Study protocol for a randomised controlled trial of diacerein versus placebo to treat knee osteoarthritis with effusion-synovitis (DICKENS)

Table 1 Schedule of assessments

	Screening		Double-blind period
	Screening Clinic visit or Telehealth	Post-screening	Baseline (week 0) Clinic visit or Telehealth	Week 2	Week 4	Week 8	Week 12 Clinic visit or Telehealth	Week 16	Week 20	Week 24 Clinic visit or Telehealth
Informed consent^a	x
Knee x-ray^b		x
Bloods (safety and storage)^c		x					x			x
Urine^d	x
Knee MRI		x^e								x
Randomisation			x
Clinic visit or Telehealth	x		x				x			x
ACR clinically diagnosed OA	x
Leg strength			x^f				x^f			x^f
Height and weight			x^g				x^g			x^g
Capsules dispensed			x^h				x^h
Dosage increase				x
Capsule count (adherence)							xⁱ			x^j
Questionnaire measures	x		x		x	x	x	x	x	x
Demographics (sex, DOB)	x
Medicare number			x
Knee VAS	x		x		x	x	x	x	x	x
WOMAC pain/function/stiffness			x		x	x	x	x	x	x
OMERACT-OARSI Responder criteria			x		x	x	x	x	x	x
Knee surgery and injections	x		x		x	x	x	x	x	x
Medication use	x		x				x			x
Safety (adverse events)				x	x	x	x	x	x	x
AQoL-8D and EQ-5D-5L			x				x			x
Health economics outcomes: Medication cost diary Health service utilisation Employment/days off work Concession/Health Care Card Private health insurance Transport and specialised equipment costs			x							x
painDETECT			x				x			x
Depression			x				x			x
Fibromyalgia-ness			x				x			x
Treatment guessing							x			x
Consent to be contacted for future studies										x
Early withdrawal information				As required

^aTo be performed/reviewed by the study doctor
^bTo exclude severe knee OA (defined by bone on bone present on x-ray using the OARSI atlas [34]) or to ensure radiographic knee OA is present for Telehealth Screening Appointments only. Old films will be accepted up to 2 years ago
^cBlood tests will be performed at screening, weeks 12 and 24 to exclude participants with abnormal liver and kidney function. Blood samples will also be stored for future biomarker testing
^dPerformed only in premenopausal women where there is a possibility of pregnancy
^eKnee MRI performed to determine the presence of effusion-synovitis. MRI is only performed once the participant meets all other inclusion/exclusion criteria (i.e. x-ray and blood test results meet inclusion/exclusion criteria)
^fWill not be assessed/recorded during Telehealth appointments
^gWill be self-reported if possible, during Telehealth appointments
^hParticipants must complete the safety pathology testing at screening to be enrolled in the study and dispensed study medication. Safety pathology testing is also required at week 12 before the study medication is dispensed
ⁱDuring Telehealth appointments, participants will be provided with a reply-paid envelope to return their unused study medication for capsule counting

ISSN: 1745-6215