Impact of a magnetic resonance imaging-guided treat-to-target strategy on disease activity and progression in patients with rheumatoid arthritis (the IMAGINE-RA trial): study protocol for a randomized controlled trial

Table 1 Summary of measures to be collected

Variable
Visit number	0/Screening	1/baseline	2	3	4	5	6	7
Week	−4-0	0	16	32	48	64	80	96
Demographic data
Age – years	A	-	-	-	-	-	-	-
Female sex – no. (%)	A	-	-	-	-	-	-	-
Disease duration	A	-	-	-	-	-	-	-
Duration of RA symptoms	A	-	-	-	-	-	-	-
Smoking status	A	-	-	-	-	-	-	-
Marital status	A	-	-	-	-	-	-	-
Educational and employment status	A	-	-	-	-	-	-	-
*Medical history*
Former and current arthritis treatment	A	-	-	-	-	-	-	-
Concomitant medication	A	A	-	-	A	-	-	A
*Physical examination*
40 joint assessment* (TJC/SJC)	A	A	A	A	A	A	A	A
General physical examination**	A	A	-	-	A	-	-	A
Height – cm	A	A	-	-	A	-	-	A
Weight – kg	A	A	-	-	A	-	-	A
Blood pressure and pulse	A	A	A	A	A	A	A	A
Electrocardiogram	A	-	-	-	-	-	-	-
*Laboratory assessment*
Routine blood tests***	A	A	A	A	A	A	A	A
Anti-CCP and IgM-RF	A	-	-	-	A	-	-	A
Biomarker collection (blood and urine) for bio-bank	-	A	A	A	A	A	A	A
*Patient reported outcomes*
Patient: VAS pain, VAS global, VAS fatigue – range 0-100	A	A	A	A	A	A	A	A
Morning stiffness - min	A	A	A	A	A	A	A	A
HAQ	A	A	A	A	A	A	A	A
SF-36	-	A	-	-	A	-	-	A
EQ-5D	-	A	-	-	A	-	-	A
*Physician’s global assessment of disease activity (VAS) 0-100*	A	A	A	A	A	A	A	A
DAS28 (CRP) score****	A	A	A	A	A	A	A	A
Imaging
X-ray hands and feet	-	A	-	-	A	-	-	A
Controls MRI 2nd to 5th MCP and wrist	-	A	-	-	A	-	-	A
Dynamic MRI*****	-	A	-	-	A	-	-	A
Intervention MRI2nd to 5th MCP and wrist	-	A	A	A	A	A	A	A
Dynamic MRI*****	-	A	A	A	A	A	A	A

A = Assessed; − = not assessed; TJC = tender joint count; SJC = swollen joint count; anti-CCP = anti-citrullinated peptide; IgM-RF = IgM-rheumatoid factor; VAS = visual analog scale; HAQ = health assessment questionnaire; SF-36 = short form (36) health survey; EQ-5D = EuroQol; DAS28 = disease activity score based on assessment of 28 joints; MRI = magnetic resonance imaging; MCP = metacarpophalangeal joints.
*Right and left shoulder joints, elbow joints, wrists, MCP joints, PIP joints, 1st IP joint, knee joints, ankle joints and MTP joints.
**Inspection of the cavum oris, skin, assessment of lymph node status, heart and lung stethoscopy, examination of the abdomen, neurological examination and additional focused examinations if the patient’s medical history suggests presence of other disease.
***Hemoglobin, leucocytes and differential count, CRP, thrombocytes, albumin, creatinine, electrolytes, alkaline phosphatases, alanine amino transaminase. Furthermore, anti-CCP and IgM-RF are also analyzed at baseline and subsequently repeated at months 12 and 24.
****DAS28-4(crp) = 0.56*sqrt (tender joint count 28) + 0.28*sqrt (swollen joint count 28) + 0.36*ln (CRP + 1) + 0.014*GH + 0.96.
*****If technically possible.

ISSN: 1745-6215