Table 1 Trial Flowchart and Schedule of Visits

Registration Form

X

Demographics

X

Eligibility checks ^b

X

Medical History

X

Physical Examination

X

X

X

X

X

Disease Activity Assessments

X

X

X

X

X

X

X

X

X

X-rays of hands & feet ^c

X^c

Ultrasonography of symptomatic joints and limited joint set ^d

X^d

X^d

X^d

X^d

X^d

ACR/EULAR remission

X

X

X

X

X

X

X

X

X

IMP supply for weekly SC dosing ^e

X

X

X

X

Treatment Log (IMP)

X

X

X

X

ESR & CRP ^f

X

X

X

X

X

X

X

X

X

Routine Bloods (Haem & Biochem) ^{g n}

X^g

X

X

X

X

Xⁿ

Xⁿ

Xⁿ

Xⁿ

Screening Bloods (HIV, Hep B& C, TB) ^c

X^c

Chest X-ray ^c

X^c

Lifestyle Factors Questionnaire

X

X

X

X

X

Symptoms in Persons At Risk of Rheumatoid Arthritis (SPARRA) questionnaire ^h

X^h

X^h

Health Assessment Questionnaire (HAQ)

X

X

X

X

X

X

X

X

X

Modified Illness Perception Questionnaire (IPQ-R)

X

X

X

X

X

Euro-Quality of Life Questionnaire (EQ-5D)

X

X

X

X

X

Hospital Anxiety and Depression Scale (HADs)

X

X

X

X

Functional Assessment Of Chronic Illness Therapy-Fatigue Questionnaire (FACIT-F)

X

X

X

X

X

RA Work Instability Scale (RA-WIS)

X

X

X

X

X

Perceptions of Trial Participation Questionnaire ⁱ

Xⁱ

Concomitant Medication

X

X

X

X

X

X

X

X

X

Adverse Events

X

X

X

X

X

X

X

X

X

Compliance checks ^j

X

X

X

X

Status Form

X

X

X

X

X

X

X

X

Withdrawal Form ^k

X^k

X^k

X^k

X^k

X^k

X^k

X^k

X^k

Blood/Urine for biomarkers ^l

X

X

X

X

X

X

X

X

X