Table 2 Timing of visits and data collection (SPIRIT)

Informed consent

x

Inclusion/exclusion

x

x

x

x

x

Demographics

x

Medical history

x

Concomitant medication

x

x

x

x

x

Hand pain 0–10 NRS

x

x

x

x

x

Pain manikin

x

x

x

Physical examination

x

x

x

x

Vital signs

x

x

x

x

Blood screening

x

Urine dipstick

x

X^a

X^a

X^a

X^a

Urine pregnancy test

X^a

X^a

X^a

X^a

X^a

Bilateral hand X-ray (if applicable)

x

Hand pain rating (remote)

Training

x

x

x

x

Randomisation

x

Prescription/dispensing

x

x

Reported study medication compliance

x

x

x

Advice on barrier contraception

X^a

X^a

X^a

X^a

Joint count

x

x

x

Questionnaires

x

x

x

Photographs of swollen hand joints

x

x

x

Grip strength

x

x

x

Safety blood monitoring ^c

x

x

x

Safety/adverse events

x

x

x

x

Advice on weaning off study medication

x

Bang’s Blinding Index

x

End of treatment questionnaire

x

Focus group^b (optional)