Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis (Joins_Carp_Ⅳ)

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. Read our disclaimer for details. Identifier: NCT01293955
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : April 24, 2015
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.

Brief Summary:
  • A Pilot study
  • Randomized and Double-blinded
  • Placebo controlled
  • In 2 parallel group (JOINS 200mg:Placebo = 1:1)
  • Overall 24 months treatment (JOINS:Placebo comparison up to 12 months, Additional follow-up assessment up to 24 months)
  • Provide rescue medicine throughout whole clinical trial period.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: JOINS 200mg Drug: Placebo Phase 4

Detailed Description:
  1. Assessment of Efficacy

    1. Knee MRI(Magnetic resonance imaging):

      • Assessment of cartilage volume, thickness in target knee
      • GAG(glycosaminoglycan) concentration of target knee
      • Assessment of Whole-Organ Magnetic Resonance Imaging Score (WORMS) of target knee
    2. Knee radiography:

      • Assessment of changes in minimal medial JSW(Joint Space Width) of target knee.
    3. Knee pain(VAS)

      • Assessment changes of pain in target knee.
    4. K-WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index for Korean)

      • Assessment score change for pain(5 questions), stiffness(2 questions) and physical function(17 questions).
      • The questionnaire is self-administered by the patients.
    5. Used frequency of rescue medicine.
    6. Biochemical cartilage and bone markers

      • Blood and urine sample will be collected all through the morning after a night fasting period since 10 pm the previous day to avoid the variations.
  2. Assessment of Safety

    1. Adverse event
    2. Laboratory assessment
    3. Vital sign
    4. 12-lead ECG
    5. Physical examination
  3. Enrollment: 76

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blinded, Parallel Group, Placebo-controlled Clinical Trial to Assess the Protective Effect of JOINS on Cartilage in Knee Osteoarthritis
Study Start Date : August 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: JOINS 200mg
One tablet of JOINS 200mg is administered three times a day for 1 year. The subjects who consent to participate in an extension study are treated with JOINS 200mg for another 1 year.
Drug: JOINS 200mg
1 tablet at each time, 3 times a day
Other Name: JOINS

Placebo Comparator: Placebo
One tablet of Placebo is administered three times a day for 1 year. The subjects who consent to participate in an extension study are treated with Placebo for another 1 year.
Drug: Placebo
placebo of Joins 200mg

Primary Outcome Measures :
  1. Knee MRI [ Time Frame: up to 4 times ]

Secondary Outcome Measures :
  1. Knee radiography [ Time Frame: up to 4 times ]
  2. Knee pain(VAS) [ Time Frame: up to 6 times ]
  3. K-WOMAC [ Time Frame: up to 6 times ]
  4. Consumption of rescue medication [ Time Frame: up to 6 times ]
    The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.

  5. Biomarker [ Time Frame: up to 6 times ]
    Patients will need to be strictly fasting from the night before the visit. The data of biological cartilage and bone markers will be collected.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. A female is eligible if she is of:

    • Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
    • Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
    • Pregnancy test result of negative at screening
  2. Primary Knee OA(Osteoarthritis) on medial femorotibial compartment based on ACR(American College Rheumatology) Criteria.

    • ACR Criteria : With Knee pain and satisfied at least 1 of 3 (① age > 50 years, morning stiffness < 30 minute, ③ Presence of Crepitus and Osteophytes on motion)
  3. Appropriately signed and dated informed consent has been obtained

Exclusion Criteria:

  1. Rheumatoid arthritis or inflammatory arthritis.
  2. Bilateral total knee replacement already treated, or planning for the procedure.
  3. Knee prosthesis already implanted, or foreseen within the next year.
  4. Clinically significant hip osteoarthritis.
  5. Severe renal insufficiency defined as creatinine clearance < 30ml/mln(Cockcroft formula).
  6. Clinically significant pulmonary, hepatic, renal or heart disorder or diagnosis crucial disease by investigator ( Glycosuria(Diabetes mellitus) or asthma patients are excluded from this clinical study and the patients who has a clinically significant disease are also excluded.).
  7. MRI contraindications : overweight, inferior limb diameter non-fitting the knee antenna, inserted pace-maker, metallic prosthesis( if known to interfere with MRI procedure or if known to be unsafe for MRI), metallic clips, insulin pump, cytostatic pump, hearing aid, essential tremor, claustrophobia, etc,.
  8. Allergic reaction to Clinical trial medication.
  9. Other clinical trial drugs during the 1 month prior to the screening visit.

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 identifier (NCT number): NCT01293955

Korea, Republic of
Seoul National University hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Principal Investigator: Myoungchul Lee, PH.D.. Orthopedics, Seoul National University hospital

Responsible Party: SK Chemicals Co.,Ltd. Identifier: NCT01293955     History of Changes
Other Study ID Numbers: Joins_Carp_IV_2009
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by SK Chemicals Co.,Ltd.:
knee osteoarthritis
protective effect

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