Table 2.

Vaccine Response On/Off Methotrexate study research assessments at different time points

Assessments	Prebooster (baseline)*	Booster vaccine date known†	Week after the booster date†	2 weeks post booster†	4 weeks post booster*	12 weeks post booster*
Clinical study
Demographic	+
Height/weight	+
Current medications	+				+	+
Comorbidities	+
Previous SARS-CoV-2 vaccines	+					+
Blood sample for anti-spike RBD antibody	+				+	+
Disease activity	+			+	+	+
Quality of life	+				+	+
COVID-19 disease and vaccination history	+				+	+
Disease flare-up					+	+
Randomisation		+
Reminder of allocation and to continue or withhold methotrexate		+	+
Adherence to intervention				+	+
Safety				+	+	+
Details of vaccination					+
Mechanistic
Blood sample taken for neutralisation assay‡	+				+	+
Blood sample taken for methotrexate adherence bioassay‡	+				+	+
Blood sample taken for T-cell and B-cell responses§	+				+	+

*Face to face in clinic, must take place a minimum of 6 weeks from prior vaccination against COVID-19.

†Remote via text, email or phone call.

‡In a subset of 100 participants.

§In a subset of participants where recruiting site is able to take and extract peripheral blood mononuclear cells (PBMCs). These will be analysed once additional finding is obtained.

RBD, receptor-binding domain.