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Table 1 Schedule of events in the BIO-FLARE study

From: BIOlogical Factors that Limit sustAined Remission in rhEumatoid arthritis (the BIO-FLARE study): protocol for a non-randomised longitudinal cohort study

Procedures Screening Visit Day 0: Baseline (a)
Telephone consultation
Day 0: Baseline (b)
Synovial biopsy (OPTIONAL)
Day 14 Day 35 Day 56 Day 84 Day 168 Patient-requested ad-hoc study visits Visit 2 weeks following ad-hoc study visit Synovial biopsy assessment visit after flare confirmed
Discuss Study / confirm willingness to continue participation in study X X X X X X X X X X X
Informed Consent for study X           
Collect Demographics and medical history X           
Record Current medication X    X X X X X X X  
General Physical examinationa X           
Rheumatological Assessment - DAS28-CRP X    X X X X X X X  
Instruction to discontinue DMARDs (if not opting for synovial Biopsy)   X          
Instruction to discontinue DMARDs (if opting for synovial biopsy)    X         
Patient Reported Outcome Measures / Questionnaires
 HAQ-DI X        X X X  
 RAPID-3 X    X X X X X X X  
 EuroQol 5D-5L X    X X X X X X X  
 MFI X        X X X  
 RA-FQ X    X X X X X X X  
 FLARE-RA X    X X X X X X X  
Blood tests
 Full Blood Count (FBC) X    X X X X X X X  
 Inflammatory markers (ESR & CRP) X    X X X X X X X  
 Antibodies (RhF & ACPA) X           
 Other clinical bloods (UE, LFT & Clotting) X         X   
 Research blood tests (Serum, EDTA, Tempus and Heparinised samples) X    X X X X X X X  
Other research tests
 Urine Sample X    X X X X X X X  
 Pregnancy testb X           
 Stool Sample (OPTIONAL) X    X X X X X X X  
 Ultrasound assessment for Synovial Biopsy (OPTIONAL AT BASELINE – additional consent required)    [X]         X
 Accelerometer providedc (OPTIONAL) X           
 Activity diary provided (OPTIONAL) X    X X X X   X   
  1. aDepending on the circumstances of the consultation, physical examination may be indicated at any study visit to establish whether DAS28-CRP reflects arthritis activity or infection etc. General Physical Examination is only mandatory at Screening
  2. bMandatory at Screening but should be performed at any visit subsequently if routine questioning suggests a participant may be pregnant. Serum or urine tests to be performed subsequently in line with local policy
  3. cThis may be provided after the study visit once eligibility confirmed, either by post, or at the optional Baseline Synovial Biopsy Visit (if applicable)