| Screening visit | Allocation | Post allocation | |||
---|---|---|---|---|---|---|
Time point | Up to 4Â weeks before BL | 0 | Baseline visit (BL) | Week 1 | Week 4 | Week 16 (end) |
Enrolment: | Â | Â | Â | Â | Â | Â |
 Eligibility screening | x |  |  |  |  |  |
 Informed consent | x |  |  |  |  |  |
 Screening knee X-ray | x |  |  |  |  |  |
 Screening blood test * | x |  |  |  |  |  |
 Physical Examination | x |  | x | x | x | x |
Interventions: | Â | Â | Â | Â | Â | Â |
 Colchicine 0.5 mg bid |  |  | Start here |  |  | End here |
 Placebo 1 tablet bid |  |  | Start here |  |  | End here |
Assessments: | Â | Â | Â | Â | Â | Â |
 Physical Examination | x |  | x | x | x | x |
 Full blood count | x |  |  |  |  | x |
 Renal function test | x |  |  | x | x | x |
 Liver function test | x |  |  | x | x | x |
 Uric acid | x |  |  | x | x | x |
 CPK | x |  |  | x | x | x |
 βHCG (for women with child bearing potential) | x |  |  |  |  |  |
 Blood biomarkers collection |  |  | x | x | x | x |
 Urine biomarkers collection |  |  | x | x | x | x |
 Blood for pharmcogenomic |  |  | x |  |  |  |
 Colchicine level |  |  | x | x | x | x |
 Both knees aspiration |  |  | x |  |  | x |
 Knee X-ray (both sides) | x |  |  |  |  |  |
 MRI of signal knee ǂ (for 20 subjects only) |  | x |  |  |  |  |
 Adverse event enquiries |  |  | x | x | x | x |
 Enquiries to compliance to usual medications for knee |  |  | x | x | x | x |
 Clinical data collection |  |  | x |  |  | x |
 Pain score enquiries (signal knee) |  |  | x | x | x | x |
 Demographic data collection |  |  | x |  |  |  |
 WOMAC |  |  | x |  |  | x |
 HAQ |  |  | x |  |  | x |
 SF36v2 |  |  | x |  |  | x |