March 2018
• Source: Kolon Life Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 146
• Est. completion date: March 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Male or female aged 19 and older

2. Patients with IKDC Subjective Knee Evaluation of = 60 of the target knee.

3. Patients with a score of = 40 on the 100 mm pain VAS of the target knee.

4. Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence

5. BMI should fall between 18.5 and 30

6. 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

7. With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms

8. 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

9. Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history

10. Agreed to use an effective contraceptive method during the study period

11. Voluntarily agreed to participate in this study, and signed the informed consent form

Exclusion Criteria:

1. 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)

2. Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period)

3. Patients with severe pain in other areas that could effect the diagnosis of the symptoms

4. Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence

5. History of surgery like arthroendoscopy within the past 6 months on the target knee

6. Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months

7. History of injection within the past 3 months on the target knee

8. Pregnant or breastfeeding female

9. With another joint disease apart from degenerative arthritis

10. Patients with hepatitis including carrier

11. Patients with HIV and an infectious disease which is clinically uncontrolled

12. 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

• Liver disease

• Endocrine disease

• Uncontrolled diabetes mellitus : HbA1c = 9%

• Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease

• Genetic diseases (hyperkinesia, collagen gene abnormality)

13. Medical history of past or current malignant tumor

14. Patients with a history of anaphylactic reactions

15. Patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide, mannitol, dextran 40 or bovine proteins

16. Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study

17. Patients who administered the INVOSSA K inj.

18. Considered inappropriate by the investigator for participation in this study

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Invossa K Inj.
Invossa K Inj.

Drug:
• Placebo
Placebo control

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Ansan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Kyungpook National University School of Medicine	Daegu
Korea, Republic of	Chungnam National University School of Medicine	Daejeon
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	College of Medicine, Hanyang University	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	School of Medicine, Kyung Hee University	Seoul
Korea, Republic of	Seoul National University Borame Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea College of Medicine	Seoul
Korea, Republic of	Yonsei University School of Medicine	Seoul
Korea, Republic of	Ajou University School of Medicine	Suwon

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	IKDC (International knee documentation committee) Subjective Knee Evaluation	Changes in IKDC Subjective Knee Evaluation (score)	Week 0 and 52
Primary	100 mm VAS (Visual analogue scale)	Changes in 100 mm VAS	Week 0 and 52
Secondary	WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score	Changes in WOMAC (score)	Week 0, 26, 39 and 52
Secondary	IKDC Subjective Knee Evaluation	Changes in IKDC Subjective Knee Evaluation (score)	Week 0, 26 and 39
Secondary	100 mm VAS	Changes in 100 mm VAS	Week 0, 26 and 39
Secondary	OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate	OMERACT-OARSI response rate after administration (%)	Week 26, 39 and 52
Secondary	MRI scan	Changes in MRI scan	Week 0, and 52
Secondary	Joint Space Width	Changes in Joint Space Width (mm)	Week 0, and 52
Secondary	Biomarker (CTX-I) in blood	Levels of CTX-I in blood (ng/ml)	Week 0, 26, and 52
Secondary	Biomarker (CTX-II) in urine	Levels of CTX-II in urine (ng/ml)	Week 0, 26, and 52
Secondary	Rescue Medication (Dosage)	Dosage of Rescue Medication (mg)	Week 0, 4, 12, 26, 39, and 52
Secondary	Rescue Medication (Frequency)	Frequency of Rescue Medication (number)	Week 0, 4, 12, 26, 39, and 52
Secondary	Drop-out rate	Drop-out rate (%)	Week 0, 4, 12, 26, 39, and 52
Secondary	Reason of drop-out	Reason of drop-out is recorded in CRF (Case Report Form), when the patient is dropped-out according to drop-out criteria (e.g. Withdraw a consent, Patients who can not continuously participate in study due to adverse events, Impossible to follow-up of the patient. etc.).	Week 0, 4, 12, 26, 39, and 52