Table 1

Summary of measures to be collected

ProtocolBaselineMonth 3Month 6Month 9Every 3 monthsEarly termination or drop-out
Fill out by clinicians
 Inclusion or exclusion standard table
 Sign informed notice
 Patients’ case history and demographic data
 Intercurrent diseases
 Adverse events
 Pregnancy report
 Clinical routine inspection
Filled out by subjects
 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.