METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritis with Synovitis: study protocol for a randomised controlled trial

Table 1 Timetable and measures to be made

	Screening		Double blind period
	Screening / baseline assessment	Post-screening	MRI & randomisation	Week 2	Week 4	Week 8	Months 3	Months 6
Visit/phone contact	0	1	2	3	4	5	6	7
Informed consent¹	X
Blood tests²		X
Safety blood tests³				X	X	X	X	X
Telephone follow-up				X		X
Clinical visit	X				X		X	X
Hand x-ray		X^a						X^a
Chest x-ray⁴		X
Hand MRI			X					X
Medical history including vaccination	X						X	X
Medications and allergies¹	X				X		X	X
Employment and education	X
Smoking	X
Alcohol consumption	X			X	X	X	X	X
Marital status and parity	X
Questionnaires
Hand VAS	X				X		X	X
AUSCAN, FIHOA, HAQ, MHQ	X						X	X
SF-36	X							X
Knee WOMAC, painDETECT	X							X
Physical examination
Height, weight, waist and hip circumference	X
Grip strength	X						X	X
Tender/swollen joint count¹	X				X		X	X
Cardiovascular (including blood pressure), respiratory, abdominal, skin examination	X
Compliance and safety (AEs)¹				X	X	X	X	X
Dispense medication			X				X
Pill count					X		X	X

MRI magnetic resonance imaging, VAS Visual Analogue Scale, AUSCAN Australian Canadian Osteoarthritis Hand Index, FIHOA Functional Index for Hand Osteoarthritis, HAQ Health Assessment Questionnaire, MHQ Michigan Hand Outcomes Questionnaire, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, AE adverse event
^aBaseline and follow-up x-ray performed at the same centre using a standardized protocol
¹To be performed/reviewed by study doctor
²Full blood count, kidney function test, liver function test, C-reactive protein, erythrocyte sedimentation rate, rheumatoid factor, anti-cyclic citrullinated peptide antibodies, human immunodeficiency virus, Hepatitis B (sAb, sAg and cAb), Hepatitis C, and Quantiferon Gold
³Full blood count, kidney function test, and liver function test
⁴Not required if chest x-ray in last 12 months is available

ISSN: 1471-2474