Assessment of Protective Effect of JOINS on Cartilage in Knee Osteoarthritis

Phase 4

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Placebo; Drug: JOINS 200mg

• Registration Number: NCT01293955
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-11
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
JOINS 200mg	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.

Primary Outcome Measures

Name	Time	Method
Knee MRI	up to 4 times

Secondary Outcome Measures

Name	Time	Method
K-WOMAC	up to 6 times
Knee pain(VAS)	up to 6 times
Consumption of rescue medication	up to 6 times	The quantity of rescue medicine will be counted by investigator and recorded in official clinical research document form.
Knee radiography	up to 4 times
Biomarker	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.

Trial Locations

Locations (1)

Seoul National University hospital; 🇰🇷 Seoul, Korea, Republic of