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

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ClinicalTrials.gov Identifier: NCT03383471
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Kolon Life Science

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: Invossa K Inj. Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
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
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Invossa K Inj.
Invossa K Inj.
Biological: Invossa K Inj.
Invossa K Inj.

Placebo Comparator: Placebo
Placebo control
Drug: Placebo
Placebo control




Primary Outcome Measures :
  1. IKDC (International knee documentation committee) Subjective Knee Evaluation [ Time Frame: Week 0 and 52 ]
    Changes in IKDC Subjective Knee Evaluation (score)

  2. 100 mm VAS (Visual analogue scale) [ Time Frame: Week 0 and 52 ]
    Changes in 100 mm VAS


Secondary Outcome Measures :
  1. WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score [ Time Frame: Week 0, 26, 39 and 52 ]
    Changes in WOMAC (score)

  2. IKDC Subjective Knee Evaluation [ Time Frame: Week 0, 26 and 39 ]
    Changes in IKDC Subjective Knee Evaluation (score)

  3. 100 mm VAS [ Time Frame: Week 0, 26 and 39 ]
    Changes in 100 mm VAS

  4. OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate [ Time Frame: Week 26, 39 and 52 ]
    OMERACT-OARSI response rate after administration (%)

  5. MRI scan [ Time Frame: Week 0, and 52 ]
    Changes in MRI scan

  6. Joint Space Width [ Time Frame: Week 0, and 52 ]
    Changes in Joint Space Width (mm)

  7. Biomarker (CTX-I) in blood [ Time Frame: Week 0, 26, and 52 ]
    Levels of CTX-I in blood (ng/ml)

  8. Biomarker (CTX-II) in urine [ Time Frame: Week 0, 26, and 52 ]
    Levels of CTX-II in urine (ng/ml)

  9. Rescue Medication (Dosage) [ Time Frame: Week 0, 4, 12, 26, 39, and 52 ]
    Dosage of Rescue Medication (mg)

  10. Rescue Medication (Frequency) [ Time Frame: Week 0, 4, 12, 26, 39, and 52 ]
    Frequency of Rescue Medication (number)

  11. Drop-out rate [ Time Frame: Week 0, 4, 12, 26, 39, and 52 ]
    Drop-out rate (%)

  12. Reason of drop-out [ Time Frame: Week 0, 4, 12, 26, 39, and 52 ]
    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.).



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383471


Locations
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, Korea, Republic of
Sponsors and Collaborators
Kolon Life Science
Investigators
Principal Investigator: Myung-Chul Lee, MD, PhD Department of Orthopedic Surgery, Seoul National University Hospital

Responsible Party: Kolon Life Science
ClinicalTrials.gov Identifier: NCT03383471     History of Changes
Other Study ID Numbers: KS-INV-02-3
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kolon Life Science:
chondrocyte cells
osteoarthritis
gene therapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases