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

Table 1 Schedule of events in the BIO-FLARE 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 examination^a	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 test^b	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 provided^c (OPTIONAL)	X
Activity diary provided (OPTIONAL)	X			X	X	X	X		X

^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
^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
^cThis may be provided after the study visit once eligibility confirmed, either by post, or at the optional Baseline Synovial Biopsy Visit (if applicable)

ISSN: 2520-1026