Table 1

Summary of measures to be collected

Protocol	Baseline	Month 3	Month 6	Month 9	Every 3 months	Early termination or drop-out
Fill out by clinicians
Inclusion or exclusion standard table	√
Sign informed notice	√
Patients’ case history and demographic data	√
Intercurrent diseases	√
DAS28-ESR or DAS28-CRP	√	√	√	√	√	√
Adverse events		√	√	√	√	√
Pregnancy report	√	√	√	√	√	√
Clinical routine inspection	√	√	√	√	√	√
Filled out by subjects
HAQ-DI	√	√	√	√	√	√
SF-36	√	√	√	√	√	√
EQ-5D	√	√	√	√	√	√
WPAI	√	√	√	√	√	√
HCRU	√	√	√	√	√	√
PGIC		√	√	√	√	√
SAS	√	√	√	√	√	√
SDS	√	√	√	√	√	√
Satisfaction questionnaires post-treatment	√	√	√	√	√	√

CRP, C reactive protein; DAS28, Disease Activity Score on 28 joints; EQ-5D, European Quality of Life-5 Dimensions; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; HCRU, healthcare resource utilisation; PGIC, Patient Global Impression Change; SAS, Self-Rating Anxiety Scale; SDS, Self-Rating Depression Scale; SF-36, Short Form 36 Health Survey Questionnaire; WPAI, Work Productivity and Activity Impairment Questionnaire.