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

SK chemicals

Status and phase: Completed; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Placebo; Drug: JOINS 200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01293955

Joins_Carp_IV_2009

Details and patient eligibility

About

• 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.

Full 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

Enrollment: 76 patients

Sex: All

Ages: 45 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

JOINS 200mg

Experimental group

Description:

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.

Treatment:

Drug: JOINS 200mg

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo