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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03383471
Recruitment Status : Not yet recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
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
Anticipated Study Start Date : January 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
U.S. FDA Resources

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, Senior)
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


Contacts
Contact: Young-ji Bae, MS 82-02-3677-4198 ext 4198 youngji_bae5@kolon.com
Contact: Jong Hyuk Jung, MS 82-02-3677-4236 ext 4236 jonghyuk_jung@kolon.com

Locations
Korea, Republic of
Korea University Anam Hospital Not yet recruiting
Ansan, Korea, Republic of
Contact: Seung-Beom Han, MD, PhD         
Principal Investigator: Seung-Beom Han, MD, PhD         
Inje University Busan Paik Hospital Not yet recruiting
Busan, Korea, Republic of
Contact: Chang-Wan Kim, MD, PhD         
Principal Investigator: Chang-Wan Kim, MD, PhD         
Kyungpook National University School of Medicine Not yet recruiting
Daegu, Korea, Republic of
Contact: Hee-Soo Kyung, MD, PhD         
Principal Investigator: Hee-Soo Kyung, MD, PhD         
Chungnam National University School of Medicine Not yet recruiting
Daejeon, Korea, Republic of
Contact: Young-Mo Kim, MD, PhD         
Principal Investigator: Young-Mo Kim, MD, PhD         
Chonnam National University Hwasun Hospital Not yet recruiting
Hwasun, Korea, Republic of
Contact: Jong-Keun Seon, MD, PhD         
Principal Investigator: Jong-Keun Seon, MD, PhD         
Inha University Hospital Not yet recruiting
Incheon, Korea, Republic of
Contact: Myung-Gu Kim, MD, PhD         
Principal Investigator: Myung-Gu Kim, MD, PhD         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Seong-Il Bin, MD, PhD         
Principal Investigator: Seong-Il Bin, MD, PhD         
College of Medicine, Hanyang University Not yet recruiting
Seoul, Korea, Republic of
Contact: Choong-Hyeok Choi, MD, PhD         
Principal Investigator: Choong-Hyeok Choi, MD, PhD         
Ewha Womans University Mokdong Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jae-Doo Yoo, MD, PhD         
Principal Investigator: Jae-Doo Yoo, MD, PhD         
Konkuk University Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jin Goo Kim, MD, PhD         
Principal Investigator: Jin Goo Kim, MD, PhD         
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Chul-Won Ha, MD, PhD         
Principal Investigator: Chul-Won Ha, MD, PhD         
School of Medicine, Kyung Hee University Not yet recruiting
Seoul, Korea, Republic of
Contact: Kyoung-Ho Yoon, MD, PhD         
Principal Investigator: Kyoung-Ho Yoon, MD, PhD         
Seoul National University Borame Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Chong Bum Chang, MD, PhD         
Principal Investigator: Chong Bum Chang, MD, PhD         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Myung-Chul Lee, MD, PhD         
Principal Investigator: Myung-Chul Lee, MD, PhD         
The Catholic University of Korea College of Medicine Not yet recruiting
Seoul, Korea, Republic of
Contact: Yong In, MD, PhD         
Principal Investigator: Yong In, MD, PhD         
Yonsei University School of Medicine Not yet recruiting
Seoul, Korea, Republic of
Contact: Chong Hyuk Choi, MD, PhD         
Principal Investigator: Chong Hyuk Choi, MD, PhD         
Ajou University School of Medicine Not yet recruiting
Suwon, Korea, Republic of
Contact: Ye-Yeon Won, MD, PhD         
Principal Investigator: Ye-Yeon Won, MD, PhD         
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: December 26, 2017
Last Verified: December 2017

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