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Table 1 Overview of participant timeline. CRP C-reactive protein, EQ-5D-5L questionnaire assessing quality of life, GDA global disease activity, HAQ health assessment questionnaire, PASS patient acceptable symptom state, RA rheumatoid arthritis, SJC swollen joint count, TJC tender joint count, VAS visual analog scale 0–100 mm

From: Prediction Aided Tapering In rheumatoid arthritis patients treated with biOlogicals (PATIO): protocol for a randomized controlled trial

Visit number

V0 Screening

V1 Baseline

V2

V3

V4

V5

V6

V7

USV

Month

 − 3 to 0

0

3

6

9

12

15

18

Informed consent

X

        

Eligibility criteria

X

        

Demographic data

 

X

       

Medical history

X

        

Anti-rheumatic treatment

X

X

X

X

X

X

X

X

X

Smoking and alcohol use

 

X

       

Height, Weight

 

X

       

Randomization

 

X

       

Clinical disease parameters

 28TJC and 28SJC

X

X

X

X

X

X

X

X

X

 Provider VAS GDA

 

X

X

X

X

X

X

X

X

 Patient VAS GDA

X

X

X

X

X

X

X

X

X

Questionnaires

 HAQ-DI

 

X

X

X

X

X

X

X

 

 EQ-5D-5L

 

X

X

X

X

X

X

X

 

 RA flare questionnairea

 

X

X

X

X

X

X

X

X*

 PASS

 

X

X

X

X

X

X

X

X*

 Likert transition question

 

X

X

X

X

X

X

X

X*

 Health care utilization and work participation

 

X

X

X

X

X

X

X

 

 Patients satisfaction with care (Dutch SAPS)

       

X

 

 Physician satisfaction with care (VAS)

       

X

 

Laboratory assessments

 CRP

 

X

X

X

X

X

X

X

X

Safety/adverse events

 (Serious) Adverse events

 

X

X

X

X

X

X

X

X

  1. USV Unscheduled visit. Patients with complaints of a flare will be encouraged to plan an unscheduled visit
  2. aPatients will also be asked to fill out this questionnaire in between visits at 4-weekly intervals and if patients experience any disease related complaints