Table 2 Primary and secondary outcomes
Outcome | Time points |
|---|---|
Primary outcomes | |
 Knee pain: VAS score | 24 weeks |
 Knee effusion-synovitis: maximal area, volume, ordinal measures (MRI) | 24 weeks |
Secondary outcomes | |
 BML: maximal area | 24 weeks |
 Effusion volume (ultrasound)γ | 24 weeks |
 Knee pain: VAS score | 4, 8, 12, 16, 20 weeks |
 Knee pain: total WOMAC pain, weight bearing and non-weight bearing pain | all time points |
 Hand and back pain (VAS) | All time points |
 Knee function | All time points |
 OMERACT–OARSI responder criteria [41] | All time points |
 hs-CRP | 12 and 24 weeks |
 Blood lipids | 12 and 24 weeks |
 Blood glucose | 12 and 24 weeks |
 Leg strength | 12 and 24 weeks |
 Analgesic use | All time points |
 Quality of life (AQoL-6D) | 12 and 24 weeks |
 Pressure pain threshold testing on study knee¥ | 24 weeks |
 Adverse events | 12 and 24 weeks |
 Medication persistence | 12 and 24 weeks |
Cost data: hospitalisation, medication use, joint replacement | Â |